Metastatic Breast Cancer (MBC) Clinical Trial
Official title:
Phase I/II Trial of Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC)
The purpose of this study is to test the safety and effectiveness of the investigational drug, palbociclib with bicalutamide for the treatment of triple negative, androgen receptor positive breast cancer.
The study therapy is to be self administered on an outpatient basis. Patients who meet eligibility criteria and sign informed consent to Step 2 may begin treatment on study. Treatment consists of bicalutamide orally once daily and palbociclib will be given orally daily for 3 weeks on followed by 1 week off. A treatment cycle is considered to be 4 weeks. Eligible patients will be evaluated for toxicity every 2 weeks during Cycle #1 and 2, followed by every 4 weeks in subsequent cycles. Toxicity assessment will include history, physical examination including vital signs, and laboratories including complete blood count and comprehensive metabolic panel. Patients will keep a drug diary to document adherence to oral therapy. Radiographic response evaluation per RECIST will occur every 8 weeks (2 cycles) for cycles 1-6 and then every 12 weeks thereafter with high-resolution CT scan. Patients with suspected bone-only lesions must have bone lesions assessed by CT with bone windows or by bone scan at screening. Phase I: We will use a standard 3+3 design for the dose finding lead in to establish the recommended phase II doses for the combination of palbociclib and bicalutamide. The doses for Phase I will be determined based on the dose level to which the patient is accrued. Phase II: Treatment consists of bicalutamide orally once daily and palbociclib will be given orally daily for 3 weeks on followed by 1 week off at the doses determined in phase I. ;
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