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 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).

Trial Details

NCT ID
NCT05879926
Phase
PHASE3
Sponsor
NRG Oncology
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Ovarian Function Suppression + Aromatase Inhibitor
  • Adjuvant Chemotherapy + Ovarian Function Suppression
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Anchorage, Alaska, United States|61.21806,-149.90028
  • Anchorage, Alaska, United States|61.21806,-149.90028

Key Eligibility Criteria

  • A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry and, for patients treated in the…
  • Female patients must be greater than or equal to 18 years of age.
  • Patients must be premenopausal (evidence of functioning ovaries) at the time of pre-entry. For study purposes, premenopausal is defined as:

For full eligibility, visit ClinicalTrials.gov.

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