Condition(s):Breast Neoplasm, Neoplasm Metastasis
Principal Investigator:Jeselsohn, Rinath, Malka
Site Research Nurse(s):Abraham, Elizabeth,
Brule, Maurice, N.
Fleming, Norah, Michelle
Freeman, Stefani, Danielle
Hixon, Nicole, R.
Roche, Kathleen, A.
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.
- Have a diagnosis of HR+, HER2- locally advanced or metastatic breast cancer
- Have radiologic evidence of disease progression or recurrence either
- On treatment with a CDK4/6 inhibitor with aromatase inhibitor (AI) as initial
therapy for advanced disease, or
- On/after treatment with a CDK4/6 inhibitor plus endocrine therapy (ET)
administered as adjuvant therapy for early stage breast cancer
- Must be deemed appropriate for treatment with ET
- If female, have a postmenopausal status by natural or surgical means or by ovarian
- 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
- Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
- Have symptomatic or untreated central nervous system metastasis
- Have received any systemic therapy between disease recurrence/progression and study
- Have received more than 1 line of therapy for advanced or metastatic disease.
- Have received prior chemotherapy for metastatic breast cancer (MBC)
- Have received prior treatment with fulvestrant, any investigational estrogen receptor
(ER)-directed therapy (including selective ER degraders [SERDs] and non-SERDs), any
phosphatidylinositol 3-kinase (PI3K)-, mammalian target of rapamycin (mTOR)-, or
protein kinase B (AKT)-inhibitor
Protocol #: 22-170