Evaluative Everolimus with Endocrine Therapy
The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic (cancer that has spread) kidney or breast cancer. It is considered investigational for non-metastatic breast cancer patients.
In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.
In order to participate you must meet the following criteria:
- Have histologically documented HER2 negative and either ER or PR positive status.
- Have completed neoadjuvant or adjuvant chemotherapy prior to participation.
- Have high risk of recurrence.
You will be excluded from the study if any of the following criteria apply to you:
- Have stage IV (metastatic) breast cancer.
- Have known cardiac disease.
- Have positive margins or appropriate axillary staging after breast-conserving surgery or total mastectomy.
This is a partial list of inclusion and exclusion criteria.