A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

Key facts

Study ID: NCT02246621
Run by: Eli Lilly and Company
People needed: 493
Starts: 2014-11-06
Expected to finish: 2026-12-01
Last updated by the study team: 2026-02-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
Have postmenopausal status
Have either measurable disease or nonmeasurable bone-only disease
Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
Have adequate organ function
Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
Are able to swallow capsules

You may not qualify if…

Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
Have inflammatory breast cancer
Have clinical evidence or a history of central nervous system (CNS) metastasis
Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment
Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
Have received prior treatment with everolimus
Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
Have had major surgery within 14 days prior to randomization

Where it is running

Highlands Oncology Group — Springdale, Arkansas, United States
CBCC Global Research, Inc. — Bakersfield, California, United States
California Cancer Associates Research and Excellence — Fresno, California, United States
TRIO-US (Translational Research in Oncology-US) — Los Angeles, California, United States
Central Coast Medical Oncology Corporation — Los Angeles, California, United States
Orlando Health, Inc — Los Angeles, California, United States
North Valley Hematology/Oncology Medical Group — Los Angeles, California, United States
UCLA Hematology/Oncology - Parkside — Santa Monica, California, United States
Holy Cross Hospital — Fort Lauderdale, Florida, United States
Lakes Research, LLC — Miami Lakes, Florida, United States
Candler Medical Oncology Practice - Statesboro — Savannah, Georgia, United States
Candler Medical Oncology Practice - Statesboro — Savannah, Georgia, United States
Mayo Clinic in Rochester, Minnesota — Rochester, Minnesota, United States
Nebraska Hematology-Oncology, P.C. — Lincoln, Nebraska, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
Mount Sinai Cancer Center — New York, New York, United States
University of Tennessee Medical Center — Knoxville, Tennessee, United States
Oncology Consultants P.A. — Houston, Texas, United States
Joe Arrington Cancer Center — Lubbock, Texas, United States
Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
St Vincent's Hospital — Sydney, New South Wales, Australia
Sydney Adventist Hospital — Wahroonga, New South Wales, Australia
Mater Adult Hospital Brisbane — South Brisbane, Queensland, Australia
Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
Ironwood Cancer & Research Centers — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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