Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial

Recruiting Phase 3 Interventional Study
Anatomic Stage II Breast Cancer AJCC v8 Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage IIIC Breast Cancer AJCC v8 Estrogen Receptor-Positive Breast Carcinoma HER2-Negative Breast Carcinoma
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About This Trial
This phase III trial compares standard of care hormone therapy plus ribociclib to chemotherapy followed by hormone therapy plus ribociclib for the treatment of patients with high anatomic stage breast cancer with low risk of the cancer returning (low risk recurrence). Ribociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy, with letrozo…
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Eligibility Criteria
Inclusion Criteria: * STEP 0: Patient must be ≥ 18 years of age * STEP 0: Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 28 days prior to Step 0 pre-registration * STEP 0: Patient must be a postmenopausal woman or a man * NOTE: Menopause can be de…
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