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 (OFSET)

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).

In order to participate you must meet the following criteria:

• Are a female patient and are at least 18 years of age.
• Are premenopausal (evidence of functioning ovaries) at the time of pre-entry.
  • For study purposes, premenopausal is defined as:
    • Age 50 years or under with spontaneous menses within 12 months; or
    • Age greater than 50-60 years with spontaneous menses within 12 months plus follicle-stimulating hormone (FSH) and estradiol levels in the premenopausal range; or
    • Patients with amenorrhea due to IUD or prior uterine ablation must have FSH and estradiol levels in the premenopausal range; or
    • Patients with prior hysterectomy must have FSH and estradiol levels in the premenopausal range.
• Have an ECOG performance status of less than or equal to 2.
• Patients may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy.

You will be excluded from the study if any of the following criteria apply to you:

• Have definitive clinical or radiologic evidence of metastatic disease.
• Are pregnant or lactating at the time of pre-entry.
• Have evidence of chronic hepatitis B virus (HBV) infection, unless the HBV viral load is undetectable on suppressive therapy.
• Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin/progesterone IUDs).

This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.