Meir Medical Center | Gynecology and Obstetrics Department
Status and phase
Conditions
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Study type
Funder types
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About
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK4/6 inhibitor and endocrine therapy. Participation could last up to 5 years, depending on how you and your tumor respond.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
Have radiologic evidence of disease progression or recurrence either
Must be deemed appropriate for treatment with ET
If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
Have Response Evaluable Criteria in Solid Tumors (RECIST) evaluable disease (measurable disease and/or nonmeasurable disease)
Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
Have adequate renal, hematologic, and hepatic organ function
Must be able to swallow capsules/tablets
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
368 participants in 2 patient groups
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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