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

Official title

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 Less Than or Equal to 25 (OFSET)

Study identification

NCT ID

NCT05879926

Recruitment status

Recruiting

Study type

Interventional

Phase

Phase 3

Lead sponsor

NRG Oncology

Other

Enrollment

3,960 participants

Conditions and interventions

Eligibility (public fields only)

Age range

18 Years to 60 Years

Sex

Female

Healthy volunteers

Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date

Oct 17, 2023

Primary completion

Dec 31, 2031

Completion

Jun 30, 2034

Last update posted

May 6, 2026

2023 – 2034

United States locations

U.S. sites

1204

U.S. states

51

U.S. cities

797

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 34 non-U.S. sites.