Trial Outcomes & Findings for UK Ibrance Patient Program (IPP) Study (NCT NCT03921866)

NCT ID: NCT03921866

Last Updated: 2023-03-17

Results Overview

Percentage of participants according to treatment lines during anytime between breast cancer (BC) diagnosis and index date were reported in this outcome measure. Treatment lines included: 1) 1st line where, palbociclib was prescribed as the first line treatment for MBC, 2) 1st line palbociclib added to letrozole where, palbociclib was prescribed as the first line treatment along with ongoing letrozole treatment which was prescribed more than 3 months prior to initiation of palbociclib, 3) 2nd line where palbociclib was prescribed as the second or later treatment line for MBC.

• Recruitment status: COMPLETED
• Target enrollment: 191 participants
• Primary outcome timeframe: At baseline
• Results posted on: 2023-03-17

Participant Flow

Participants who had hormone receptor (HR) positive, human epidermal growth factor 2 (HER2) negative metastatic breast cancer (MBC) and were treated with palbociclib in the United Kingdom Ibrance Patient Program (IPP), in between 2018 to 2021 were observed in this study. Data collected from hospital medical records were observed both retrospectively and prospectively for approximately 3 years in this study.

Participant milestones

Measure	Palbociclib Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Overall Study STARTED	191
Overall Study COMPLETED	191
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

UK Ibrance Patient Program (IPP) Study

Baseline characteristics by cohort

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Age, Continuous	57.6 Years STANDARD_DEVIATION 12.8 • n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Race/Ethnicity, Customized White	169 Participants n=5 Participants
Race/Ethnicity, Customized Black	8 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Race/Ethnicity, Customized Missing	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants according to treatment lines during anytime between breast cancer (BC) diagnosis and index date were reported in this outcome measure. Treatment lines included: 1) 1st line where, palbociclib was prescribed as the first line treatment for MBC, 2) 1st line palbociclib added to letrozole where, palbociclib was prescribed as the first line treatment along with ongoing letrozole treatment which was prescribed more than 3 months prior to initiation of palbociclib, 3) 2nd line where palbociclib was prescribed as the second or later treatment line for MBC.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Treatment Lines 1st Line	72 Percentage of participants
Percentage of Participants According to Treatment Lines 1st Line palbociclib added to letrozole	16 Percentage of participants
Percentage of Participants According to Treatment Lines 2nd Line	10 Percentage of participants
Percentage of Participants According to Treatment Lines Unclassified	2 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Time from letrozole was defined as duration from the start date of letrozole which was ongoing at the time of palbociclib treatment initiation up to the index date.

Outcome measures

Measure	Palbociclib n=25 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Time From Letrozole to Palbociclib Initiation	430.8 Days Standard Deviation 770.8

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here "number analyzed" signifies number of participants evaluable for specified rows.

Number of participants with menopausal status as pre-menopausal, peri-menopausal, post-menopausal and not applicable (NA), during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants With Menopausal Status At initial diagnosis: Pre-menopausal	86 Participants
Number of Participants With Menopausal Status At initial diagnosis: Post-menopausal	94 Participants
Number of Participants With Menopausal Status At initial diagnosis: Peri-menopausal	6 Participants
Number of Participants With Menopausal Status At initial diagnosis: NA	1 Participants
Number of Participants With Menopausal Status At initial diagnosis: Missing	4 Participants
Number of Participants With Menopausal Status At recurrence of disease: Pre-menopausal	35 Participants
Number of Participants With Menopausal Status At recurrence of disease: Post-menopausal	94 Participants
Number of Participants With Menopausal Status At recurrence of disease: Peri-menopausal	5 Participants
Number of Participants With Menopausal Status Metastatic setting: Pre-menopausal	55 Participants
Number of Participants With Menopausal Status Metastatic setting: Post-menopausal	127 Participants
Number of Participants With Menopausal Status Metastatic setting: Peri-menopausal	8 Participants
Number of Participants With Menopausal Status Metastatic setting: NA	1 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Disease free interval was defined as the time from the date of last known neo-adjuvant hormone therapy to the date of MBC diagnosis.

Outcome measures

Measure	Palbociclib n=166 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Disease Free Interval at Palbociclib Initiation More than 12 months	29 Percentage of participants
Percentage of Participants According to Disease Free Interval at Palbociclib Initiation Less than or equal to (<=)12 months	37 Percentage of participants
Percentage of Participants According to Disease Free Interval at Palbociclib Initiation De novo metastatic disease	34 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with de novo and recurrent metastatic disease, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis Participants with de novo metastatic disease	30 Percentage of participants
Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis Participants with recurrent disease	70 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Percentage of participants with lymph nodes involvement during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.

Outcome measures

Measure	Palbociclib n=188 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Lymph Nodes Involvement Initial diagnosis	58 Percentage of participants
Percentage of Participants With Lymph Nodes Involvement De novo metastatic	58 Percentage of participants
Percentage of Participants With Lymph Nodes Involvement Non de novo metastatic	58 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Number of lymph nodes involved during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.

Outcome measures

Measure	Palbociclib n=96 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Lymph Nodes Involved Initial diagnosis	4.4 Lymph nodes Standard Deviation 4.4
Number of Lymph Nodes Involved De novo metastatic	4.4 Lymph nodes Standard Deviation 3
Number of Lymph Nodes Involved Non de novo metastatic	4.4 Lymph nodes Standard Deviation 4.8

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "number analyzed" signifies number of participants evaluable for specified rows.

Number of participants with estrogen, progesterone and HER2 receptor status during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at initial diagnosis: Positive	178 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at initial diagnosis: Negative	2 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at initial diagnosis: Missing	11 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at initial diagnosis: Positive	1 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at initial diagnosis: Negative	170 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at initial diagnosis: Missing	20 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at initial diagnosis: Positive	38 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at initial diagnosis: Negative	25 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at initial diagnosis: Not known	14 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at initial diagnosis: Missing	114 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at recurrence of disease: Positive	73 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at recurrence of disease: Negative	2 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at recurrence of disease: Missing	2 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at recurrence of disease: Negative	75 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at recurrence of disease: Missing	2 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at recurrence of disease: Positive	38 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at recurrence of disease: Negative	25 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at recurrence of disease: Not known	14 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at recurrence of disease: Missing	57 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at metastatic setting: Positive	130 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at metastatic setting: Negative	2 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at metastatic setting: No rebiopsy in metastatic setting	50 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Estrogen receptor status at metastatic setting: Missing	9 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at metastatic setting: Negative	131 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at metastatic setting: No rebiopsy in metastatic setting	50 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status HER2 receptor status at metastatic setting: Missing	10 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at metastatic setting: Positive	76 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at metastatic setting: Negative	35 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at metastatic setting: Not known	22 Participants
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status Progesterone receptor status at metastatic setting: Missing	1 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants who had rebiopsy during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=127 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Had Rebiopsy After Metastatic Disease Diagnosis	61 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Percentage of participants with tumor stages 0, 1, 2, 3 and 4, as per Tumor, Node, Metastasis (TNM) staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, tumor stage 0 indicates main tumor cannot be found; tumor stages 1, 2, 3 and 4 refers to the size and/or extent of the main tumor. The higher the number, the larger the tumor and/or the more it has spread into nearby tissues. Data for this outcome measure is also presented by de novo status.

Outcome measures

Measure	Palbociclib n=160 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Tumor Stage At initial diagnosis: Stage 0	5 Percentage of participants
Percentage of Participants According to Tumor Stage At initial diagnosis: Stage 1	19 Percentage of participants
Percentage of Participants According to Tumor Stage At initial diagnosis: Stage 2	51 Percentage of participants
Percentage of Participants According to Tumor Stage At initial diagnosis: Stage 3	21 Percentage of participants
Percentage of Participants According to Tumor Stage At initial diagnosis: Stage 4	4 Percentage of participants
Percentage of Participants According to Tumor Stage De novo metastatic: Stage 0	12 Percentage of participants
Percentage of Participants According to Tumor Stage De novo metastatic: Stage 1	8 Percentage of participants
Percentage of Participants According to Tumor Stage De novo metastatic: Stage 2	39 Percentage of participants
Percentage of Participants According to Tumor Stage De novo metastatic: Stage 3	29 Percentage of participants
Percentage of Participants According to Tumor Stage De novo metastatic: Stage 4	12 Percentage of participants
Percentage of Participants According to Tumor Stage Non de novo metastatic: Stage 0	2 Percentage of participants
Percentage of Participants According to Tumor Stage Non de novo metastatic: Stage 1	23 Percentage of participants
Percentage of Participants According to Tumor Stage Non de novo metastatic: Stage 2	56 Percentage of participants
Percentage of Participants According to Tumor Stage Non de novo metastatic: Stage 3	18 Percentage of participants
Percentage of Participants According to Tumor Stage Non de novo metastatic: Stage 4	1 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Percentage of participants with nodal stages 0, 1, 2 and 3, as per TNM staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, nodal stage 0 indicates no cancer in regional lymph nodes; nodal stages 1= cancer has spread to 1 to 3 lymph nodes; nodal stage 2= cancer has spread to 4 to 9 lymph nodes, nodal stage 3= indicates the cancer has spread to 10 or more lymph nodes. Data for this outcome measure is also presented by de novo status.

Outcome measures

Measure	Palbociclib n=157 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Nodal Status At initial diagnosis: Stage 0	39 Percentage of participants
Percentage of Participants According to Nodal Status At initial diagnosis: Stage 1	38 Percentage of participants
Percentage of Participants According to Nodal Status At initial diagnosis: Stage 2	11 Percentage of participants
Percentage of Participants According to Nodal Status At initial diagnosis: Stage 3	12 Percentage of participants
Percentage of Participants According to Nodal Status De novo metastatic: Stage 0	35 Percentage of participants
Percentage of Participants According to Nodal Status De novo metastatic: Stage 1	30 Percentage of participants
Percentage of Participants According to Nodal Status De novo metastatic: Stage 2	15 Percentage of participants
Percentage of Participants According to Nodal Status De novo metastatic: Stage 3	20 Percentage of participants
Percentage of Participants According to Nodal Status Non de novo metastatic: Stage 0	41 Percentage of participants
Percentage of Participants According to Nodal Status Non de novo metastatic: Stage 1	41 Percentage of participants
Percentage of Participants According to Nodal Status Non de novo metastatic: Stage 2	9 Percentage of participants
Percentage of Participants According to Nodal Status Non de novo metastatic: Stage 3	9 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Percentage of participants with metastasis stages 0 and 1, as per TNM staging system, during anytime between MBC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, metastasis stage 0 indicates cancer has not spread to other parts of the body; metastasis stage 1 indicates that the cancer has spread to distant parts of the body. Data for this outcome measure is also presented by de novo status.

Outcome measures

Measure	Palbociclib n=174 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Metastasis At initial diagnosis: Stage 0	64 Percentage of participants
Percentage of Participants According to Metastasis At initial diagnosis: Stage 1	36 Percentage of participants
Percentage of Participants According to Metastasis De novo metastatic: Stage 1	100 Percentage of participants
Percentage of Participants According to Metastasis Non de novo metastatic: Stage 0	96 Percentage of participants
Percentage of Participants According to Metastasis Non de novo metastatic: Stage 1	4 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Outcome measures

Measure	Palbociclib n=162 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Tumor Size at Palbociclib Initiation At Initial diagnosis	35.4 Millimeters Standard Deviation 27.5
Tumor Size at Palbociclib Initiation De novo metastatic status	40.9 Millimeters Standard Deviation 36
Tumor Size at Palbociclib Initiation Non de novo metastatic status	33.1 Millimeters Standard Deviation 22.9

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Percentage of participants with tumor grades, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Grades of disease was classified as grades 1, 2 and 3. As per TNM system, grade 1= well differentiated cells, low grade; grade 2= moderately differentiated cells, intermediate grade and grade 3= poorly differentiated cells, high grade.

Outcome measures

Measure	Palbociclib n=170 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Tumor Grade At initial diagnosis: Grade 1	10 Percentage of participants
Percentage of Participants According to Tumor Grade At initial diagnosis: Grade 2	56 Percentage of participants
Percentage of Participants According to Tumor Grade At initial diagnosis: Grade 3	34 Percentage of participants
Percentage of Participants According to Tumor Grade De novo metastatic: Grade 1	4 Percentage of participants
Percentage of Participants According to Tumor Grade De novo metastatic: Grade 2	63 Percentage of participants
Percentage of Participants According to Tumor Grade De novo metastatic: Grade 3	33 Percentage of participants
Percentage of Participants According to Tumor Grade Non de novo metastatic: Grade 1	12 Percentage of participants
Percentage of Participants According to Tumor Grade Non de novo metastatic: Grade 2	53 Percentage of participants
Percentage of Participants According to Tumor Grade Non de novo metastatic: Grade 3	35 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants with Ki-67 protein proliferation index during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.

Outcome measures

Measure	Palbociclib n=173 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Ki-67 Protein Proliferation Index Recorded	14 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.

Outcome measures

Measure	Palbociclib n=25 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Ki-67 Protein Proliferation Index	30.8 Percentage of cells staining for Ki-67 Standard Deviation 23

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

ECOG PS measured quality of life of cancer participants on a 0 to 5 scale; 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light/sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up >50 % of waking hours; 3= capable of only limited self-care, confined to bed/ chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Higher scores indicated worsening of quality of life.

Outcome measures

Measure	Palbociclib n=112 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At initial diagnosis: Score 0	68 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At initial diagnosis: Score 1	25 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At initial diagnosis: Score 2	8 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At recurrence of disease: Score 0	45 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At recurrence of disease: Score1	40 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At recurrence of disease: Score 2	15 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At metastatic diagnosis: Score 0	55 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At metastatic diagnosis: Score1	32 Percentage of participants
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS) At metastatic diagnosis: Score 2	12 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants with recurrence type during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=127 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Recurrence Type Distant	77 Percentage of participants
Percentage of Participants With Recurrence Type Locoregional	23 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants according to number of metastatic sites during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=146 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Number of Metastatic Sites 1	45 Percentage of participants
Percentage of Participants According to Number of Metastatic Sites 2	36 Percentage of participants
Percentage of Participants According to Number of Metastatic Sites 3	14 Percentage of participants
Percentage of Participants According to Number of Metastatic Sites 4 or more	5 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants according to location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=189 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Location of Metastases Non-visceral	67 Percentage of participants
Percentage of Participants According to Location of Metastases Visceral	33 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants with non-visceral location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=127 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Non-Visceral Location of Metastases Bone only metastases	67 Percentage of participants
Percentage of Participants With Non-Visceral Location of Metastases Other non-visceral	33 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Number of participants according to metastatic sites with locoregional recurrence, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Metastatic sites with locoregional recurrence included bone, breast, lung, pleural, regional lymph nodes and other sites.

Outcome measures

Measure	Palbociclib n=29 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants According to Metastatic Sites With Locoregional Recurrence Bone	5 Participants
Number of Participants According to Metastatic Sites With Locoregional Recurrence Breast	3 Participants
Number of Participants According to Metastatic Sites With Locoregional Recurrence Lung	2 Participants
Number of Participants According to Metastatic Sites With Locoregional Recurrence Pleural	1 Participants
Number of Participants According to Metastatic Sites With Locoregional Recurrence Regional lymph nodes	2 Participants
Number of Participants According to Metastatic Sites With Locoregional Recurrence Other sites	16 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Duration of BC disease was the time duration between date of BC disease diagnosis to palbociclib treatment initiation date.

Outcome measures

Measure	Palbociclib n=190 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Duration of Disease at Initiation of Palbociclib	225.9 Months Interval 1.9 to 1722.4

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants who received chemotherapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Chemotherapy in Adjuvant or Neoadjuvant Setting	46 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants who received chemotherapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Chemotherapy in Advanced, Disease Modifying or Metastatic Setting	15 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Number of lines of prior chemotherapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=29 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Lines of Prior Chemotherapy for Metastatic Disease	1.4 Chemotherapy lines Standard Deviation 0.7

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants who received LHRH or chemotherapy, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=53 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Luteinizing Hormone Releasing Hormone (LHRH) or Chemotherapy	96 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants who received endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Endocrine Therapy in Adjuvant or Neoadjuvant Setting	61 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Number of participants with types of endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=137 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Adjuvant endocrine therapy: Anastrozole	19 Participants
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Adjuvant endocrine therapy: Exemestane	11 Participants
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Adjuvant endocrine therapy: Letrozole	16 Participants
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Adjuvant endocrine therapy: Tamoxifen	86 Participants
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Adjuvant endocrine therapy: Other	5 Participants
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Neoadjuvant endocrine therapy: Anastrozole	2 Participants
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Neoadjuvant endocrine therapy: Letrozole	2 Participants
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting Neoadjuvant endocrine therapy: Tamoxifen	3 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants who received endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting	38 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants with type of endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=99 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting Anastrozole	4 Percentage of participants
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting Exemestane	13 Percentage of participants
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting Fulvestrant	3 Percentage of participants
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting Letrozole	54 Percentage of participants
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting Other	12 Percentage of participants
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting Tamoxifen	14 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Number of lines of prior endocrine therapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=73 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Lines of Prior Endocrine Therapy for Metastatic Disease	1.4 Endocrine therapy lines Standard Deviation 0.6

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Number of participants who received radiotherapy in advanced, disease modifying or metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants Who Received Radiotherapy in Advanced, Disease Modifying or Metastatic Setting	53 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants who received concomitant medications, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Concomitant Medications	100 Percentage of participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Number of participants with concomitant medications prescribed along with goserelin, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Goserelin is the generic drug with a brand name Zoladex.

Outcome measures

Measure	Palbociclib n=17 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants With Concomitant Medications Prescribed Along With Goserelin Zoladex and Anastrozole	1 Participants
Number of Participants With Concomitant Medications Prescribed Along With Goserelin Zoladex and Letrozole	10 Participants
Number of Participants With Concomitant Medications Prescribed Along With Goserelin Zoladex and Tamoxifen then Exemestane	1 Participants
Number of Participants With Concomitant Medications Prescribed Along With Goserelin Zoladex only	4 Participants
Number of Participants With Concomitant Medications Prescribed Along With Goserelin Zoladex, Exemestane, Letrozole and Tamoxifen	1 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Number of participants according to number of prior treatments in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants According to Number of Prior Treatments in Metastatic Setting 0	83 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 1	58 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 2	24 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 3	12 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 4	7 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 5	4 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 6	1 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 8	1 Participants
Number of Participants According to Number of Prior Treatments in Metastatic Setting 10	1 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Number of participants according to number of prior chemotherapy and hormone therapy in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting 0	108 Participants
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting 1	46 Participants
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting 2	24 Participants
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting 3	6 Participants
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting 4	6 Participants
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting 5	1 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Number of participants according to number of prior chemotherapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting 1	19 Participants
Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting 0	162 Participants
Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting 2	7 Participants
Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting 3	3 Participants

PRIMARY outcome

Timeframe: At baseline

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Number of participants according to number of prior hormone therapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting 0	118 Participants
Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting 1	52 Participants
Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting 2	17 Participants
Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting 3	3 Participants
Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting 4	1 Participants

SECONDARY outcome

Timeframe: Data collected at index date (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with their starting dose of palbociclib were reported.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Their Starting Dose of Palbociclib 125 milligrams (mg)/day	97 Percentage of participants
Percentage of Participants With Their Starting Dose of Palbociclib 100 mg/day	3 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants who received endocrine therapy along with palbociclib were reported in this outcome measure. Endocrine therapy includes anastrozole, exemestane, fulvestrant and letrozole.

Outcome measures

Measure	Palbociclib n=190 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib Anastrozole	3 Percentage of participants
Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib Exemestane	7 Percentage of participants
Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib Fulvestrant	1 Percentage of participants
Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib Letrozole	89 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with dose reductions and treatment discontinuation were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Dose Reductions and Treatment Discontinuation Dose reduction	41 Percentage of participants
Percentage of Participants With Dose Reductions and Treatment Discontinuation Treatment discontinuation	54 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Number of participants with reasons for palbociclib discontinuation were reported in this outcome measure. Disease progression (PD) was defined as greater than or equal to (>=)20 percent (%) increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Adverse drug reactions (ADR) were defined as unintended, harmful events attributed to the use of drug. As per World Health Organisation (WHO) criteria for hematologic and nonhematologic toxicity grade 3 was defined as the severe/worst grade.

Outcome measures

Measure	Palbociclib n=103 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants With Reasons for Palbociclib Discontinuation Adverse drug reaction	3 Participants
Number of Participants With Reasons for Palbociclib Discontinuation Hematologic toxicity: Grade 3	1 Participants
Number of Participants With Reasons for Palbociclib Discontinuation Non-hematologic: Grade 3	1 Participants
Number of Participants With Reasons for Palbociclib Discontinuation Progression of disease	83 Participants
Number of Participants With Reasons for Palbociclib Discontinuation Other	15 Participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with temporary discontinuation of palbociclib were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Temporary Discontinuation	40 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants according to time to dose reduction after palbociclib initiation in 1st line therapy were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=137 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Time to Dose Reduction in First Line Therapy Within 3 months	19 Percentage of participants
Percentage of Participants According to Time to Dose Reduction in First Line Therapy Between 3 to 6 months	11 Percentage of participants
Percentage of Participants According to Time to Dose Reduction in First Line Therapy Over 6 months	12 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Time to palbociclib discontinuation were observed in participants who permanently discontinued palbociclib and were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=103 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Time to Palbociclib Discontinuation	8.3 Months Interval 0.1 to 24.0

SECONDARY outcome

Timeframe: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows. Participant can be included in more than 1 category.

Number of participants according to lines of treatment after progression were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=103 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Participants With First 3 Lines of Treatment After Progression 1st line treatment	80 Participants
Number of Participants With First 3 Lines of Treatment After Progression 2nd line treatment	42 Participants
Number of Participants With First 3 Lines of Treatment After Progression 3rd line treatment	20 Participants

SECONDARY outcome

Timeframe: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Doses of drugs prescribed for first 3 lines of treatment after progression were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=79 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Doses Prescribed for First 3 Lines of Treatment After Progression 1st line - dose prescribed	909.4 Milligrams Standard Deviation 1170.4
Doses Prescribed for First 3 Lines of Treatment After Progression 2nd line - dose prescribed	560.6 Milligrams Standard Deviation 1014.1
Doses Prescribed for First 3 Lines of Treatment After Progression 3rd line - dose prescribed	362.4 Milligrams Standard Deviation 531.0

SECONDARY outcome

Timeframe: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies participants evaluable for this outcome measure for specified rows.

Time duration of first 3 lines of treatment after progression up to lost to follow up or end of follow up period, whichever occurred first were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=59 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Duration of First 3 Lines of Treatment After Progression 1st line treatment	77.0 Days Interval 0.0 to 592.0
Duration of First 3 Lines of Treatment After Progression 2nd line treatment	67.0 Days Interval 0.0 to 304.0
Duration of First 3 Lines of Treatment After Progression 3rd line treatment	42 Days Interval 0.0 to 91.0

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Number of 28-day cycles completed for palbociclib treatment were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Completed Cycles of Palbociclib	15.0 Cycles Standard Deviation 8.8

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Percentage of participants who received letrozole and fulvestrant along with palbociclib were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=190 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Who Received Letrozole and Fulvestrant With Palbociclib Letrozole	89 Percentage of participants
Percentage of Participants Who Received Letrozole and Fulvestrant With Palbociclib Fulvestrant	1 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Progression free survival (PFS) was defined as the time from the index date to the date of first documented disease progression (PD) or death. PD was defined as >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Percentage of participants with progression free survival after index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Progression Free Survival Following Palbociclib Initiation	53 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants who were alive after palbociclib initiation were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Alive Following Palbociclib Initiation	71 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

CR was defined as disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures less than (<)10 mm; PR was defined as >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Partial Response (PR) and Complete Response (CR) Following Palbociclib Initiation Complete response	2 Percentage of participants
Percentage of Participants With Partial Response (PR) and Complete Response (CR) Following Palbociclib Initiation Partial response	40 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

SD was defined as neither shrinkage for CR or PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Stable Disease (SD) Following Palbociclib Initiation	48 Percentage of participants

SECONDARY outcome

Timeframe: From index date to PD or death whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

PFS was defined as the time from the index date to the date of first documented PD or death. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Progression Free Survival (PFS)	19.5 Months Interval 14.5 to Upper limit of 95% confidence interval (CI) could not be calculated due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From index date until date of death or date of censoring (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the last date of data collection were censored.

Outcome measures

Measure	Palbociclib n=190 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Overall Survival (OS)	NA Months Median and 95% CI could not be calculated due to less number of participants with event.

SECONDARY outcome

Timeframe: From index date till date of BOR or date of censoring (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Time to achieving BOR: time from index date until achievement of BOR: CR or PR, if CR was not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm. Appearance of 1 or more new lesions; Alive participants with no events were censored at date of last response assessment.

Outcome measures

Measure	Palbociclib n=185 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Time to Achieving Best Overall Response (BOR)	3.5 Months Interval 0.1 to 23.8

SECONDARY outcome

Timeframe: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Duration of follow-up period defined as the duration from index date until lost to follow up or end of follow up period, whichever occurred first, were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=190 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Duration of Follow-up Period	20.8 Months Standard Deviation 6

SECONDARY outcome

Timeframe: From index date till BR (CR or PR, whichever occurred first), SD, PD or date of censoring (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with BR, PD and SD to palbociclib were reported in this outcome measure. BR was recorded for CR or PR. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Overall: CR	2 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Overall: PR	40 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Overall: PD	7 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Overall: SD	48 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib De novo status: CR	2 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib De novo status: PR	40 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib De novo status: PD	7 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib De novo status: SD	48 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Relapse status: CR	2 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Relapse status: PR	40 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Relapse status: PD	7 Percentage of participants
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib Relapse status: SD	48 Percentage of participants

SECONDARY outcome

Timeframe: From index date till BR or date of censoring (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Time to BR: time from index date until achievement of BR:CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.

Outcome measures

Measure	Palbociclib n=185 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Time to Best Response (BR) Overall	3.5 Months Interval 0.1 to 23.8
Time to Best Response (BR) De novo status: Metastatic disease	3.4 Months Interval 0.1 to 19.7
Time to Best Response (BR) De novo status: Recurrent disease	3.6 Months Interval 0.2 to 23.8
Time to Best Response (BR) Relapse status: More than 12 months	3.9 Months Interval 1.0 to 23.2
Time to Best Response (BR) Relapse status: De novo metastatic disease	3.4 Months Interval 0.1 to 19.7
Time to Best Response (BR) Relapse status: <=12 months	3.8 Months Interval 0.2 to 23.8
Time to Best Response (BR) Relapse status: Missing	3.4 Months Interval 0.3 to 11.0

SECONDARY outcome

Timeframe: From index date till first documented CR or PR or date of censoring (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Time to first response: time from index date until achievement of first response of CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.

Outcome measures

Measure	Palbociclib n=80 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Time to First Response Overall	115.5 Days Interval 4.0 to 724.0
Time to First Response De novo status: Metastatic disease	93.0 Days Interval 4.0 to 599.0
Time to First Response De novo status: Recurrent disease	127.5 Days Interval 53.0 to 724.0
Time to First Response Relapse status: More than 12 months	105.0 Days Interval 63.0 to 706.0
Time to First Response Relapse status: De novo metastatic disease	93.0 Days Interval 4.0 to 599.0
Time to First Response Relapse status: <=12 months	166.0 Days Interval 76.0 to 724.0
Time to First Response Relapse status: Missing	116.0 Days Interval 53.0 to 258.0

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per microliter (mcL) in blood and was classified as per Common Toxicity Criteria (CTC) version 2.0 criteria: grade 1 (mild) with an absolute neutrophil count (ANC) of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with all grades, grade 3 and grade 4 were reported in this outcome measure. All grades category included grades 1 to grade 4.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Neutropenia Post-Palbociclib Initiation All grades	88 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation Grade 3	40 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation Grade 4	7 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.

Outcome measures

Measure	Palbociclib n=190 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes Grade 2	14 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes Grade 1	11 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes Grade 3	25 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes Grade 4	3 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements Grade 1	10 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements Grade 2	31 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements Grade 3	40 Percentage of participants
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements Grade 4	7 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with grade 3 and 4 were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to the Severe Grade of Neutropenia Grade 3	37 Percentage of participants
Percentage of Participants According to the Severe Grade of Neutropenia Grade 4	6 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Febrile neutropenia (FN) was defined as an ANC of < 1.0 x 10^9 cells/L predicted to fall below 0.5 x 10^9 cells/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Febrile Neutropenia Post-Palbociclib Initiation	3 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with gastro-intestinal toxicities as diarrhea, nausea and vomiting after index date were reported in this outcome measure. As per CTC version 2.0 criteria, for diarrhea: grade 1 (mild)- less than 4 stools per day, grade 2 (moderate)- 4 to 6 stools per day, grade 3 (severe)- >=7 stools per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Vomiting: grade 1 (mild)- 1 episode per day , grade 2 (moderate)- 2 to 5 episodes per day, grade 3 (severe)- >=6 episodes per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Nausea: grade 1 (mild)- able to eat, grade 2 (moderate)- oral intake significantly reduced, grade 3 (severe)- no significant intake and requiring intravenous fluids.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Diarrhea: All grades	16 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Diarrhea: Grade 3	1 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Diarrhea: Grade not available	5 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Nausea: All grades	18 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Nausea: Grade 1	12 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Nausea: Grade 2	1 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Nausea: Grade not available	5 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Vomiting: All grades	11 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Vomiting: Grade 1	6 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Vomiting: Grade 2	1 Percentage of participants
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation Vomiting: Grade not available	4 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with at least one of the adverse events (neutropenia, diarrhea, nausea, and vomiting) after index date were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Adverse Events During Follow-up	72 Percentage of participants

SECONDARY outcome

Timeframe: From index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Absolute values for hematology parameter- hemoglobin, were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=183 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Hematology Parameter in First 6 Months Following Palbociclib Initiation: Hemoglobin	120.5 Grams per liter Standard Deviation 10

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Absolute values for hematology parameters- white blood cell (WBC) counts, absolute neutrophil counts (ANC) and platelet counts (PLT), were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=183 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts WBC	4 10^9 cells per liter Standard Deviation 1.5
Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts ANC	2 10^9 cells per liter Standard Deviation 1.2
Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts PLT	233.6 10^9 cells per liter Standard Deviation 63.8

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Absolute values for liver function parameters- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP), were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=174 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase AST	26.9 International units per liter Standard Deviation 17.9
Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase ALT	24.5 International units per liter Standard Deviation 19.4
Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase ALP	100.8 International units per liter Standard Deviation 69.3

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Absolute values for liver function parameter- albumin, were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=178 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Albumin	42.8 Grams per deciliter Standard Deviation 4.7

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Absolute values for liver function parameter- bilirubin, were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=175 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Bilirubin	6.9 Milligrams per deciliter Standard Deviation 3.6

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Absolute values for bone profile parameters- calcium and phosphate were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=167 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Bone Profile Parameters in First 6 Months Following Palbociclib Initiation: Calcium and Phosphate Calcium	2.3 Millimoles per liter Standard Deviation 0.1
Absolute Values for Bone Profile Parameters in First 6 Months Following Palbociclib Initiation: Calcium and Phosphate Phosphate	1.1 Millimoles per liter Standard Deviation 0.2

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure and "number analyzed" signifies number of participants evaluable for specified rows.

Absolute values for clinical chemistry parameters- potassium, sodium and urea were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=168 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea Potassium	4.3 Millimoles per liter Standard Deviation 0.4
Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea Sodium	139.4 Millimoles per liter Standard Deviation 10.6
Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea Urea	5.8 Millimoles per liter Standard Deviation 11.2

SECONDARY outcome

Timeframe: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Absolute values for clinical chemistry parameter- creatinine, were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=168 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Absolute Values for Clinical Chemistry Parameter in First 6 Months Following Palbociclib Initiation: Creatinine	70.6 Micromoles per liter Standard Deviation 16.1

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants with inpatient admissions and outpatient visits were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Inpatient Admissions and Outpatient Visits Inpatient Admissions	28 Percentage of participants
Percentage of Participants With Inpatient Admissions and Outpatient Visits Outpatient Visits	77 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Palbociclib n=53 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Inpatient Admissions Per Participant	1.4 Admissions per participant Standard Deviation 0.7

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Palbociclib n=147 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of Outpatient Visits Per Participant	9.5 Visits per participant Standard Deviation 7.5

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Palbociclib n=73 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Type of Hospital Admission Accident and emergency	86 Percentage of participants
Percentage of Participants With Type of Hospital Admission Planned	14 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure. One participant could have more than 1 reason for hospital admission.

Outcome measures

Measure	Palbociclib n=73 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants With Reasons for Hospital Admission Blood tests	5 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Breathlessness	8 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Collapse and transfer to the ward	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Hypocalcemia	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Hypoxia	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Incidental deep vein thrombosis (DVT)	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Palliative Mastectomy	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Pleural Effusion	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Pyrexia	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Sepsis	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Shortness of breath and clinically progressive disease	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Small bowel obstruction: no clear cause	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Surgery: appendicectomy	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Swollen/Painful left arm seen by general practitioner (GP)/DVT/cellulitis	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Temperature	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Transfusion	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Unwell	1 Percentage of participants
Percentage of Participants With Reasons for Hospital Admission Urgent review	66 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Duration of hospital stay was the time from the date of hospital entry to date of hospital discharge.

Outcome measures

Measure	Palbociclib n=67 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Duration of Inpatient Hospital Stay	3 Days Interval 1.0 to 54.0

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could have more than one event.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Reasons of Outpatient Visit Bloods	40 Events
Reasons of Outpatient Visit Bloods, Zoladex and Denosumab	3 Events
Reasons of Outpatient Visit Capecitabine pick up	1 Events
Reasons of Outpatient Visit Chemotherapy	44 Events
Reasons of Outpatient Visit Dalteparin administration	1 Events
Reasons of Outpatient Visit Denosumab	27 Events
Reasons of Outpatient Visit Denosumab + bloods	2 Events
Reasons of Outpatient Visit Denosumab + Palbociclib handout	1 Events
Reasons of Outpatient Visit Discontinuation of palbociclib discussed	1 Events
Reasons of Outpatient Visit Follow-up	1041 Events
Reasons of Outpatient Visit Genetics testing	2 Events
Reasons of Outpatient Visit Given treatment	5 Events
Reasons of Outpatient Visit Goserelin + Denosumab	1 Events
Reasons of Outpatient Visit Goserelin treatment	21 Events
Reasons of Outpatient Visit Home visit from palliative care	3 Events
Reasons of Outpatient Visit Information about disease/treatment	123 Events
Reasons of Outpatient Visit Insertion of central venous access device	1 Events
Reasons of Outpatient Visit Lymphoedema review	2 Events
Reasons of Outpatient Visit Medical concerns	12 Events
Reasons of Outpatient Visit Oral chemotherapy clinic	22 Events
Reasons of Outpatient Visit Palbociclib pick up, Zoladex and Denosumab	9 Events
Reasons of Outpatient Visit Palbociclib Initiation	2 Events
Reasons of Outpatient Visit Palliative care appointment	6 Events
Reasons of Outpatient Visit Peripherally inserted central catheter (PICC) line insertion	2 Events
Reasons of Outpatient Visit Pick up Cyclophosphamide /Methotrexate	2 Events
Reasons of Outpatient Visit Pick up palbociclib	3 Events
Reasons of Outpatient Visit Radiotherapy appointment	1 Events
Reasons of Outpatient Visit Review before discharge	1 Events
Reasons of Outpatient Visit Treatment initiation	1 Events
Reasons of Outpatient Visit Trial initiation (1st dose & consent)	1 Events
Reasons of Outpatient Visit Zoledronic acid	13 Events

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could consult more than one health care professional.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Type of Health Care Professional Consultations During Outpatient Visit Advanced nurse practitioner (ANP)	47 Consultations
Type of Health Care Professional Consultations During Outpatient Visit Consultant	772 Consultations
Type of Health Care Professional Consultations During Outpatient Visit Nurse	284 Consultations
Type of Health Care Professional Consultations During Outpatient Visit Pharmacist	7 Consultations
Type of Health Care Professional Consultations During Outpatient Visit Specialist registrar (SpR)	209 Consultations
Type of Health Care Professional Consultations During Outpatient Visit Other	45 Consultations
Type of Health Care Professional Consultations During Outpatient Visit Not known	30 Consultations

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study.

Percentage of participants who contacted CNS by phone calls and AOS either by phone calls or visits were reported in this outcome measure.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants Contacted Cancer National Service (CNS) and Acute Oncology Service (AOS) During First Year After Palbociclib Initiation CNS	36 Percentage of participants
Percentage of Participants Contacted Cancer National Service (CNS) and Acute Oncology Service (AOS) During First Year After Palbociclib Initiation AOS	19 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Palbociclib n=69 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Percentage of Participants According to Number of CNS Interactions 1	17 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 2	26 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 3	19 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 4	13 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 5	1 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 6	4 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 7	1 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 8	7 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 9	4 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 10	3 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 11	1 Percentage of participants
Percentage of Participants According to Number of CNS Interactions 14	1 Percentage of participants

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, "overall number of participants analyzed" signifies participants evaluable for this outcome measure.

Outcome measures

Measure	Palbociclib n=36 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Number of AOS Interactions Per Participant	2.1 Interactions per participant Standard Deviation 1.2

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could have more than one interaction.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Type of CNS and AOS Interactions CNS interactions: Phone call	124 Interactions
Type of CNS and AOS Interactions CNS interactions: Visit	133 Interactions
Type of CNS and AOS Interactions CNS interactions: Other	8 Interactions
Type of CNS and AOS Interactions AOS interactions: Phone call	49 Interactions
Type of CNS and AOS Interactions AOS interactions: Visit	25 Interactions

SECONDARY outcome

Timeframe: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)

Population: FAS comprised of medical records extracted for the purpose of the study from all eligible participants who were enrolled into the study. Here, one participant could have more than one event.

Outcome measures

Measure	Palbociclib n=191 Participants Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Reasons for CNS and AOS Interaction CNS interactions: Follow-up	157 Events
Reasons for CNS and AOS Interaction CNS interactions: General health and wellbeing check	2 Events
Reasons for CNS and AOS Interaction CNS interactions: Information about scans/appointments	2 Events
Reasons for CNS and AOS Interaction CNS interactions: Information about disease/treatment	44 Events
Reasons for CNS and AOS Interaction CNS interactions: Medical concerns	44 Events
Reasons for CNS and AOS Interaction CNS interactions: Psychological support	8 Events
Reasons for CNS and AOS Interaction CNS interactions: Admin issue	1 Events
Reasons for CNS and AOS Interaction CNS interactions: Clinical letter query	1 Events
Reasons for CNS and AOS Interaction CNS interactions: Computed tomographic of chest, abdomen and pelvis (CT CAP) query	1 Events
Reasons for CNS and AOS Interaction CNS interactions: Discussion about further dental work and denosumab injection	1 Events
Reasons for CNS and AOS Interaction CNS interactions: Not known	1 Events
Reasons for CNS and AOS Interaction CNS interactions: Pain issues	1 Events
Reasons for CNS and AOS Interaction CNS interactions: Scan/blood test	1 Events
Reasons for CNS and AOS Interaction CNS interactions: Treatment schedule	1 Events
Reasons for CNS and AOS Interaction AOS interactions: Follow-up	9 Events
Reasons for CNS and AOS Interaction AOS interactions: Information about disease/treatment	4 Events
Reasons for CNS and AOS Interaction AOS interactions: Inpatient admission	1 Events
Reasons for CNS and AOS Interaction AOS interactions: Medical concerns	60 Events

Adverse Events

Palbociclib

Serious events: 54 serious events

Other events: 116 other events

Deaths: 3 deaths

Serious adverse events

Measure	Palbociclib n=191 participants at risk Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Blood and lymphatic system disorders Neutropenia	27.7% 53/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).
Gastrointestinal disorders Diarrhoea	0.52% 1/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).
Gastrointestinal disorders Other	0.52% 1/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).

Other adverse events

Measure	Palbociclib n=191 participants at risk Participants with HR positive/HER2 negative MBC who received at least 1 dose of palbociclib as part of the IPP were observed during the study. Data was collected both retrospectively and prospectively, from participants' medical records for a maximum of 3 years following index date. Index date was defined as the palbociclib treatment initiation date.
Blood and lymphatic system disorders Neutropenia	47.1% 90/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).
Gastrointestinal disorders Diarrhoea	11.5% 22/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).
Gastrointestinal disorders Vomiting	6.8% 13/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).
Gastrointestinal disorders Nausea	12.6% 24/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).
Gastrointestinal disorders Other	9.4% 18/191 • From baseline up to maximum period of 3 years Same event may appear as both AE and SAE. But what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or participant may have both serious and non-serious event. AEs were reported as per participants' medical records. There was no specific medical dictionary. 6 participants had febrile neutropenia which was not recorded as SAE or non-SAE as associated grades were not collected as part of electronic case report form (eCRF).

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

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 publications 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.
• Publication restrictions are in place

Restriction type: OTHER