S1207 Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu-Negative Breast Cancer
This research is being done to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.
Generally healthy women or men with ER and/or PR positive and HER2 negative breast cancer who plan to get endocrine therapy may be eligible. In addition, the following will be required: No metastatic disease, Completed surgery with negative margins, Completed axillary staging, Completed chemotherapy, Normal blood test results, and Not pregnant or nursing.
Consented and eligible women will take standard endocrine therapy for 5 years and blinded study drug each day by mouth for up to 1 year. The study drug will either be everolimus or placebo (an inactive pill). The participant, study doctor, and study team will not know which one. Subjects will return to clinic every 6-12 weeks while receiving the blinded study drug and then standard follow-up for up to 5 years.
05/22/2015 04:01 AM