RecruitingBreast Cancer

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

Eligible age

18–60 yrs

Accepts

Women

Locations

51 states

Healthy volunteers

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About this study

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).

Sponsor: NRG Oncology

You may qualify if…

✓ 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.
✓ Patients must be 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.

You may not qualify if…

✕ • 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.
✕ Life expectancy of less than 10 years due to co-morbid conditions in the opinion of the investigator.
✕ Known results from most recent lab studies obtained as part of routine care prior to study entry showing ANY of the following values:
✕ ANC (absolute neutrophil count) less than 1200/mm3;
✕ Platelet count less than 100,000/mm3;