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).
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 U.S., authorization permitting release of personal health information.
Female patients must be greater than or equal to 18 years of age.
Age 50 years or under with spontaneous menses within 12 months; or
• Definitive clinical or radiologic evidence of metastatic disease.
pT4 (pathological state) tumors, including inflammatory breast cancer.
History of ipsilateral or contralateral invasive breast cancer. (Patients with synchronous and/or previous DCIS or LCIS are eligible.)
If prior ipsilateral DCIS was treated with lumpectomy and XRT (ionizing radiation therapy), a mastectomy must have been performed for the current cancer.
NRG Oncology
Lead sponsor
National Cancer Institute (NCI)
Collaborator