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Title:
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
Protocol Number:
NCTNS1207
Phase:
Phase III
Physician:
Antonio Wolff
Purpose:
This research is being done to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.
Eligibility:
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.
Treatment:
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.
Population:
Adult
Last Update
10/01/2014 04:03 AM
 

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