SWOG 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.
e^3 Breast Cancer Study-Evaluating Everolimus with Endocrine Therapy.
This study is for patients with invasive breast cancer that is hormone receptor-positive, HER2-negative, has completed surgery and chemotherapy, and is considered high-risk for the breast cancer to return.
The purpose of this study is to test whether adding the drug everolimus (Afinitor) for one year to standard adjuvant endocrine therapy can delay the spread of cancer or recurrence of cancer in high-risk patients with Hormone Receptor-Positive, HER2-negative breast cancer.
Patients will be followed for 10 years after registration into the study.