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)
Progression Free Survival (PFS) — Randomization to Progressive Disease or Death Due to Any Cause (Up to 32 Months) PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
Trial sites (155)
Facility
City
Region
Status
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.
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.
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