Stage IV Breast Cancer Clinical Trial
Official title:
Phase II Study of Everolimus Beyond Progression in Postmenopausal Women With Advanced, Hormone Receptor Positive Breast Cancer
This phase II trial studies how well everolimus and hormone therapy work in treating patients with hormone receptor positive breast cancer that has continued to spread (progressed) or returned after a period of improvement (recurred) on everolimus and exemestane hormone therapy. Everolimus is a chemotherapy drug that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen and progesterone are hormones that can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by lowering the amount of estrogen and progesterone the body makes. Giving everolimus with a different type of hormone therapy may be an effective treatment for breast cancer in patients who progressed on everolimus with exemestane.
PRIMARY OBJECTIVE: Progression free survival in patients with advanced or metastatic breast cancer receiving everolimus plus hormonal therapy beyond first progression. SECONDARY OBJECTIVES: 1. Clinical benefit rate (sum of stable disease, partial response, complete response). 2. Response rate (partial response and complete response). 3. Overall survival. 4. Safety, side effects and tolerability profile of everolimus. OUTLINE: Patients receive everolimus orally (PO) daily and a hormone therapy regimen chosen at the discretion of the investigator (anastrozole PO daily; letrozole PO daily; tamoxifen citrate PO daily; fulvestrant intramuscularly [IM] or PO on days 1, 15, and 29, and then monthly; megestrol acetate PO 4 times daily [QID]; or other regimen). Treatment continues in the absence of disease progression or unacceptable toxicity. ;
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