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: e3 Breast Cancer Study - Evaluating Everolimus with Endocrine Therapy
Principal Investigator
Mariana Chavez-MacGregor, MD MSc
Status
Closed to Accrual
Date Opened To Accrual
September 03 2013
Date Closed to Accrual
May 02 2019
Disease Site
Breast [BR]
Breast
Phase
III
Developmental Therapeutics
No
Primary Objective
The primary objective of this study is to compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR) positive and HER2-negative breast cancer.
Protocol Documents
Note: This study is a collaboration between SWOG and NRG Oncology. SWOG is the lead organization.
Patient Population
Patients with histologically confirmed invasive breast carcinoma with positive ER and/or PgR status and negative HER-2, for whom standard adjuvant endocrine therapy is planned.
Target Accrual
1900
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.