Neoadj ph 2 AI Plus Everolimus in Postmenopausal Women w/ ER Pos/HER2 Neg, Low Risk Score

Summary

The purpose of this study is to see whether adding everolimus to hormone treatment before breast surgery will increase the chances of shrinking the breast cancer in those patients with hormone-responsive breast cancer and a lower Oncotype DX® Recurrence Score ( 25 or less), compared to prior experience with hormone therapy alone. Everolimus is a drug currently approved for use by the United States Food and Drug administration (FDA) for the treatment of patients with advanced or metastatic kidney or breast cancer. Everolimus is considered investigational for non-metastatic breast cancer patients.

Timeline

Start

2014-11-29

Primary completion

2021-03-01

Completion

2021-03-01

Outcome

Outcome not reported

Stopped (Enrollment): “Phase 2 of recruitment was contingent on 5 of 15 patients responding, which did not occur.”

Drugs

Indications