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Clinical Trials in the UK / NCT03155997
Active, not recruiting Phase 3

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

NCT03155997 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 3
Started
2017-07-12
Last updated
2026-04-24

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

AbemaciclibStandard Adjuvant Endocrine Therapy

Abemaciclib: Administered orally.

Standard Adjuvant Endocrine Therapy: Administered according to label instructions.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (619)

FacilityCityRegionStatus
University of Alabama Birmingham Birmingham Alabama
Providence Alaska Medical Center Anchorage Alaska
Banner MD Anderson Cancer Center Gilbert Arizona
Arizona Oncology Associates, P.C. - HOPE Goodyear Arizona
St. Joseph's Hospital and Medical Center Phoenix Arizona
Mayo Clinic Hospital Phoenix Arizona
The University of Arizona Cancer Center Tucson Arizona
Yuma Regional Cancer Center Yuma Arizona
St. Bernards Medical Center Jonesboro Arkansas
Highlands Oncology Group Springdale Arkansas
Beverly Hills Cancer Center Beverly Hills California
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center Burbank California
City of Hope National Medical Center Duarte California
California Cancer Associates Research and Excellence Fresno California
Kaiser Permanente Harbor City California
Loma Linda University School of Medicine Loma Linda California
Cedars-Sinai Medical Center Los Angeles California
Pacific Cancer Care Monterey California
St. Joseph Hospital Orange California
University of California Davis (UC Davis) Comprehensive Cancer Center Sacramento California
UCSF Medical Center at Mission Bay San Francisco California
California Cancer Associates in Research and Excellence San Marcos California
Dignity Health Dominican Oncology and Hematology Santa Cruz California
Kaiser Permanente Vallejo California
USO-Rocky Mountain Cancer Center Boulder Colorado
USO-Rocky Mountain Cancer Center Thornton Colorado
Yale-New Haven Hospital New Haven Connecticut
Florida Cancer Specialists - South Fort Myers Florida
University of Florida College of Medicine Gainesville Florida
Millennium Oncology - Hollywood Hollywood Florida
Mayo Clinic in Florida Jacksonville Florida
Cancer Specialists of North Florida Jacksonville Florida
Florida Cancer Specialists - North Lecanto Florida
Ocala Oncology, P.A. Ocala Florida
Tallahassee Memorial Cancer Center Tallahassee Florida
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center Tampa Florida
University Cancer & Blood Center, LLC Athens Georgia
Northside Hospital Atlanta Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital Marietta Georgia
Summit Cancer Care DBA Candler Medical Oncology Practice Savannah Georgia

+ 579 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03155997 on ClinicalTrials.gov ↗ ← All trials in the UK