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Clinical Trials in Australia / NCT02246621
Active, not recruiting Phase 3

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

NCT02246621 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2014-11-06
Last updated
2026-02-03

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Abemaciclib →Anastrozole →Letrozole →Placebo

Abemaciclib: Administered orally

Anastrozole: Administered orally

Letrozole: Administered orally

Placebo: Administered orally

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (155)

FacilityCityRegionStatus
Ironwood Cancer & Research Centers Chandler Arizona
Highlands Oncology Group Springdale Arkansas
CBCC Global Research, Inc. Bakersfield California
California Cancer Associates Research and Excellence Fresno California
TRIO-US (Translational Research in Oncology-US) Los Angeles California
Central Coast Medical Oncology Corporation Los Angeles California
Orlando Health, Inc Los Angeles California
North Valley Hematology/Oncology Medical Group Los Angeles California
UCLA Hematology/Oncology - Parkside Santa Monica California
Holy Cross Hospital Fort Lauderdale Florida
Lakes Research, LLC Miami Lakes Florida
Candler Medical Oncology Practice - Statesboro Savannah Georgia
Candler Medical Oncology Practice - Statesboro Savannah Georgia
Mayo Clinic in Rochester, Minnesota Rochester Minnesota
Nebraska Hematology-Oncology, P.C. Lincoln Nebraska
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
Mount Sinai Cancer Center New York New York
University of Tennessee Medical Center Knoxville Tennessee
Oncology Consultants P.A. Houston Texas
Joe Arrington Cancer Center Lubbock Texas
Chris O'Brien Lifehouse Camperdown New South Wales
St Vincent's Hospital Sydney New South Wales
Sydney Adventist Hospital Wahroonga New South Wales
Mater Adult Hospital Brisbane South Brisbane Queensland
Princess Alexandra Hospital Woolloongabba Queensland
The Queen Elizabeth Hospital Woodville South Australia
Barwon Health - The Geelong Hospital Geelong Victoria
St. John of God Murdoch Hospital Murdoch Western Australia
Medizinische Universität Wien Vienna State of Vienna
Universitaetsklinikum Allgemeines Krankenhaus Wien Vienna State of Vienna
Medizinische Universitaet Graz Graz Styria
Medizinische Universitaet Innsbruck Innsbruck Tyrol
Ordensklinikum Linz Linz Upper Austria
Iridium Kankernetwerk Wilrijk en Antwerp Wilrijk Antwerpen
Cliniques universitaires Saint-Luc Brussels Brussels Capital
Institut Jules Bordet Anderlecht Bruxelles-Capitale, Région de
Grand Hopital de Charleroi-Site Notre-Dame Charleroi Belgium
CHU UCL Namur/Site Sainte Elisabeth Namur Belgium
AZ Delta Roeselare Belgium
Cross Cancer Institute Edmonton Alberta

+ 115 more sites — see the full list on the official registry below.

On this site

📄 Verzenio (abemaciclib) drug profile →

More Eli Lilly and Company trials in Australia

Other trials for the same condition

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 NCT02246621 on ClinicalTrials.gov ↗ ← All trials in Australia