Trial Outcomes & Findings for Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer (NCT NCT02040857)

NCT ID: NCT02040857

Last Updated: 2025-04-29

Results Overview

The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 162 participants
• Primary outcome timeframe: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.
• Results posted on: 2025-04-29

Participant Flow

Participant milestones

Measure	Palbociclib With Adjuvant Endocrine Therapy Palbociclib: 125 mg PO qd 21 days on, 7 days off Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
Overall Study STARTED	162
Overall Study Treatment Discontinuation Evaluable	152
Overall Study COMPLETED	102
Overall Study NOT COMPLETED	60

Reasons for withdrawal

Measure	Palbociclib With Adjuvant Endocrine Therapy Palbociclib: 125 mg PO qd 21 days on, 7 days off Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
Overall Study Adverse Event	14
Overall Study Physician Decision	5
Overall Study Withdrawal by Subject	31
Overall Study patient non-compliance	3
Overall Study Lost to Follow-up	2
Overall Study recurrence	4
Overall Study ineligible	1

Baseline Characteristics

Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer

Baseline characteristics by cohort

Measure	Palbociclib With Adjuvant Endocrine Therapy n=162 Participants * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
Age, Customized Age, <50 years	69 Participants n=5 Participants
Age, Customized Age, >50 years	93 Participants n=5 Participants
Sex: Female, Male Female	157 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	144 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	162 participants n=5 Participants
Type of prior neo/adjuvant chemotherapy None	33 Participants n=5 Participants
Type of prior neo/adjuvant chemotherapy Neoadjuvant	60 Participants n=5 Participants
Type of prior neo/adjuvant chemotherapy Adjuvant	63 Participants n=5 Participants
Type of prior neo/adjuvant chemotherapy Both	4 Participants n=5 Participants
Type of prior neo/adjuvant chemotherapy Unknown	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.

Population: The analysis population is comprised of all uncensored participants.

The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in uncensored participants. Participants who discontinued palbociclib early for reasons that were not treatment-related were censored.

Outcome measures

Measure	Palbociclib With Adjuvant Endocrine Therapy n=152 Participants * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd	Tamoxifen + Palbociclib participants who received Tamoxifen as their endocrine therapy with Palbociclib
2-Year Treatment Discontinuation Rate	31 percentage of participants Interval 24.0 to 39.0	—

SECONDARY outcome

Timeframe: Evaluate upon completion of palbociclib, up to 2 years of treatment completion.

Population: The analysis population is comprised of all enrolled participants.

The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reason due to toxicity, withdrawal of consent to be treated, or other events related to tolerability of all enrolled participants.

Outcome measures

Measure	Palbociclib With Adjuvant Endocrine Therapy n=102 Participants * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd	Tamoxifen + Palbociclib n=60 Participants participants who received Tamoxifen as their endocrine therapy with Palbociclib
2-year Treatment Discontinuation Rate by Aromatase Inhibitor and Tamoxifen-based Therapy Subgroup	28 percentage of participants Interval 20.0 to 38.0	35 percentage of participants Interval 23.0 to 48.0

SECONDARY outcome

Timeframe: AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days.

Population: The analysis population is comprised of all enrolled participants.

Grade 3-4 treatment-related neutropenia toxicity rate is the percentage of participants experiencing at least one grade 3-4 neutropenia AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms.

Outcome measures

Measure	Palbociclib With Adjuvant Endocrine Therapy n=162 Participants * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd	Tamoxifen + Palbociclib participants who received Tamoxifen as their endocrine therapy with Palbociclib
Grade 3-4 Treatment-Related Neutropenia Toxicity Rate	54 percentage of participants Interval 46.0 to 62.0	—

SECONDARY outcome

Timeframe: AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days.

Population: The analysis population is comprised of all enrolled participants.

All grade treatment-related fatigue toxicity rate is the percentage of participants experiencing at least one grade 1-4 fatigue AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms.

Outcome measures

Measure	Palbociclib With Adjuvant Endocrine Therapy n=162 Participants * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd	Tamoxifen + Palbociclib participants who received Tamoxifen as their endocrine therapy with Palbociclib
All Grade Treatment-Related Fatigue Toxicity Rate	76 percentage of participants Interval 69.0 to 82.0	—

SECONDARY outcome

Timeframe: AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days.

Population: The analysis population is comprised of all enrolled participants.

All grade treatment-related alopecia toxicity rate is the percentage of participants experiencing at least one grade 1-4 alopecia AE with treatment attribution of possible, probable or definite based on NCI Common Toxicity Criteria for Adverse Events version 4 (CTCAEv4) during the time of observation on treatment as reported on case report forms.

Outcome measures

Measure	Palbociclib With Adjuvant Endocrine Therapy n=162 Participants * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd	Tamoxifen + Palbociclib participants who received Tamoxifen as their endocrine therapy with Palbociclib
All GradeTreatment-Related Alopecia Toxicity Rate	28 percentage of participants Interval 22.0 to 36.0	—

POST_HOC outcome

Timeframe: Evaluate upon completion of combination therapy with endocrine therapy plus palbociclib, up to 2 years of treatment completion.

Population: The analysis population is comprised of all enrolled participants.

The 2-year treatment discontinuation rate is the percentage of participants who do not complete the palbociclib treatment per protocol for reasons due to toxicity, withdrawal of consent to be treated, or other events related to tolerability in all enrolled participants.

Outcome measures

Measure	Palbociclib With Adjuvant Endocrine Therapy n=162 Participants * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd	Tamoxifen + Palbociclib participants who received Tamoxifen as their endocrine therapy with Palbociclib
Rate of Treatment Related Discontinuation	63 percentage of participants Interval 55.0 to 70.0	—

Adverse Events

Palbociclib With Adjuvant Endocrine Therapy

Serious events: 96 serious events

Other events: 162 other events

Deaths: 0 deaths

Serious adverse events

Measure	Palbociclib With Adjuvant Endocrine Therapy n=162 participants at risk * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
Cardiac disorders Cardiac disorders - Other, specify	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Mucositis oral	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	3.7% 6/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Breast infection	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Soft tissue infection	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Lymphocyte count decreased	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophil count decreased	48.1% 78/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Vascular disorders Hypertension	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Other adverse events

Measure	Palbociclib With Adjuvant Endocrine Therapy n=162 participants at risk * Palbociclib 125 mg PO qd 21 days on, 7 days off * Endocrine Therapy: Tamoxifen 20mg, Letrozole 2.5mg, Anastrozole 1mg, or Exemestane 25mg PO qd
Blood and lymphatic system disorders Anemia	25.9% 42/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Lymph node pain	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	1.9% 3/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Chest pain - cardiac	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Palpitations	4.3% 7/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Sinus bradycardia	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Sinus tachycardia	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Cardiac disorders Cardiac disorders - Other, specify	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Ear pain	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Tinnitus	2.5% 4/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Vertigo	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Vestibular disorder	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Ear and labyrinth disorders Ear and labyrinth disorders - Other, specify	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Dyspepsia	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Mucositis oral	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Chills	1.9% 3/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Edema limbs	5.6% 9/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	35.8% 58/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fever	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Flu like symptoms	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Localized edema	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Non-cardiac chest pain	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Pain	2.5% 4/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Bronchial infection	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Skin infection	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Neutrophil count decreased	2.5% 4/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Alopecia	1.2% 2/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Dry skin	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Pain of skin	0.62% 1/162 • AE data collected every cycle from the time of the first dose of study treatment, through the study and until 30 days after removal from study or death, whichever occurs first. Therefore, AEs were observed up to 2 years plus 30 days. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Additional Information

Project Manager

Dana-Farber Cancer Institute

Phone: 617-632-5313

Email: ctopm@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place