Trial · NCT03155997

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997, Phase 3, Active not recruiting, Eli Lilly and Company; results first posted 2021-04-09

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer. Trials, record NCT03155997. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03155997

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
NCT number: NCT03155997
Status: Active not recruiting
Phases: Phase 3
Enrollment: 5,637 participants, actual
Lead sponsor: Eli Lilly and Company
Conditions: Breast Cancer
Interventions: Abemaciclib, Standard Adjuvant Endocrine Therapy
First posted: 2017-05-16
Last updated: 2026-04-24
Other registries' IDs: eudract:2016-004362-26
Results first posted: 2021-04-09

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Invasive Disease Free Survival (IDFS)	Baseline to Recurrence or Death from Any Cause (Up to 32 Months)	IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
Secondary	IDFS for Participants With Ki-67 Index ≥20%	Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)	Outcome data will be provided after the study is completed.
Secondary	Distant Relapse-Free Survival (DRFS)	Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)	Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.
Secondary	Overall Survival (OS)	Baseline to Death from Any Cause (Approximately 10 Years)	Outcome data will be provided after the study is completed.
Secondary	Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib	Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose	Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib
Secondary	Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)	Baseline, Follow Up (Approximately 3 Years)	Outcome data will be provided after the study is completed.
Secondary	Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)	Baseline, Follow Up (Approximately 3 Years)]	Outcome data will be provided after the study is completed.
Secondary	Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Baseline, Follow Up (Approximately 3 Years)]	Outcome data will be provided after the study is completed.
Secondary	Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)	Baseline, Follow Up (Approximately 3 Years)]	Outcome data will be provided after the study is completed.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Invasive Disease Free Survival (IDFS)	Baseline to Recurrence or Death from Any Cause (Up to 32 Months)	All randomized participants (including the censored participants). 2672 participants were censored in 150 mg Abemaciclib + Endocrine Therapy, 2642 participants were censored in Endocrine Therapy.	Months	MEDIAN
SECONDARY	IDFS for Participants With Ki-67 Index ≥20%	Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)
SECONDARY	Distant Relapse-Free Survival (DRFS)	Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)	All randomized participants (including the censored participants). 2702 participants were censored in 150 mg Abemaciclib + Endocrine Therapy, 2677 participants were censored in Endocrine Therapy.	Months	MEDIAN
SECONDARY	Overall Survival (OS)	Baseline to Death from Any Cause (Approximately 10 Years)
SECONDARY	Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib	Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose	All randomized participants who received at least one dose of Abemaciclib and had evaluable PK data.	Nanograms per milliliter (ng/mL)	GEOMETRIC_MEAN
SECONDARY	Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)	Baseline, Follow Up (Approximately 3 Years)
SECONDARY	Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)	Baseline, Follow Up (Approximately 3 Years)]
SECONDARY	Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Baseline, Follow Up (Approximately 3 Years)]
SECONDARY	Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)	Baseline, Follow Up (Approximately 3 Years)]

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Invasive Disease Free Survival (IDFS)	150 mg Abemaciclib + Endocrine Therapy	NA	95% Confidence Interval NA to NA	Months
Invasive Disease Free Survival (IDFS)	Endocrine Therapy	NA	95% Confidence Interval NA to NA	Months
Distant Relapse-Free Survival (DRFS)	150 mg Abemaciclib + Endocrine Therapy	NA	95% Confidence Interval NA to NA	Months
Distant Relapse-Free Survival (DRFS)	Endocrine Therapy	NA	95% Confidence Interval NA to NA	Months
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib	150 mg Abemaciclib + Endocrine Therapy	143	Geometric Coefficient of Variation 110	Nanograms per milliliter (ng/mL)

Source ClinicalTrials.gov

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	150 mg Abemaciclib + Endocrine Therapy	2,808
Overall Study	STARTED	Endocrine Therapy	2,829
Overall Study	Received at Least One Dose of Study Drug	150 mg Abemaciclib + Endocrine Therapy	2,791
Overall Study	Received at Least One Dose of Study Drug	Endocrine Therapy	2,800
Overall Study	COMPLETED	150 mg Abemaciclib + Endocrine Therapy	650
Overall Study	COMPLETED	Endocrine Therapy	607
Overall Study	NOT COMPLETED	150 mg Abemaciclib + Endocrine Therapy	2,158
Overall Study	NOT COMPLETED	Endocrine Therapy	2,222

Source ClinicalTrials.gov

Adverse events848

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	150 mg Abemaciclib + Endocrine Therapy	634	2,791	862
other	Anaemia	Blood and lymphatic system disorders	Endocrine Therapy	88	2,800	113
other	Leukopenia	Blood and lymphatic system disorders	150 mg Abemaciclib + Endocrine Therapy	1,026	2,791	1,706
other	Leukopenia	Blood and lymphatic system disorders	Endocrine Therapy	171	2,800	244
other	Lymphopenia	Blood and lymphatic system disorders	150 mg Abemaciclib + Endocrine Therapy	372	2,791	527
other	Lymphopenia	Blood and lymphatic system disorders	Endocrine Therapy	94	2,800	118
other	Neutropenia	Blood and lymphatic system disorders	150 mg Abemaciclib + Endocrine Therapy	1,246	2,791	2,316
other	Neutropenia	Blood and lymphatic system disorders	Endocrine Therapy	140	2,800	214
other	Thrombocytopenia	Blood and lymphatic system disorders	150 mg Abemaciclib + Endocrine Therapy	341	2,791	528
other	Thrombocytopenia	Blood and lymphatic system disorders	Endocrine Therapy	39	2,800	48

1 to 10 of 848Source ClinicalTrials.gov

See all 848 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	150 mg Abemaciclib + Endocrine Therapy	38	2,791
Total, all-cause mortality	Endocrine Therapy	36	2,800
Total, other adverse events	150 mg Abemaciclib + Endocrine Therapy	2,723	2,791
Total, other adverse events	Endocrine Therapy	2,318	2,800
Total, serious adverse events	150 mg Abemaciclib + Endocrine Therapy	344	2,791
Total, serious adverse events	Endocrine Therapy	202	2,800

Source ClinicalTrials.gov

Papers13

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32954927	DERIVED	PubMed
35084948	DERIVED	PubMed
35337972	DERIVED	PubMed
35384873	DERIVED	PubMed
35594464	DERIVED	PubMed
35653145	DERIVED	PubMed
36342342	DERIVED	PubMed
36493792	DERIVED	PubMed
37735004	DERIVED	PubMed
38194616	DERIVED	PubMed

1 to 10 of 13

See all 13 papers

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
150 mg Abemaciclib + Endocrine Therapy vs Endocrine Therapy: deaths from any cause	Trial comparisons
150 mg Abemaciclib + Endocrine Therapy vs Endocrine Therapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03155997

GET https://conductscience.org/api/trials/v1/NCT03155997/events?page=2

API reference For AI assistants