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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 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.

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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).

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

FieldValue
Enrollment Target 3,960 participants
Start Date 2023-08-31
Est. Completion 2034-07
Phase Phase 3

Sponsor

NRG Oncology

64 total trials

What the Registry Record Tells You About NCT05879926

The ClinicalTrials.gov registry entry for NCT05879926 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 3,960 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 2,800-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (41% higher). The listed sponsor is NRG Oncology, which has 64 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.