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 (NCT05879926)
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)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1259 Sites)
Showing the first 25 of 1259 sites.
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- Anchorage Associates in Radiation Medicine — Anchorage, Alaska
- Anchorage Radiation Therapy Center — Anchorage, Alaska
- Alaska Breast Care and Surgery LLC — Anchorage, Alaska
- Alaska Oncology and Hematology LLC — Anchorage, Alaska
- Alaska Women's Cancer Care — Anchorage, Alaska
- Anchorage Oncology Centre — Anchorage, Alaska
- Katmai Oncology Group — Anchorage, Alaska
- Providence Alaska Medical Center — Anchorage, Alaska
- Fairbanks Memorial Hospital — Fairbanks, Alaska
- Kingman Regional Medical Center — Kingman, Arizona
- Cancer Center at Saint Joseph's — Phoenix, Arizona
- Mayo Clinic Hospital in Arizona — Phoenix, Arizona
- Mercy Hospital Fort Smith — Fort Smith, Arkansas
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas
- Baptist Health Medical Center - Little Rock — Little Rock, Arkansas
- CARTI Cancer Center — Little Rock, Arkansas
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- Kaiser Permanente-Anaheim — Anaheim, California
- Kaiser Permanente-Deer Valley Medical Center — Antioch, California
- Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California
- PCR Oncology — Arroyo Grande, California
- Sutter Auburn Faith Hospital — Auburn, California
- Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California
- Kaiser Permanente-Baldwin Park — Baldwin Park, California
📞 Contact the Study Coordinator
Phone: (412) 339-5300
Email: langerj@nrgoncology.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.