Status:
ACTIVE_NOT_RECRUITING
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
Lead Sponsor:
Eli Lilly and Company
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT02246621
Start Date
November 6 2014
End Date
December 1 2025
Last Update
April 20 2025
Active Locations (155)
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1
Ironwood Cancer & Research Centers
Chandler, Arizona, United States, 85224
2
Highlands Oncology Group
Springdale, Arkansas, United States, 72762
3
CBCC Global Research, Inc.
Bakersfield, California, United States, 93309
4
California Cancer Associates Research and Excellence
Fresno, California, United States, 93720