S1207 - Hormone Therapy With or Without Everolimus in Treating Patients with Breast Cancer
The purpose of this study is to determine whether adding a year of everolimus to standard adjuvant hormonal therapy improves disease-free interval in patients with hormone-receptor-positive and HER2-negative breast cancer.
Eligible adult patients (either sex) have a diagnosis of breast cancer and have completed surgery, radiation therapy, and/or adjuvant or neoadjuvant chemotherapy and have no evidence of disease at time of study entry.
Patients with inflammatory breast cancer or metastatic disease, serious cardiac disease, uncontrolled diabetes, hepatitis, uncontrolled pulmonary disease, or impaired gastrointestinal function are not eligible.
Estimated Enrollment: 3500 patients from multiple cancer centers in the US.