NRG-BR009

Open to Accrual

Return to Protocol Table

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score </= 25 (OFSET)

Principal Investigator

Eleftherios Mamounas, MD MPH

Status

Open to Accrual

Date Opened To Accrual

August 31, 2023


Disease Site

Breast [BR] Breast

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

Patient Population

<p “=””>Premenopausal patients with early-stage, HER2-negative breast cancer that is sensitive to hormones, and have an Oncotype DX Recurrence Score(R) equal to or less than 25.

Target Accrual

3960

Protocol Documents

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


Other

NRG-BR009, the OFSET Study Overview by Terry Mamounas, MD & Shannon Puhalla, MD  (July 2023)

NRG-BR009 Site-Directed Videos (posted August 2025):
– Study Overview Webinar
– Approaching Patients 
– Discussing NRG-BR009/OFSET
– NRG-BR009 Explaining a Randomized Trial

NRG-BR009 Physician-Focused Webinar (posted September 2025)

 

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.