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
This study is recruiting at 1,085 US sites in 49 states, according to its ClinicalTrials.gov record last updated .
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).
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 to 60 years
- Sex
- Female
- Healthy volunteers
- Not accepted
- Sponsor
- NRG Oncology
- Last updated on ClinicalTrials.gov
- September 2, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Alaska · 7
- Alaska Breast Care and Surgery LLC · Anchorage, AK
- Alaska Oncology and Hematology LLC · Anchorage, AK
- Alaska Women's Cancer Care · Anchorage, AK
- Anchorage Associates in Radiation Medicine · Anchorage, AK
- Katmai Oncology Group · Anchorage, AK
- Providence Alaska Medical Center · Anchorage, AK
- Fairbanks Memorial Hospital · Fairbanks, AK
Arizona · 3
- Kingman Regional Medical Center · Kingman, AZ
- Cancer Center at Saint Joseph's · Phoenix, AZ
- Mayo Clinic Hospital in Arizona · Phoenix, AZ
Arkansas · 5
- Mercy Hospital Fort Smith · Fort Smith, AR
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro · Jonesboro, AR
- Baptist Health Medical Center - Little Rock · Little Rock, AR
- CARTI Cancer Center · Little Rock, AR
- University of Arkansas for Medical Sciences · Little Rock, AR
California · 109
- Kaiser Permanente-Anaheim · Anaheim, CA
- Kaiser Permanente-Deer Valley Medical Center · Antioch, CA
- Mission Hope Medical Oncology - Arroyo Grande · Arroyo Grande, CA
- PCR Oncology · Arroyo Grande, CA
- Sutter Auburn Faith Hospital · Auburn, CA
- Sutter Cancer Centers Radiation Oncology Services-Auburn · Auburn, CA
- Kaiser Permanente-Baldwin Park · Baldwin Park, CA
- Kaiser Permanente-Bellflower · Bellflower, CA
- Alta Bates Summit Medical Center-Herrick Campus · Berkeley, CA
- Tower Cancer Research Foundation · Beverly Hills, CA
- Keck Medicine of USC Buena Park · Buena Park, CA
- Providence Saint Joseph Medical Center/Disney Family Cancer Center · Burbank, CA
- Mills-Peninsula Medical Center · Burlingame, CA
- Marshall Cancer Center · Cameron Park, CA
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park · Cameron Park, CA
- Mercy Cancer Center - Carmichael · Carmichael, CA
- Mercy San Juan Medical Center · Carmichael, CA
- Eden Hospital Medical Center · Castro Valley, CA
- Enloe Medical Center · Chico, CA
- Sutter Davis Hospital · Davis, CA
- Kaiser Permanente Dublin · Dublin, CA
- Mercy Cancer Center - Elk Grove · Elk Grove, CA
- Stanford Cancer Center Emeryville · Emeryville, CA
- Kaiser Permanente-Fontana · Fontana, CA
- Kaiser Permanente-Fremont · Fremont, CA
- Palo Alto Medical Foundation-Fremont · Fremont, CA
- Fresno Cancer Center · Fresno, CA
- Kaiser Permanente Fresno Orchard Plaza · Fresno, CA
- Kaiser Permanente-Fresno · Fresno, CA
- Kaiser Permanente South Bay · Harbor City, CA
- Kaiser Permanente-Irvine · Irvine, CA
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care · Irvine, CA
- Loma Linda University Medical Center · Loma Linda, CA
- Cedars-Sinai Medical Center · Los Angeles, CA
- Kaiser Permanente Los Angeles Medical Center · Los Angeles, CA
- Kaiser Permanente West Los Angeles · Los Angeles, CA
- The Angeles Clinic and Research Institute - West Los Angeles Office · Los Angeles, CA
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, CA
- Fremont - Rideout Cancer Center · Marysville, CA
- Mercy Cancer Center · Merced, CA
- Kaiser Permanente- Modesto MOB II · Modesto, CA
- Kaiser Permanente-Modesto · Modesto, CA
- Memorial Medical Center · Modesto, CA
- Palo Alto Medical Foundation-Camino Division · Mountain View, CA
- Palo Alto Medical Foundation-Gynecologic Oncology · Mountain View, CA
- Providence Queen of The Valley · Napa, CA
- Sutter Cancer Research Consortium · Novato, CA
- Kaiser Permanente Oakland-Broadway · Oakland, CA
- Kaiser Permanente-Oakland · Oakland, CA
- Kaiser Permanente-Ontario · Ontario, CA
- UC Irvine Health/Chao Family Comprehensive Cancer Center · Orange, CA
- Palo Alto Medical Foundation Health Care · Palo Alto, CA
- Stanford Cancer Institute Palo Alto · Palo Alto, CA
- Kaiser Permanente - Panorama City · Panorama City, CA
- Huntington Memorial Hospital · Pasadena, CA
- Keck Medical Center of USC Pasadena · Pasadena, CA
- Pomona Valley Hospital Medical Center · Pomona, CA
- Kaiser Permanente-Rancho Cordova Cancer Center · Rancho Cordova, CA
- Eisenhower Medical Center · Rancho Mirage, CA
- Kaiser Permanente- Marshall Medical Offices · Redwood City, CA
- Kaiser Permanente-Richmond · Richmond, CA
- Kaiser Permanente-Riverside · Riverside, CA
- Mercy Cancer Center - Rocklin · Rocklin, CA
- Rohnert Park Cancer Center · Rohnert Park, CA
- Kaiser Permanente-Roseville · Roseville, CA
- Sutter Cancer Centers Radiation Oncology Services-Roseville · Roseville, CA
- Sutter Roseville Medical Center · Roseville, CA
- The Permanente Medical Group-Roseville Radiation Oncology · Roseville, CA
- Kaiser Permanente Downtown Commons · Sacramento, CA
- Kaiser Permanente-South Sacramento · Sacramento, CA
- Mercy Cancer Center - Sacramento · Sacramento, CA
- South Sacramento Cancer Center · Sacramento, CA
- Sutter Medical Center Sacramento · Sacramento, CA
- University of California Davis Comprehensive Cancer Center · Sacramento, CA
- Salinas Valley Memorial · Salinas, CA
- Kaiser Permanente-Rio San Diego · San Diego, CA
- Kaiser Permanente-San Diego Zion · San Diego, CA
- California Pacific Medical Center-Pacific Campus · San Francisco, CA
- Kaiser Permanente-San Francisco · San Francisco, CA
- Kaiser Permanente-Santa Teresa-San Jose · San Jose, CA
- Stanford Cancer Center South Bay · San Jose, CA
- Kaiser Permanente San Leandro · San Leandro, CA
- Pacific Central Coast Health Center-San Luis Obispo · San Luis Obispo, CA
- Kaiser Permanente-San Marcos · San Marcos, CA
- Mills Health Center · San Mateo, CA
- Kaiser San Rafael-Gallinas · San Rafael, CA
- Ridley-Tree Cancer Center · Santa Barbara, CA
- Kaiser Permanente Medical Center - Santa Clara · Santa Clara, CA
- Palo Alto Medical Foundation-Santa Cruz · Santa Cruz, CA
- Santa Cruz Radiation Oncology Medical Group · Santa Cruz, CA
- Mission Hope Medical Oncology - Santa Maria · Santa Maria, CA
- Kaiser Permanente-Santa Rosa · Santa Rosa, CA
- Providence Medical Foundation - Santa Rosa · Santa Rosa, CA
- Providence Santa Rosa Memorial Hospital · Santa Rosa, CA
- Sutter Pacific Medical Foundation · Santa Rosa, CA
- Kaiser Permanente Cancer Treatment Center · South San Francisco, CA
- Kaiser Permanente-South San Francisco · South San Francisco, CA
- Kaiser Permanente-Stockton · Stockton, CA
- Saint Joseph's Medical Center · Stockton, CA
- Palo Alto Medical Foundation-Sunnyvale · Sunnyvale, CA
- Cedars-Sinai Cancer - Tarzana · Tarzana, CA
- Torrance Memorial Physician Network - Cancer Care · Torrance, CA
- Gene Upshaw Memorial Tahoe Forest Cancer Center · Truckee, CA
- Kaiser Permanente Medical Center-Vacaville · Vacaville, CA
- Kaiser Permanente-Vallejo · Vallejo, CA
- Sutter Solano Medical Center/Cancer Center · Vallejo, CA
- Kaiser Permanente-Walnut Creek · Walnut Creek, CA
- Woodland Memorial Hospital · Woodland, CA
- Kaiser Permanente-Woodland Hills · Woodland Hills, CA
Colorado · 21
- UCHealth University of Colorado Hospital · Aurora, CO
- Memorial Hospital North · Colorado Springs, CO
- Penrose-Saint Francis Healthcare · Colorado Springs, CO
- Rocky Mountain Cancer Centers-Penrose · Colorado Springs, CO
- Saint Francis Cancer Center · Colorado Springs, CO
- UCHealth Memorial Hospital Central · Colorado Springs, CO
- Saint Joseph Hospital - Cancer Centers of Colorado · Denver, CO
- UCHealth - Cherry Creek · Denver, CO
- Dillon Health Center/Shaw Cancer Center · Dillon, CO
- CommonSpirit Cancer Center Mercy · Durango, CO
- Mercy Medical Center · Durango, CO
- Shaw Cancer Center · Edwards, CO
- Lutheran Hospital - Cancer Centers of Colorado · Golden, CO
- National Jewish Health-Western Hematology Oncology · Golden, CO
- Saint Mary's Hospital and Regional Medical Center · Grand Junction, CO
- UCHealth Highlands Ranch Hospital · Highlands Ranch, CO
- CommonSpirit Saint Anthony Hospital Cancer Center · Lakewood, CO
- UCHealth Lone Tree Health Center · Lone Tree, CO
- Longmont United Hospital · Longmont, CO
- Saint Mary Corwin Medical Center · Pueblo, CO
- Saint Anthony North Hospital · Westminster, CO
Connecticut · 5
- Hartford HealthCare - Avon · Avon, CT
- Hartford HealthCare - Saint Vincent's Medical Center · Bridgeport, CT
- Danbury Hospital · Danbury, CT
- Smilow Cancer Hospital-Derby Care Center · Derby, CT
- Smilow Cancer Hospital Care Center-Fairfield · Fairfield, CT
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.