Clinical trialNCT05879926RecruitingPhase 3Interventional

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

SponsorNRG OncologyEnrollment3,960Breast Cancer

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

clinicaltrials.gov ↗

Investigators

No overall officials are registered on this study record. Site-level investigators, where published, appear with their sites below. Why? →

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1,259 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Sara J. Rask
Recruiting
Waterloo Regional Health Network
Kitchener, Ontario, Canada
Nadia B. Califaretti
Recruiting
London Regional Cancer Program
London, Ontario, Canada
Veera Durga S. Panuganty
Recruiting
Oakville Trafalgar Memorial Hospital
Oakville, Ontario, Canada
Michael Herman
Recruiting
Lakeridge Health Oshawa
Oshawa, Ontario, Canada
Gursimran Chandhoke
Recruiting
Odette Cancer Centre- Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Carlos A. Carmona Gonzalez
Recruiting
Chum - Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
Saima Hassan
Recruiting
Jewish General Hospital
Montreal, Quebec, Canada
Parvaneh Fallah
Recruiting
Chu de Quebec-Hopital Du Saint-Sacrement (hss)
Québec, Quebec, Canada
Christine Desbiens
Recruiting
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont
Sherbrooke, Quebec, Canada
Michel Pavic
Recruiting
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
Haji I. Chalchal
Recruiting
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Shahid Ahmed
Recruiting

Colombia

Instituto Nacional de Cancerologia
Bogotá, Colombia
Suspended

Japan

Ehime University Hospital
Tōon, Ehime, Japan
Yoshiaki Kamei
Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Tomohiro Oshino
Recruiting
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Koji Matsumoto
Recruiting
Gunma University Hospital
Gunma, Maebashi, Japan
Sayaka Obayashi
Recruiting
the Cancer Institute Hospital of Jfcr
Koto-ku, Tokyo, Japan
Yukinori Ozaki
Recruiting
Hiroshima University Hospital
Hiroshima, Japan
Hideo Shigematsu
Recruiting
Kyoto University Hospital
Kyoto, Japan
Norikazu Masuda
Recruiting
Shikoku Cancer Center
Matsuyama, Japan
Daisuke Takabatake
Recruiting
Okayama University Hospital
Okayama, Japan
Tadahiko Shien
Recruiting
Saitama Medical University International Medical Center
Saitama, Japan
Akihiro Fujimoto
Recruiting
Nagoya University Hospital
Showa-Ku Nagoya, Japan
Masayuki Nagahashi
Recruiting
National Cancer Center Hospital
Tokyo, Japan
Shin Takayama
Recruiting

Mexico

Instituto Nacional de Cancerologia de Mexico
Mexico City, Tlalpan, Mexico
Areli Velazquez Martinez
Recruiting

Peru

Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru
Suspended

Puerto Rico

Cancer Center-Metro Medical Center Bayamon
Bayamón, Puerto Rico
Luis J. Santos Reyes
Recruiting
Puerto Rico Hematology Oncology Group
Bayamón, Puerto Rico
Luis J. Santos Reyes
Recruiting
Doctors Cancer Center
Manati, Puerto Rico
Luis J. Santos Reyes
Recruiting
Centro Comprensivo de Cancer de Upr
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting
Proncology
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting
San Juan City Hospital
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting
San Juan Community Oncology Group
San Juan, Puerto Rico
Luis J. Santos Reyes
Recruiting

United States

University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Active, not recruiting
Alaska Breast Care and Surgery Llc
Anchorage, Alaska, United States
Dan S. Zuckerman
Recruiting
Alaska Oncology and Hematology Llc
Anchorage, Alaska, United States
Dan S. Zuckerman
Recruiting
Alaska Women'S Cancer Care
Anchorage, Alaska, United States
Dan S. Zuckerman
Recruiting
Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States
Dan S. Zuckerman
Recruiting
Anchorage Oncology Centre
Anchorage, Alaska, United States
Suspended

1,219 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Adjuvant Chemotherapy + Ovarian Function SuppressionOvarian Function Suppression + Aromatase Inhibitor

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 18 Oct 2023
Primary completion: 31 Jan 2032
Completion: 31 Jul 2034
Last update posted: 4 Aug 2026
Registered enrollment: 3,960
Registry id: NCT05879926

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.