A Phase III Adjuvant Trial 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 25

Sponsor:

NRG

Sponsor Study ID:

NRG-BR009

CTO #:

103985

NCT Number:

NCT05879926

Phase:

III

Protocol Type:

Treatment

Age Group:

Adults

Disease Sites:

Breast

Study Objectives:

To 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).

eConsent:

Not available

Study Documents:

Open Study Documents
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