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NCT05879926 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Breast Cancer, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 3,960
- Enrollment target
- 20
- Study locations
NCT05879926: Recruiting Phase 3 study of Breast Cancer, sponsored by NRG Oncology.
NCT05879926 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 3,960 participants, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (41% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05879926, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 3,960 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Time from randomization to the first diagnosis of local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause prior to recurrence or contralateral breast cancer.
Conditions Studied
Interventions
- DRUG Ovarian Function Suppression + Aromatase Inhibitor
- DRUG Adjuvant Chemotherapy + Ovarian Function Suppression
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- CARTI Cancer Center - Little Rock
- University of Arkansas for Medical Sciences - Little Rock
California
- Kaiser Permanente-Anaheim - Anaheim
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- PCR Oncology - Arroyo Grande
Arizona
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Mayo Clinic Hospital in Arizona - Phoenix
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,960 participants |
| Start Date | 2023-08-31 |
| Est. Completion | 2034-07 |
| Phase | Phase 3 |
What NCT05879926 shows while recruiting
NCT05879926 is an interventional study that assigns participants to a tested intervention. Its 3,960 participants enrollment target places it among the larger protocols in the corpus, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (41% higher).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Ovarian Function Suppression + Aromatase Inhibitor is the first listed.
NCT05879926 names 20 study sites across 5 states, led by Alaska, Arkansas, California.
Frequently Asked Questions
What is clinical trial NCT05879926 about?
NCT05879926 is a clinical study titled "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". 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 est...
What is the current status of trial NCT05879926?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 3,960 participants. The study started on 2023-08-31. Estimated completion is 2034-07.
What conditions does trial NCT05879926 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT05879926?
The interventions under investigation include: Ovarian Function Suppression + Aromatase Inhibitor (DRUG), Adjuvant Chemotherapy + Ovarian Function Suppression (DRUG).
Who is sponsoring clinical trial NCT05879926?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05879926 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05879926's enrollment target sits among peer trials
3,960 39th of 1224 higher than 1,186 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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