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
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This study is being done to answer the following question: Will the chance of your breast cancer returning be less if chemotherapy is added to hormonal therapy with an aromatase inhibitor and ovarian suppression? We are doing this study because we want to find out if this approach is better or worse as the other usual approach for your early-stage breast cancer that is sensitive to hormones, is HER2-negative, and is at higher risk for cancer returning. The usual approach for patients who are not in a study is treatment with surgery, radiation therapy, hormonal therapy, ovarian suppression, and sometimes chemotherapy using drugs approved by the Food and Drug Administration (FDA). For patients who get the usual approach for this cancer, about 93 out of 100 are free of cancer after 5 years.
Are you Eligible? (Inclusion Criteria)
- Are you 18 years of age or older and are not yet menopausal? Have you been diagnosed with early-stage breast cancer that is sensitive to hormones and is HER2-negative? Are you able to make regularly scheduled visits to the clinic for treatment and examinations?