SWOG-S1207 NSABP B-53

Closed to Accrual

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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

Status

Closed to Accrual

Date Opened To Accrual

September 3, 2013

Date Closed To Accrual

May 2, 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
The protocol and related documents are available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

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

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.


Patient Study Webpage

There is no available patient study webpage available for this trial at this time.