The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.
For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria
* Have a diagnosis of HR+, HER2- breast cancer
* Have locally advanced disease not amenable to curative treatment by surgery or metastatic disease. In addition, participants must fulfill 1 of the following criteria:
* relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
* relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression
* relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
* presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first line endocrine therapy for metastatic disease. Participants may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease
* for the endocrine naïve cohort: Must not have received prior endocrine therapy in current or prior disease setting
* Have postmenopausal status due to either surgical/natural menopause or ovarian suppression (initiated at least 28 days prior to Day 1 of Cycle 1) with a gonadotropin-releasing hormone (GnRH) agonist such as goserelin
* Have a negative serum pregnancy test at baseline (within 14 days prior to randomization) and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following the last dose of abemaciclib if postmenopausal status is due to ovarian suppression with a GnRH agonist
* Have either measurable disease or nonmeasurable bone only disease
* Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued previous therapies for cancer (including specifically, aromatase inhibitors, anti-estrogens, chemotherapy, radiotherapy, and immunotherapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (until the toxicity resolves to either baseline or at least Grade 1) except for residual alopecia or peripheral neuropathy
Exclusion Criteria
* 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 visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis visceral crisis is not the mere presence of visceral metastases but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of the disease
* Have clinical evidence or history of central nervous system metastasis
* Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, everolimus, or any CDK4/6 inhibitor. For the endocrine naïve cohort: In addition, have received treatment with any prior endocrine therapy
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days prior to randomization of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively
* Have received recent (within 28 days prior to randomization) yellow fever vaccination
* Have had major surgery within 14 days prior to randomization of study drug to allow for post-operative healing of the surgical wound and site(s)
* Have a personal history within the last 12 months of any of the following conditions: syncope of cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
* Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years
* Have received an autologous or allogeneic stem-cell transplant
* Have active bacterial or fungal infection, or detectable viral infection
* Have initiated bisphosphonates or approved Receptor activator of nuclear factor kappa-B (RANK) ligand targeted agents \<7 days prior to randomization
Primary outcome measure(s)
Progression-Free Survival (PFS) — From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months) PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (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 (146)
Facility
City
Region
Status
St. Bernards Medical Center
Jonesboro
Arkansas
Highlands Oncology Group
Springdale
Arkansas
University of California - San Diego
La Jolla
California
Kaiser Permanente
Riverside
California
Univ of California San Francisco
San Francisco
California
Stanford University Clinic
Stanford
California
Palm Beach Cancer Institue
Atlantis
Florida
Holy Cross Hospital
Fort Lauderdale
Florida
Florida Cancer Specialists - South
Fort Myers
Florida
Palm Beach Cancer Institue
Palm Beach Gardens
Florida
Florida Cancer Specialists - North
St. Petersburg
Florida
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa
Florida
Palm Beach Cancer Institue
Wellington
Florida
Palm Beach Cancer Institue
West Palm Beach
Florida
University Cancer & Blood Center, LLC
Athens
Georgia
Harbin Clinic
Rome
Georgia
Quincy Medical Group
Quincy
Illinois
Pharmasite Research, Inc.
Baltimore
Maryland
Dana Farber Cancer Institute
Boston
Massachusetts
Breslin Cancer Center
Lansing
Michigan
Minnesota Oncology/Hematology PA
Minneapolis
Minnesota
Washington University Medical School
City of Saint Peters
Missouri
Washington University Medical School
Creve Coeur
Missouri
Freeman Cancer Institute
Joplin
Missouri
St Lukes Hospital
Kansas City
Missouri
Washington University Medical School
St Louis
Missouri
Washington University Medical School
St Louis
Missouri
Billings Clinic
Billings
Montana
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
Icahn School of Medicine at Mount Sinai
New York
New York
Columbia University Medical Center
New York
New York
Rochester General Hospital
Rochester
New York
Rochester General Hospital
Rochester
New York
Novant Health, Oncology Research Institute
Winston-Salem
North Carolina
Oklahoma Cancer Specialists & Research Institute, LLC
Tulsa
Oklahoma
Sanford Research/USD
Sioux Falls
South Dakota
The Boston Baskin Cancer Group
Memphis
Tennessee
SMO Sarah Cannon Research Inst.
Nashville
Tennessee
Baylor College of Medicine
Houston
Texas
Oncology Consultants P.A.
Houston
Texas
+ 106 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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