Trial Outcomes & Findings for Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer (NCT NCT03130439)

NCT ID: NCT03130439

Last Updated: 2025-06-24

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

2 years

Results posted on

2025-06-24

Participant Flow

Participant milestones

Participant milestones
Measure	Abemaciclib -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Overall Study STARTED	27
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib n=27 Participants -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Age, Continuous	61 years n=5 Participants
Age, Customized Age at enrollment · Less than 50 years old	5 Participants n=5 Participants
Age, Customized Age at enrollment · Over 50 years old	22 Participants n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	24 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	2 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=5 Participants
Number of metastatic sites	7 sites n=5 Participants
Number of prior lines of systemic therapy for metastatic disease 0	2 Participants n=5 Participants
Number of prior lines of systemic therapy for metastatic disease 1	4 Participants n=5 Participants
Number of prior lines of systemic therapy for metastatic disease 2	14 Participants n=5 Participants
Number of prior lines of systemic therapy for metastatic disease 3	7 Participants n=5 Participants
(Neo)adjuvant therapy Yes	22 Participants n=5 Participants
(Neo)adjuvant therapy No	5 Participants n=5 Participants
Number of patients recurred within 12 months of their adjuvant systemic therapy	15 Participants n=5 Participants
Prior chemotherapies in any setting Anthracycline	18 participants n=5 Participants
Prior chemotherapies in any setting Taxane	22 participants n=5 Participants
Prior chemotherapies in any setting Eribulin	4 participants n=5 Participants
Prior immune therapy for early stage or metastatic disease	12 Participants n=5 Participants
BRCA1 or BRCA2 Mutation Present	4 Participants n=5 Participants
BRCA1 or BRCA2 Mutation Absent	19 Participants n=5 Participants
BRCA1 or BRCA2 Mutation Not reported	4 Participants n=5 Participants
Site of metastasis --Lung	12 Participants n=5 Participants
Site of metastasis --Liver	8 Participants n=5 Participants
Site of metastasis --Bone	15 Participants n=5 Participants
Site of metastasis --Brain	6 Participants n=5 Participants
Site of metastasis --Skin	10 Participants n=5 Participants
Site of metastasis --Lymph node	23 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Abemaciclib n=27 Participants -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Objective Response Rate	0 Participants

SECONDARY outcome

Timeframe: Baseline to the earlier of progression (per Response Evaluation Criteria in Solid Tumors 1.1), date of death due to any cause, or date of last disease evaluation. Participants will be followed up up to 16.5 months.

Progression-Free Survival (PFS) is defined as the time from randomization (or registration) to the earlier of progression (per Response Evaluation Criteria in Solid Tumors 1.1) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Abemaciclib n=27 Participants -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Progression Free Survival	1.94 months Interval 1.84 to 11.47

SECONDARY outcome

Timeframe: Baseline to date of death due to any cause, or at date last known alive.Participants will be followed once every 6 months until death.Those removed from protocol therapy for unacceptable adverse event(s) will be followed until resolution or stabilization.

Overall Survival (OS) is defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive.

Outcome measures

Outcome measures
Measure	Abemaciclib n=27 Participants -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Overall Survival	8.44 months Interval 4.57 to 15.57

SECONDARY outcome

Timeframe: 2 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD); Disease control rate is defined as CR + PR + SD ≥ 16weeks

Outcome measures

Outcome measures
Measure	Abemaciclib n=27 Participants -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Disease Control Rate	6 Participants

SECONDARY outcome

Timeframe: 2 years

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), Neither sufficient shrinkage (compared to baseline) to qualify for partial or complete response (CR or PR) nor sufficient increase (taking as reference the smallest sum of diameters at baseline or while on study, whichever is smallest) to qualify for progressive disease (PD); Clinical benefit rate is defined as CR+PR+SD ≥ 24weeks

Outcome measures

Outcome measures
Measure	Abemaciclib n=27 Participants -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Clinical Benefit Rate	4 Participants

Adverse Events

Abemaciclib

Serious events: 10 serious events

Other events: 27 other events

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Abemaciclib n=27 participants at risk -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Gastrointestinal disorders Abdominal pain	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Blood and lymphatic system disorders Anemia	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Bloating	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Blood bilirubin increased	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Colonic obstruction	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Constipation	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Respiratory, thoracic and mediastinal disorders Cough	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Dehydration	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Psychiatric disorders Depression	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Diarrhea	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
General disorders Fatigue	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Musculoskeletal and connective tissue disorders Flank pain	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Hyponatremia	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Nausea	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Neutrophil count decreased	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Cardiac disorders Pericardial effusion	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Platelet count decreased	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Infections and infestations Urinary tract infection	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Vomiting	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Alanine aminotransferase increased	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Anorexia	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Aspartate aminotransferase increased	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Musculoskeletal and connective tissue disorders Back pain	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Cardiac disorders Chest pain-cardiac	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Psychiatric disorders Confusion	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Hypokalemia	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
General disorders Pain	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Nervous system disorders Presyncope	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Cardiac disorders Sinus tachycardia	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Nervous system disorders Dizziness	3.7% 1/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.

Other adverse events

Other adverse events
Measure	Abemaciclib n=27 participants at risk -Abemaciclib was administered orally, twice daily on days 1 to 28 Abemaciclib: Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
Blood and lymphatic system disorders Anemia	33.3% 9/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Abdominal pain	25.9% 7/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Bloating	14.8% 4/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Constipation	33.3% 9/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Diarrhea	77.8% 21/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Dyspepsia	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Flatulence	14.8% 4/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Gastroesophageal reflux disease	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Mucositis oral	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Nausea	55.6% 15/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Stomach pain	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Vomiting	44.4% 12/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
General disorders Edema limbs	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
General disorders Fatigue	70.4% 19/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
General disorders Gait disturbance	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
General disorders Pain	18.5% 5/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Creatinine increased	18.5% 5/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Neutrophil count decreased	44.4% 12/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Investigations Platelet count decreased	29.6% 8/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Anorexia	40.7% 11/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Dehydration	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Hypokalemia	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Musculoskeletal and connective tissue disorders Back pain	18.5% 5/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Musculoskeletal and connective tissue disorders Neck pain	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Nervous system disorders Dizziness	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Nervous system disorders Dysgeusia	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Nervous system disorders Headache	22.2% 6/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Nervous system disorders Presyncope	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Psychiatric disorders Anxiety	18.5% 5/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Psychiatric disorders Depression	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Respiratory, thoracic and mediastinal disorders Cough	14.8% 4/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	18.5% 5/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Respiratory, thoracic and mediastinal disorders Pneumonitis	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Gastrointestinal disorders Oral pain	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Metabolism and nutrition disorders Hyponatremia	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Musculoskeletal and connective tissue disorders Bone pain	11.1% 3/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Nervous system disorders Peripheral sensory neuropathy	25.9% 7/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.
Blood and lymphatic system disorders Lymph node pain	7.4% 2/27 • 4.1 years Serious Adverse Events were defined as Grade 2/3 unexpected events with treatment attribution of possibly/probably/definitely, Grade 4 unexpected events with treatment attribution of possibly/probably/definitely and all Grade 5 events. 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.

Additional Information

Sara Tolaney, MD, MPH

Dana-Farber Cancer Institute

Phone: 617-632-5743

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place