PrE0102 Randomized, Double-Blind, Placebo-Controlled Phase II Trial of Fulvestrant (Faslodex) plus Everolimus in Post-Menopausal Patients with Hormone-Receptor Positive Metastatic Breast Cancer Resistant to Aromatase Inhibitor Therapy
To assess progression-free survival in post-menopausal patients with hormone-receptor positive metastatic breast cancer that is resistant to aromatase inhibitor therapy treated with fulvestrant and everolimus compared to fulvestrant alone.
Generally healthy, post-menopausal women with metastatic breast cancer with the following may be eligible to participate: previously taken an aromatase inhibitor that did not improve their disease, has not received more than one chemotherapy regimen for their metastatic disease, normal blood test results, has not received prior treatment with an mTOR inhibitor, is not receiving steroid therapy (excluding topical or inhaled steroids), has recovered from surgery, is not receiving an investigational agent, chemotherapy, radiation therapy or other therapy unless they are stopped before going on study, no significant medical condition as assessed that would prevent participating on this study.
Eligible candidates will either receive chemotherapy with everolimus or chemotherapy with a placebo (an inactive substance). Everolimus or its matching placebo will be taken by mouth once a day while receiving chemotherapy. Chemotherapy will be an injection of fulvestrant once a month for 12 months. The status of your cancer will be checked at least every 3 months. If you continue to due well and your cancer has not gotten worse after 12 months, you may continue to receive the same study regimen. After completing your study regimen, we will continue to follow you to see how you are and check on your cancer. This will be done until it has been 3 years since you first started the study.
09/17/2014 04:03 AM