NCT03155997 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: ACTIVE NOT RECRUITING
Registry last update: 2026-04-24

The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Invasive Disease Free Survival (IDFS)

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outcome · NOT POSTED

IDFS for Participants With Ki-67 Index ≥20%

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outcome · POSTED

Distant Relapse-Free Survival (DRFS)

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outcome · NOT POSTED

Overall Survival (OS)

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outcome · POSTED

Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

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outcome · NOT POSTED

Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)

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outcome · NOT POSTED

Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

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outcome · NOT POSTED

Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

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outcome · NOT POSTED

Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations). * The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases. * The participant must have undergone definitive surgery of the primary breast tumor. * The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization. * Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence: * 4 or more positive axillary lymph nodes * Tumor size of at least 5 centimeters * Grade 3 defined as at least 8 points on the Bloom Richardson grading system * Ki-67 index by central analysis of ≥20% on untreated breast tissue * The participant must be randomized within 16 months from the time of definitive breast cancer surgery. * The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last. * Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery. * Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods. * The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1. * The participant has adequate organ function. * The participant is able to swallow oral medications. Exclusion Criteria: * Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease. * Participants with inflammatory breast cancer. * Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded. * Females who are pregnant or lactating. * The participant has previously received treatment with any CDK4 and CDK6 inhibitor. * The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate). * The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene. * The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study. * The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE). * The participant has active systemic infections or viral load. * The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
intervention Names
Drug: Abemaciclib
Drug: Standard Adjuvant Endocrine Therapy
label
150 mg Abemaciclib + Endocrine Therapy
type
EXPERIMENTAL
description
Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
intervention Names
Drug: Standard Adjuvant Endocrine Therapy
label
Endocrine Therapy
type
OTHER

interventions

arm Group Labels
150 mg Abemaciclib + Endocrine Therapy
description
Administered orally.
name
Abemaciclib
other Names
LY2835219
type
DRUG
arm Group Labels
150 mg Abemaciclib + Endocrine Therapy
Endocrine Therapy
description
Administered according to label instructions.
name
Standard Adjuvant Endocrine Therapy
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 5637
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Invasive Disease Free Survival (IDFS)
time Frame
Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

secondary Outcomes

description
Outcome data will be provided after the study is completed.
measure
IDFS for Participants With Ki-67 Index ≥20%
time Frame
Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)
description
Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.
measure
Distant Relapse-Free Survival (DRFS)
time Frame
Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)
description
Outcome data will be provided after the study is completed.
measure
Overall Survival (OS)
time Frame
Baseline to Death from Any Cause (Approximately 10 Years)
description
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib
measure
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib
time Frame
Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose
description
Outcome data will be provided after the study is completed.
measure
Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)
time Frame
Baseline, Follow Up (Approximately 3 Years)
description
Outcome data will be provided after the study is completed.
measure
Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
time Frame
Baseline, Follow Up (Approximately 3 Years)]
description
Outcome data will be provided after the study is completed.
measure
Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
time Frame
Baseline, Follow Up (Approximately 3 Years)]
description
Outcome data will be provided after the study is completed.
measure
Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
time Frame
Baseline, Follow Up (Approximately 3 Years)]

Full study description

brief Summary: The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Source references

references

citation
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