Trial Outcomes & Findings for Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy (NCT NCT04736576)

NCT ID: NCT04736576

Last Updated: 2024-11-22

Results Overview

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: Baseline, Cycle 1 (1 cycle = 4 Weeks)
• Results posted on: 2024-11-22

Participant Flow

This prospective, multicenter, observational study evaluated patient reported outcome (PRO) and physical activity using smartphone-based application and wearable device in Japanese participants diagnosed with hormone receptor positive (HR+) /human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer (ABC), who received palbociclib plus endocrine therapy or endocrine monotherapy.

A total of 99 participants were enrolled into the study and were observed for maximum up to 24 Weeks.

Participant milestones

Measure	Group 1: Palbociclib Plus Endocrine Therapy Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Overall Study STARTED	78	21
Overall Study COMPLETED	74	20
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	Group 1: Palbociclib Plus Endocrine Therapy Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Overall Study Progressive disease	3	1
Overall Study Death	1	0

Baseline Characteristics

Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy

Baseline characteristics by cohort

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.	Total n=99 Participants Total of all reporting groups
Age, Continuous	57.2 Years STANDARD_DEVIATION 10.0 • n=5 Participants	56.3 Years STANDARD_DEVIATION 10.1 • n=7 Participants	57.0 Years STANDARD_DEVIATION 10.0 • n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants	21 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	78 Participants n=5 Participants	21 Participants n=7 Participants	99 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Cycle 1 (1 cycle = 4 Weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' quality of life (QOL), and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global health status scale (GHS)/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=76 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=20 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-30 (Items) [EORTC-QLQ-C30] Global Health Status (GHS) Sub-scale Score for Cycle 1	0.77 Units on a scale Standard Deviation 19.25	-0.42 Units on a scale Standard Deviation 20.67

PRIMARY outcome

Timeframe: Baseline, Cycle 2 (1 cycle = 4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=74 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=20 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 2	6.08 Units on a scale Standard Deviation 21.38	0.42 Units on a scale Standard Deviation 23.95

PRIMARY outcome

Timeframe: Baseline, Cycle 3 (1 cycle = 4 Weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=74 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=19 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 3	8.00 Units on a scale Standard Deviation 21.61	5.70 Units on a scale Standard Deviation 27.22

PRIMARY outcome

Timeframe: Baseline, Cycle 4 (1 cycle = 4 Weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=73 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=18 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 4	6.62 Units on a scale Standard Deviation 20.50	-0.93 Units on a scale Standard Deviation 30.50

PRIMARY outcome

Timeframe: Baseline, Cycle 5 (1 cycle = 4 Weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=71 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=15 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 5	4.23 Units on a scale Standard Deviation 20.79	-2.78 Units on a scale Standard Deviation 28.11

PRIMARY outcome

Timeframe: Baseline, Cycle 6 (1 cycle = 4 Weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL, and it is composed of five multi-item functional subscales (physical, role, emotional, cognitive, and social functioning), three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Responses to GHS/QOL subscales were converted to a 0 to 100 scale. For GHS/QOL subscale, higher scores indicated a better QOL. Baseline values were those measured between enrollment and the day before treatment start.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=68 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=17 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in EORTC-QLQ-C30 GHS Sub-scale Score for Cycle 6	4.78 Units on a scale Standard Deviation 22.78	2.94 Units on a scale Standard Deviation 29.01

PRIMARY outcome

Timeframe: Baseline, Week 1

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=75 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 1	18 Minutes Standard Deviation 83	13 Minutes Standard Deviation 100

PRIMARY outcome

Timeframe: Baseline, Week 2

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=74 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=20 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 2	8 Minutes Standard Deviation 114	-32 Minutes Standard Deviation 130

PRIMARY outcome

Timeframe: Baseline, Week 3

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=72 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=19 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 3	12 Minutes Standard Deviation 105	-8 Minutes Standard Deviation 159

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=70 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=18 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 4	-5 Minutes Standard Deviation 98	-43 Minutes Standard Deviation 173

PRIMARY outcome

Timeframe: Baseline, Week 5

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=73 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=18 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 5	-7 Minutes Standard Deviation 121	-50 Minutes Standard Deviation 149

PRIMARY outcome

Timeframe: Baseline, Week 6

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=67 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=17 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 6	-13 Minutes Standard Deviation 118	-27 Minutes Standard Deviation 146

PRIMARY outcome

Timeframe: Baseline, Week 7

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=72 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=16 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 7	-9 Minutes Standard Deviation 114	-67 Minutes Standard Deviation 186

PRIMARY outcome

Timeframe: Baseline, Week 8

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=71 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=15 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 8	-5 Minutes Standard Deviation 114	-29 Minutes Standard Deviation 125

PRIMARY outcome

Timeframe: Baseline, Week 9

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=70 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=17 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 9	-8 Minutes Standard Deviation 130	-20 Minutes Standard Deviation 201

PRIMARY outcome

Timeframe: Baseline, Week 10

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=70 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=15 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 10	-8 Minutes Standard Deviation 130	-4 Minutes Standard Deviation 146

PRIMARY outcome

Timeframe: Baseline, Week 11

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=67 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=17 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 11	-16 Minutes Standard Deviation 132	-57 Minutes Standard Deviation 207

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=63 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=17 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 12	-5 Minutes Standard Deviation 137	-66 Minutes Standard Deviation 190

PRIMARY outcome

Timeframe: Baseline, Week 13

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=61 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=14 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 13	-10 Minutes Standard Deviation 145	-14 Minutes Standard Deviation 112

PRIMARY outcome

Timeframe: Baseline, Week 14

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=65 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=15 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 14	-7 Minutes Standard Deviation 138	-14 Minutes Standard Deviation 136

PRIMARY outcome

Timeframe: Baseline, Week 15

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=65 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=13 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 15	-10 Minutes Standard Deviation 134	-60 Minutes Standard Deviation 133

PRIMARY outcome

Timeframe: Baseline, Week 16

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=67 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=14 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 16	-3 Minutes Standard Deviation 128	-45 Minutes Standard Deviation 179

PRIMARY outcome

Timeframe: Baseline, Week 17

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=66 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=12 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 17	-6 Minutes Standard Deviation 128	-18 Minutes Standard Deviation 106

PRIMARY outcome

Timeframe: Baseline, Week 18

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=64 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=13 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 18	2 Minutes Standard Deviation 140	-24 Minutes Standard Deviation 134

PRIMARY outcome

Timeframe: Baseline, Week 19

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=62 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=12 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 19	-2 Minutes Standard Deviation 136	-39 Minutes Standard Deviation 82

PRIMARY outcome

Timeframe: Baseline, Week 20

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=61 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=11 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 20	-6 Minutes Standard Deviation 147	-64 Minutes Standard Deviation 179

PRIMARY outcome

Timeframe: Baseline, Week 21

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=61 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=13 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 21	11 Minutes Standard Deviation 145	-32 Minutes Standard Deviation 178

PRIMARY outcome

Timeframe: Baseline, Week 22

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=62 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=15 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 22	2 Minutes Standard Deviation 138	-46 Minutes Standard Deviation 143

PRIMARY outcome

Timeframe: Baseline, Week 23

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=62 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=12 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 23	-1 Minutes Standard Deviation 140	-70 Minutes Standard Deviation 128

PRIMARY outcome

Timeframe: Baseline, Week 24

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device for 10 hours or longer during a day except for bedtime.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=61 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=15 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Sedentary Time Wearing at Week 24	-22 Minutes Standard Deviation 161	-102 Minutes Standard Deviation 176

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants analyzed for the specific timepoints.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of five multi-item functional subscales (physical [P], role [R], emotional [E], cognitive [C], and social [S] functioning [F]). Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to all functional sub-scales were converted to a 0 to 100 scale. For functional sub-scale, higher scores indicated a better level of functioning.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 SF: Change at Cycle 6	-2.45 Units on a scale Standard Deviation 21.98	1.96 Units on a scale Standard Deviation 18.52
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 PF: Change at Cycle 1	-1.58 Units on a scale Standard Deviation 14.6	-2.33 Units on a scale Standard Deviation 15.93
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 PF: Change at Cycle 2	3.15 Units on a scale Standard Deviation 14.14	1.33 Units on a scale Standard Deviation 11.77
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 PF: Change at Cycle 3	1.53 Units on a scale Standard Deviation 16.65	1.75 Units on a scale Standard Deviation 14.2
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 PF: Change at Cycle 4	3.11 Units on a scale Standard Deviation 17.43	-1.11 Units on a scale Standard Deviation 10.29
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 CF: Change at Cycle 6	-3.19 Units on a scale Standard Deviation 21.01	-7.84 Units on a scale Standard Deviation 23.66
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 SF: Change at Cycle 1	1.32 Units on a scale Standard Deviation 21.39	-0.83 Units on a scale Standard Deviation 14.78
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 SF: Change at Cycle 2	2.7 Units on a scale Standard Deviation 22.25	4.17 Units on a scale Standard Deviation 20.86
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 SF: Change at Cycle 3	1.35 Units on a scale Standard Deviation 22.03	4.39 Units on a scale Standard Deviation 19.12
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 SF: Change at Cycle 4	-0.68 Units on a scale Standard Deviation 23.31	-2.78 Units on a scale Standard Deviation 18.3
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 SF: Change at Cycle 5	-1.17 Units on a scale Standard Deviation 24.29	-6.67 Units on a scale Standard Deviation 25.04
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 PF: Change at Cycle5	2.72 Units on a scale Standard Deviation 19.7	-8.44 Units on a scale Standard Deviation 17.9
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 PF: Change at Cycle 6	0.39 Units on a scale Standard Deviation 18.71	-1.18 Units on a scale Standard Deviation 13.99
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 RF: Change at Cycle 1	-1.75 Units on a scale Standard Deviation 23.03	-4.17 Units on a scale Standard Deviation 16.11
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 RF: Change at Cycle 2	2.03 Units on a scale Standard Deviation 20.26	-1.67 Units on a scale Standard Deviation 20.16
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 RF Change at Cycle 3	4.28 Units on a scale Standard Deviation 21.02	-4.39 Units on a scale Standard Deviation 19.12
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 RF: Change at Cycle 4	2.97 Units on a scale Standard Deviation 22.8	-4.63 Units on a scale Standard Deviation 29.6
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 RF Change at Cycle 5	2.35 Units on a scale Standard Deviation 24.12	-10 Units on a scale Standard Deviation 23.4
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 RF Change at Cycle 6	0.98 Units on a scale Standard Deviation 25.58	-2.94 Units on a scale Standard Deviation 24.46
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 EF: Change at Cycle 1	8.22 Units on a scale Standard Deviation 16.69	0.83 Units on a scale Standard Deviation 16.42
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 EF: Change at Cycle 2	10.59 Units on a scale Standard Deviation 18.21	-2.5 Units on a scale Standard Deviation 10.85
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 EF: Change at Cycle 3	10.36 Units on a scale Standard Deviation 16.31	-1.75 Units on a scale Standard Deviation 12.9
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 EF: Change at Cycle 4	9.25 Units on a scale Standard Deviation 19.12	-5.09 Units on a scale Standard Deviation 19.83
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 EF: Change at Cycle 5	8.8 Units on a scale Standard Deviation 18.57	-2.22 Units on a scale Standard Deviation 11.12
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 EF: Change at Cycle 6	9.31 Units on a scale Standard Deviation 16.64	-3.43 Units on a scale Standard Deviation 15.33
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 CF: Change at Cycle 1	1.75 Units on a scale Standard Deviation 16.46	-2.5 Units on a scale Standard Deviation 19.7
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 CF: Change at Cycle 2	1.13 Units on a scale Standard Deviation 16.16	-3.33 Units on a scale Standard Deviation 17.61
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 CF: Change at Cycle 3	0.23 Units on a scale Standard Deviation 16.44	-7.02 Units on a scale Standard Deviation 23.12
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 CF: Change at Cycle 4	-091 Units on a scale Standard Deviation 20.39	-8.33 Units on a scale Standard Deviation 20.01
Change From Baseline in EORTC-QLQ-C30 Functional Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 CF: Change at Cycle 5	-2.58 Units on a scale Standard Deviation 19.03	-2.22 Units on a scale Standard Deviation 22.6

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer patients' QOL, and it's composed of three multi-item symptom scales (fatigue, nausea/vomiting, and pain), a global QOL) subscale, and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and the financial impact of cancer). Response to symptom sub-scales is based on a 4-point Likert scale and a higher score indicated more severe symptoms. Responses to all symptom sub-scales were converted to a 0 to 100 scale. A higher score indicated more severe symptoms. A 10-point or higher change in scores from baseline was considered clinically significant.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Fatigue: Change at Cycle 1	0.15 Units on a scale Standard Deviation 17.54	-1.11 Units on a scale Standard Deviation 16.48
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Fatigue: Change at Cycle 2	-2.4 Units on a scale Standard Deviation 16.27	-0.56 Units on a scale Standard Deviation 20.86
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Fatigue: Change at Cycle 3	-3.3 Units on a scale Standard Deviation 18.18	-4.68 Units on a scale Standard Deviation 19
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Fatigue: Change at Cycle 4	-1.52 Units on a scale Standard Deviation 21.14	3.7 Units on a scale Standard Deviation 21.56
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Fatigue: Change at Cycle 5	-0.78 Units on a scale Standard Deviation 22.72	3.7 Units on a scale Standard Deviation 25.77
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Fatigue: Change at Cycle 6	-0.49 Units on a scale Standard Deviation 23.39	-1.31 Units on a scale Standard Deviation 18.79
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Nausea, Vomiting: Change at Cycle 1	0.66 Units on a scale Standard Deviation 16.2	-4.17 Units on a scale Standard Deviation 25.86
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Nausea, Vomiting: Change at Cycle 2	-2.03 Units on a scale Standard Deviation 12.93	-5.83 Units on a scale Standard Deviation 23.12
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Nausea, Vomiting: Change at Cycle 3	-1.13 Units on a scale Standard Deviation 15.44	-6.14 Units on a scale Standard Deviation 23.71
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Nausea, Vomiting: Change at Cycle 4	-3.2 Units on a scale Standard Deviation 14.61	-7.41 Units on a scale Standard Deviation 24.4
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Nausea, Vomiting: Change at Cycle 5	-2.58 Units on a scale Standard Deviation 15.85	-6.67 Units on a scale Standard Deviation 28.73
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Nausea, Vomiting: Change at Cycle 6	-3.43 Units on a scale Standard Deviation 13.37	-5.88 Units on a scale Standard Deviation 26.31
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Pain: Change at Cycle 1	-0.88 Units on a scale Standard Deviation 16.75	4.17 Units on a scale Standard Deviation 16.99
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Pain: Change at Cycle 2	-4.73 Units on a scale Standard Deviation 19.99	1.67 Units on a scale Standard Deviation 23.51
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Pain: Change at Cycle 3	-5.86 Units on a scale Standard Deviation 22.65	-3.51 Units on a scale Standard Deviation 24.58
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Pain: Change at Cycle 4	-5.02 Units on a scale Standard Deviation 26.01	2.78 Units on a scale Standard Deviation 28.73
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Pain: Change at Cycle 5	-5.4 Units on a scale Standard Deviation 25.94	12.22 Units on a scale Standard Deviation 24.77
Change From Baseline in EORTC-QLQ-C30 Symptomatic Sub-scale Scores at Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 Pain: Change at Cycle 6	0 Units on a scale Standard Deviation 24.43	2.94 Units on a scale Standard Deviation 23

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

Total estimated steps taken per week were reported in this outcome measure.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 1	-164 Steps per week Standard Deviation 927	-340 Steps per week Standard Deviation 1219
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 2	0 Steps per week Standard Deviation 996	-39 Steps per week Standard Deviation 1413
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 3	-17 Steps per week Standard Deviation 1104	-397 Steps per week Standard Deviation 1349
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 4	-17 Steps per week Standard Deviation 1004	13 Steps per week Standard Deviation 1608
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 5	171 Steps per week Standard Deviation 1031	165 Steps per week Standard Deviation 1618
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 6	353 Steps per week Standard Deviation 1253	54 Steps per week Standard Deviation 1468
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 7	82 Steps per week Standard Deviation 1199	-425 Steps per week Standard Deviation 1388
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 8	147 Steps per week Standard Deviation 1376	481 Steps per week Standard Deviation 1733
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 9	263 Steps per week Standard Deviation 1242	-102 Steps per week Standard Deviation 1962
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 10	279 Steps per week Standard Deviation 1470	251 Steps per week Standard Deviation 1869
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 11	82 Steps per week Standard Deviation 1324	177 Steps per week Standard Deviation 1882
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 12	260 Steps per week Standard Deviation 1514	168 Steps per week Standard Deviation 1806
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 13	285 Steps per week Standard Deviation 1355	940 Steps per week Standard Deviation 1808
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 14	395 Steps per week Standard Deviation 1526	389 Steps per week Standard Deviation 1787
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 15	79 Steps per week Standard Deviation 1490	267 Steps per week Standard Deviation 1787
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 16	188 Steps per week Standard Deviation 1540	387 Steps per week Standard Deviation 2142
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 17	81 Steps per week Standard Deviation 1477	718 Steps per week Standard Deviation 1743
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 18	207 Steps per week Standard Deviation 1418	264 Steps per week Standard Deviation 2274
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 19	174 Steps per week Standard Deviation 1495	155 Steps per week Standard Deviation 2092
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 20	254 Steps per week Standard Deviation 1234	726 Steps per week Standard Deviation 1820
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 21	518 Steps per week Standard Deviation 1478	166 Steps per week Standard Deviation 2082
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 22	334 Steps per week Standard Deviation 1174	362 Steps per week Standard Deviation 1875
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 23	321 Steps per week Standard Deviation 1579	691 Steps per week Standard Deviation 1865
Change From Baseline in Steps Taken at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 24	447 Steps per week Standard Deviation 1860	202 Steps per week Standard Deviation 1690

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. All participants reported under 'Overall Number of Participants Analyzed' contributed data to table but may not have evaluable data for every row. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

Total estimated number of minutes of moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 18	-5 Minutes Standard Deviation 59	1 Minutes Standard Deviation 26
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 19	-5 Minutes Standard Deviation 64	-9 Minutes Standard Deviation 36
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 22	-2 Minutes Standard Deviation 40	-5 Minutes Standard Deviation 32
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 23	3 Minutes Standard Deviation 53	3 Minutes Standard Deviation 33
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 1	-1 Minutes Standard Deviation 28	-7 Minutes Standard Deviation 20
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 2	-1 Minutes Standard Deviation 38	-9 Minutes Standard Deviation 20
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 3	-4 Minutes Standard Deviation 32	-10 Minutes Standard Deviation 22
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 4	-2 Minutes Standard Deviation 41	-2 Minutes Standard Deviation 27
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 5	5 Minutes Standard Deviation 48	-4 Minutes Standard Deviation 23
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 6	4 Minutes Standard Deviation 35	-5 Minutes Standard Deviation 27
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 7	-3 Minutes Standard Deviation 58	-12 Minutes Standard Deviation 24
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 8	-2 Minutes Standard Deviation 49	1 Minutes Standard Deviation 16
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 9	5 Minutes Standard Deviation 55	-6 Minutes Standard Deviation 26
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 10	-1 Minutes Standard Deviation 57	0 Minutes Standard Deviation 23
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 11	-2 Minutes Standard Deviation 47	-4 Minutes Standard Deviation 28
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 12	1 Minutes Standard Deviation 50	-6 Minutes Standard Deviation 19
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 13	2 Minutes Standard Deviation 51	10 Minutes Standard Deviation 21
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 14	1 Minutes Standard Deviation 58	1 Minutes Standard Deviation 22
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 15	0 Minutes Standard Deviation 68	-2 Minutes Standard Deviation 20
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 16	-2 Minutes Standard Deviation 55	-8 Minutes Standard Deviation 29
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 17	-6 Minutes Standard Deviation 47	0 Minutes Standard Deviation 24
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 20	-6 Minutes Standard Deviation 44	0 Minutes Standard Deviation 30
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 21	-1 Minutes Standard Deviation 51	-11 Minutes Standard Deviation 25
Change From Baseline for Moderate to Vigorous Physical Activity (MVPA) Time at Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 Change at Week 24	3 Minutes Standard Deviation 49	-4 Minutes Standard Deviation 23

SECONDARY outcome

Timeframe: From start of study treatment up to 28 days after last dose of treatment (Up to 28 weeks)

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy.

AE= any untoward medical occurrence,could therefore be any unfavorable,unintended sign (including an abnormal laboratory finding),symptom,or disease,whether or not related to the participant's participation in the study. An SAE was any untoward medical occurrence at any dose that:resulted in death;was life-threatening(LT);required inpatient hospitalization or prolongation of existing hospitalization;resulted in persistent or significant disability/incapacity(substantial disruption of the ability to conduct normal life functions);resulted in congenital anomaly/birth defect;or an important medical event. AEs were graded(G) according to Common Terminology Criteria for AE(CTCAE) version 4.03. G3 (Severe AE),G4 (LT consequences;urgent intervention indicated),G5 (Death related to AE). TEAEs were those events with onset dates occurring during the on-treatment period (the time from start of study treatment up to 28 days after last dose). Relatedness was based on the investigator's judgement.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events Adverse Events	68 Participants	5 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events Treatment Related Adverse Events	66 Participants	5 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events Serious Adverse Events	3 Participants	0 Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Grade 3 or Higher AEs and Treatment Related Adverse Events Grade 3 or Higher AEs	54 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue severity on a five-point Likert scale. For Fatigue Severity (FS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=77 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 2 · Moderate	20 Participants	7 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 3 · Very Severe	0 Participants	1 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 4 · Mild	41 Participants	6 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 6 · Severe	9 Participants	1 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 6 · Very Severe	2 Participants	1 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Baseline · None	27 Participants	5 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Baseline · Mild	32 Participants	10 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Baseline · Moderate	11 Participants	4 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Baseline · Severe	7 Participants	2 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Baseline · Very Severe	0 Participants	0 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 1 · None	4 Participants	4 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 1 · Mild	35 Participants	8 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 1 · Moderate	27 Participants	6 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 1 · Severe	9 Participants	3 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 1 · Very Severe	2 Participants	0 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 2 · None	6 Participants	4 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 2 · Mild	41 Participants	7 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 2 · Severe	7 Participants	1 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 2 · Very Severe	2 Participants	1 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 3 · None	10 Participants	5 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 3 · Mild	40 Participants	8 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 3 · Moderate	17 Participants	6 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 3 · Severe	8 Participants	1 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 4 · None	8 Participants	3 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 4 · Moderate	19 Participants	9 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 4 · Severe	6 Participants	1 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 4 · Very Severe	1 Participants	0 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 5 · None	8 Participants	3 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 5 · Mild	38 Participants	6 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 5 · Moderate	20 Participants	5 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 5 · Severe	6 Participants	3 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 5 · Very Severe	0 Participants	0 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 6 · None	9 Participants	3 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 6 · Mild	34 Participants	8 Participants
Number of Participants According to Fatigue Severity Based on Patient Reported Outcome - Common Terminology Criteria for Adverse Events (PRO-CTCAE) FS: Cycle 6 · Moderate	14 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on fatigue interference on a five-point Likert scale. For Fatigue Interference (FI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=77 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 1 · Somewhat	23 Participants	4 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 1 · Quite a bit	6 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 1 · Very Much	2 Participants	0 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 2 · Not at all/None/Never	13 Participants	4 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 2 · A Little bit	42 Participants	9 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 2 · Somewhat	13 Participants	5 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 2 · Quite a bit	7 Participants	1 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 3 · Somewhat	13 Participants	4 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 6 · Somewhat	12 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 6 · Quite a bit	7 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 1 · Not at all/None/Never	14 Participants	7 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 1 · A Little bit	32 Participants	8 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Baseline · Quite a bit	3 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Baseline · Very Much	3 Participants	1 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 5 · Quite a bit	7 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 5 · Very Much	1 Participants	0 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 6 · Not at all/None/Never	18 Participants	4 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 6 · A Little bit	29 Participants	8 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 6 · Very Much	2 Participants	1 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Baseline · Not at all/None/Never	33 Participants	6 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Baseline · A Little bit	30 Participants	10 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Baseline · Somewhat	8 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 2 · Very Much	1 Participants	1 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 3 · Not at all/None/Never	19 Participants	7 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 3 · A Little bit	36 Participants	8 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 3 · Quite a bit	6 Participants	0 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 3 · Very Much	1 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 4 · Not at all/None/Never	19 Participants	3 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 4 · A Little bit	32 Participants	8 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 4 · Somewhat	17 Participants	6 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 4 · Quite a bit	5 Participants	2 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 4 · Very Much	2 Participants	0 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 5 · Not at all/None/Never	17 Participants	4 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 5 · A Little bit	32 Participants	7 Participants
Number of Participants According to Fatigue Interference Based on PRO-CTCAE FI: Cycle 5 · Somewhat	15 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain severity on a five-point Likert scale. For Pain Severity (PS) scoring was as follows: 0= None, 10= Mild, 20= Moderate, 30= Severe, 40= Very Severe.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=77 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 1 · Severe	9 Participants	3 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 1 · Very Severe	2 Participants	0 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 2 · None	12 Participants	3 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 2 · Mild	43 Participants	8 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 2 · Moderate	15 Participants	8 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 2 · Severe	5 Participants	0 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 2 · Very Severe	1 Participants	1 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 3 · None	15 Participants	4 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 3 · Mild	37 Participants	10 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 3 · Moderate	14 Participants	5 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 3 · Severe	9 Participants	2 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 3 · Very Severe	0 Participants	0 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 4 · None	16 Participants	2 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Baseline · None	22 Participants	10 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Baseline · Mild	33 Participants	6 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Baseline · Moderate	16 Participants	4 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Baseline · Severe	4 Participants	1 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Baseline · Very Severe	2 Participants	0 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 1 · None	8 Participants	6 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 1 · Mild	31 Participants	7 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 1 · Moderate	27 Participants	5 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 4 · Mild	35 Participants	12 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 4 · Moderate	18 Participants	4 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 4 · Severe	4 Participants	1 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 4 · Very Severe	2 Participants	0 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 5 · None	15 Participants	3 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 5 · Mild	35 Participants	6 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 5 · Moderate	15 Participants	4 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 5 · Severe	6 Participants	4 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 5 · Very Severe	1 Participants	0 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 6 · None	14 Participants	3 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 6 · Mild	30 Participants	7 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 6 · Moderate	14 Participants	5 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 6 · Severe	8 Participants	2 Participants
Number of Participants According to Pain Severity Based on PRO-CTCAE PS: Cycle 6 · Very Severe	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain interference on a five-point Likert scale. For Pain Interference (PI) scoring was as follows: 0= Not at all/None/Never, 1= A Little bit, 2: Somewhat, 3= Quite a bit, 4= Very much.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=77 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Baseline · Not at all/None/Never	39 Participants	12 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Baseline · A Little bit	24 Participants	6 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Baseline · Somewhat	8 Participants	2 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Baseline · Quite a bit	4 Participants	0 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Baseline · Very Much	2 Participants	1 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 1 · Not at all/None/Never	20 Participants	8 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 1 · A Little bit	28 Participants	8 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 1 · Somewhat	18 Participants	3 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 1 · Quite a bit	8 Participants	2 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 1 · Very Much	3 Participants	0 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 2 · Not at all/None/Never	24 Participants	6 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 2 · A Little bit	36 Participants	9 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 2 · Somewhat	10 Participants	4 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 2 · Quite a bit	3 Participants	1 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 2 · Very Much	3 Participants	0 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 3 · Not at all/None/Never	26 Participants	8 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 3 · A Little bit	32 Participants	7 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 3 · Somewhat	11 Participants	5 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 3 · Quite a bit	5 Participants	1 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 3 · Very Much	1 Participants	0 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 4 · Not at all/None/Never	29 Participants	6 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 4 · A Little bit	23 Participants	7 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 4 · Somewhat	17 Participants	5 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 4 · Quite a bit	4 Participants	1 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 4 · Very Much	2 Participants	0 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 5 · Not at all/None/Never	26 Participants	4 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 5 · A Little bit	25 Participants	6 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 5 · Somewhat	14 Participants	3 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 5 · Quite a bit	6 Participants	4 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 5 · Very Much	1 Participants	0 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 6 · Not at all/None/Never	23 Participants	4 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 6 · A Little bit	27 Participants	8 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 6 · Somewhat	7 Participants	4 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 6 · Quite a bit	9 Participants	1 Participants
Number of Participants According to Pain Interference Based on PRO-CTCAE PI: Cycle 6 · Very Much	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline, Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle=4 weeks)

Population: Evaluable population included all eligible participants who were enrolled in the study and who responded to at least 1 item or measured at least 1 metrics of study application or device. Participants were analyzed according to the enrolled group. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

The PRO-CTCAE is a PRO measurement system that includes a library of questions that measures symptomatic adverse events from the participant perspective. Participants were required to provide their responses to the questions on pain frequency on a five-point Likert scale. For Pain Frequency (PF) scoring was as follows: 0= None, 1= Rarely, 2: Occasionally, 3= Frequently, 4=Almost Constantly.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=77 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Baseline · None	18 Participants	8 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Baseline · Rarely	14 Participants	4 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Baseline · Occasionally	34 Participants	6 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Baseline · Frequently	7 Participants	1 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Baseline · Almost Constantly	4 Participants	2 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 1 · None	7 Participants	4 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 1 · Rarely	12 Participants	5 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 1 · Occasionally	39 Participants	7 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 1 · Frequently	9 Participants	4 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 1 · Almost Constantly	10 Participants	1 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 2 · None	11 Participants	3 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 2 · Rarely	14 Participants	7 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 2 · Occasionally	41 Participants	7 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 2 · Frequently	5 Participants	1 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 2 · Almost Constantly	5 Participants	2 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 3 · None	13 Participants	4 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 3 · Rarely	20 Participants	6 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 3 · Occasionally	28 Participants	8 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 3 · Frequently	10 Participants	2 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 3 · Almost Constantly	4 Participants	1 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 4 · None	15 Participants	2 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 4 · Rarely	17 Participants	5 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 4 · Occasionally	25 Participants	10 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 4 · Frequently	13 Participants	2 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 4 · Almost Constantly	5 Participants	0 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 5 · None	15 Participants	2 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 5 · Rarely	13 Participants	3 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 5 · Occasionally	23 Participants	7 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 5 · Frequently	14 Participants	5 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 5 · Almost Constantly	7 Participants	0 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 6 · None	10 Participants	2 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 6 · Rarely	19 Participants	4 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 6 · Occasionally	18 Participants	6 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 6 · Frequently	14 Participants	5 Participants
Number of Participants According to Pain Frequency Based on PRO-CTCAE PF: Cycle 6 · Almost Constantly	7 Participants	0 Participants

SECONDARY outcome

Timeframe: Before and after disease progression during the observation period (maximum up to 24 weeks)

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Sedentary time was used to assess physical activity metrics. Sedentary time was derived by Actigraph's algorithm based on raw data collected by Actigraph Insight Watch. Physical activity metrics were averaged at weekly basis which included 5 or more days of wearing the device 10 hours or longer during a day except for bedtime. Disease progression was defined as greater than (>) 25% increase in sum of longest diameter of target lesions compared to baseline.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=11 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled Before disease progression	574 Minutes Standard Deviation 246	—
Sedentary Time Before and After Disease Progression: Group 1 and 2 Pooled After disease progression	594 Minutes Standard Deviation 266	—

SECONDARY outcome

Timeframe: Before and after disease progression during the observation period (maximum up to 24 weeks)

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Total estimated steps taken per week were reported in this outcome measure. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=11 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled Before disease progression	3601 Steps per week Standard Deviation 1993	—
Steps Taken Before and After Disease Progression: Group 1 and 2 Pooled After disease progression	3599 Steps per week Standard Deviation 2017	—

SECONDARY outcome

Timeframe: Before and after disease progression during the observation period (maximum up to 24 weeks)

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure.

Total estimated number of minutes of Moderate or higher (moderate to vigorous) physical activity per date as calculated using the Staudenmayer '15 technique were reported in this outcome measure. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=11 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
MVPA Before and After Disease Progression: Group 1 and 2 Pooled Before disease progression	73 Minutes Standard Deviation 25	—
MVPA Before and After Disease Progression: Group 1 and 2 Pooled After disease progression	75 Minutes Standard Deviation 30	—

SECONDARY outcome

Timeframe: Before and after disease progression during the observation period (maximum up to 24 weeks)

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. As per statistical analysis plan, when associations for group 1 and 2 were similar, the data for group 1 and 2 were pooled. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows.

The EORTC-QLQ-C30 is a 30-item questionnaire to evaluate cancer participants' QOL,it's composed of five multi-item functional subscales (physical [P],role [R],emotional [E],cognitive [C], and social [S] functioning [F], three multi-item symptom scales (fatigue,nausea/vomiting,pain) a GHS/QOL subscale,and six single item symptom scales assessing other cancer-related symptoms (dyspnea, sleep disturbance, appetite loss, constipation,diarrhea,and the financial impact of cancer). The GHS/QOL was scored on a 7-point Likert scale where 1=very much to 7=not at all. Response to functional scales is based on a 4-point Likert scale and ranges from 'not at all' to 'very much'. Responses to GHS/QOL and all functional sub-scales were converted to a 0 to 100 scale. For GHS/QOL and functional subscale, higher scores indicated a better QOL and better level of functioning, respectively. Disease progression was defined as >25% increase in sum of longest diameter of target lesions compared to baseline.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=12 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled GHS (Before disease progression)	69.4 Units on a scale Standard Deviation 17.5	—
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled GHS (After disease progression)	53.3 Units on a scale Standard Deviation 30.0	—
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled Physical Functioning (Before disease progression)	80.6 Units on a scale Standard Deviation 15.2	—
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled Physical Functioning (After disease progression)	68.0 Units on a scale Standard Deviation 30.1	—
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled Role Functioning (Before disease progression)	86.1 Units on a scale Standard Deviation 17.2	—
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled Role Functioning (After disease progression)	65.0 Units on a scale Standard Deviation 38.0	—
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled Social Functioning (Before disease progression)	88.9 Units on a scale Standard Deviation 16.4	—
EORTC-QLQ-C30 GHS and Functional Sub-scale Score Before and After Disease Progression: Group 1 and 2 Pooled Social Functioning (After disease progression)	76.7 Units on a scale Standard Deviation 27.4	—

SECONDARY outcome

Timeframe: Day 15 of Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 6 (each cycle = 4 weeks)

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints.

Treatment satisfaction was evaluated with single item question (eg,"How satisfied are you with your current breast cancer treatment?") using the smart phone application. Responses were provided on a four-point Likert scale (dissatisfied, neutral, satisfied, very satisfied).

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=77 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 Participants Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants With Treatment Satisfaction Cycle 1 · Dissatisfied	1 Participants	1 Participants
Number of Participants With Treatment Satisfaction Cycle 1 · Neutral	40 Participants	10 Participants
Number of Participants With Treatment Satisfaction Cycle 1 · Satisfied	27 Participants	5 Participants
Number of Participants With Treatment Satisfaction Cycle 1 · Very Satisfied	9 Participants	4 Participants
Number of Participants With Treatment Satisfaction Cycle 2 · Dissatisfied	1 Participants	0 Participants
Number of Participants With Treatment Satisfaction Cycle 2 · Neutral	35 Participants	10 Participants
Number of Participants With Treatment Satisfaction Cycle 2 · Satisfied	29 Participants	7 Participants
Number of Participants With Treatment Satisfaction Cycle 2 · Very Satisfied	10 Participants	3 Participants
Number of Participants With Treatment Satisfaction Cycle 3 · Dissatisfied	1 Participants	0 Participants
Number of Participants With Treatment Satisfaction Cycle 3 · Neutral	33 Participants	7 Participants
Number of Participants With Treatment Satisfaction Cycle 3 · Satisfied	32 Participants	9 Participants
Number of Participants With Treatment Satisfaction Cycle 3 · Very Satisfied	11 Participants	2 Participants
Number of Participants With Treatment Satisfaction Cycle 4 · Dissatisfied	0 Participants	0 Participants
Number of Participants With Treatment Satisfaction Cycle 4 · Neutral	31 Participants	10 Participants
Number of Participants With Treatment Satisfaction Cycle 4 · Satisfied	33 Participants	7 Participants
Number of Participants With Treatment Satisfaction Cycle 4 · Very Satisfied	11 Participants	3 Participants
Number of Participants With Treatment Satisfaction Cycle 5 · Dissatisfied	1 Participants	0 Participants
Number of Participants With Treatment Satisfaction Cycle 5 · Neutral	30 Participants	5 Participants
Number of Participants With Treatment Satisfaction Cycle 5 · Satisfied	31 Participants	11 Participants
Number of Participants With Treatment Satisfaction Cycle 5 · Very Satisfied	13 Participants	2 Participants
Number of Participants With Treatment Satisfaction Cycle 6 · Dissatisfied	1 Participants	0 Participants
Number of Participants With Treatment Satisfaction Cycle 6 · Neutral	29 Participants	7 Participants
Number of Participants With Treatment Satisfaction Cycle 6 · Satisfied	34 Participants	11 Participants
Number of Participants With Treatment Satisfaction Cycle 6 · Very Satisfied	9 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.

Number of participants according to starting dose of palbociclib treatment (125 milligrams [mg], 100 mg and 75 mg) is reported in this outcome measure. Baseline values are those measured between enrollment and the day before treatment start.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants According to Starting Dose of Palbociclib Treatment 125 mg	73 Participants	—
Number of Participants According to Starting Dose of Palbociclib Treatment 100 mg	5 Participants	—
Number of Participants According to Starting Dose of Palbociclib Treatment 75 mg	0 Participants	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants Who Had Any Palbociclib Dose Reduction	44 Participants	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants Who Had Any Palbociclib Dose Interruption	31 Participants	—

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Safety Analysis set included all participants who received at least 1 dose of palbociclib or endocrine therapy. No participant received palbociclib treatment in Group 2. Hence, no data was reported for Group 2.

Outcome measures

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 Participants Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Number of Participants With Cycle Delay in Palbociclib Treatment	58 Participants	—

Adverse Events

Group 1: Palbociclib Plus Endocrine Therapy

Serious events: 3 serious events

Other events: 65 other events

Deaths: 1 deaths

Group 2: Endocrine Monotherapy

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 participants at risk Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 participants at risk Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Infections and infestations Pneumonia bacterial	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Death	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations SARS-CoV-2	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Other adverse events

Measure	Group 1: Palbociclib Plus Endocrine Therapy n=78 participants at risk Participants with HR+/HER2- ABC who received palbociclib plus endocrine therapy based on the discretion of the treating physician under routine clinical practice were included. Palbociclib was administered for 3 consecutive weeks followed by 1 week off treatment to comprise one cycle of 4 weeks.	Group 2: Endocrine Monotherapy n=21 participants at risk Participants with HR+/HER2- ABC who received endocrine monotherapy based on the discretion of the treating physician under routine clinical practice were included. One cycle was of 4 weeks.
Blood and lymphatic system disorders Anaemia	14.1% 11/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Febrile neutropenia	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Leukopenia	14.1% 11/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Neutropenia	52.6% 41/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Blood and lymphatic system disorders Thrombocytopenia	3.8% 3/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Abdominal pain	0.00% 0/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Constipation	2.6% 2/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Diarrhoea	5.1% 4/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Dry mouth	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Nausea	3.8% 3/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Gastrointestinal disorders Stomatitis	14.1% 11/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Fatigue	3.8% 3/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Malaise	5.1% 4/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	9.5% 2/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
General disorders Oedema peripheral	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Appendicitis	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Infections and infestations Candida infection	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Alanine aminotransferase increased	5.1% 4/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Aspartate aminotransferase increased	6.4% 5/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Gamma-glutamyltransferase increased	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Neutrophil count decreased	17.9% 14/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Platelet count decreased	5.1% 4/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Weight decreased	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations White blood cell count decreased	7.7% 6/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Investigations Blood alkaline phosphatase increased	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Metabolism and nutrition disorders Decreased appetite	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Nervous system disorders Headache	2.6% 2/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.6% 2/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Alopecia	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Dry skin	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.6% 2/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Urticaria	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Haemorrhage	0.00% 0/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Vascular disorders Hot flush	2.6% 2/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	4.8% 1/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
Skin and subcutaneous tissue disorders Rash	1.3% 1/78 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.	0.00% 0/21 • From start of study treatment up to 28 days after last dose of study treatment (up to 28 weeks) Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.

Additional Information

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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Restriction type: OTHER