NRG-BR009 - 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 Less Than or Equal to 25 (OFSET)

NCT#:	NCT05879926
NCT QR Code
Title:	NRG-BR009 – 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 Less Than or Equal to 25 (OFSET)
Protocol:	NRG-BR009
Cancer Type:	Breast
Study Sponsor:	NRG Oncology
Brief Summary:	This Phase III Trial will 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).
Study Type:	Intervention
Date Opened at SVH:	March 12, 2024
Recruitment Status:	Recruiting
Study Population:	See SCHEMA
Eligibility Criteria:	See SCHEMA
Principal Investigators:	Geetha N. Varma, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701 Hong Zhao, MD, Oncology, Salinas Valley Health Cancer Care, (831) 755-1701
Participating Institution:	Salinas Valley Health
Salinas Valley Health Clinical Research Program:	Terri Nielsen, MSJ, RN, CCRP, Clinical Research Program Manager, [email protected]
Link to ClinicalTrials.gov	https://clinicaltrials.gov/study/NCT05879926?term=NCT05879926&limit=10&rank=1
Summary	See Physician Material See Patient-facing Material