Clinical Trial

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
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Summary
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 letrozole, anastrozole or exemestane, lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Hormone therapy plus ribociclib may work as well as chemotherapy followed by hormone therapy plus ribociclib for the treatment of high anatomic stage breast cancer with low recurrence risk.
Protocol Amendment History 15 changes
notable Trial sites expanded: 129 -> 132 locations 2026-08-12
notable Trial sites expanded: 125 -> 129 locations 2026-08-11
notable Trial sites expanded: 116 -> 123 locations 2026-08-07
notable Trial sites expanded: 72 -> 116 locations 2026-08-06
notable Trial sites expanded: 67 -> 72 locations 2026-07-23
notable Trial sites expanded: 64 -> 67 locations 2026-07-21
notable Trial sites expanded: 61 -> 64 locations 2026-07-19
notable Trial sites expanded: 56 -> 59 locations 2026-07-14
notable Trial sites expanded: 40 -> 54 locations 2026-07-10
notable Trial sites expanded: 36 -> 40 locations 2026-07-08
notable Trial sites expanded: 28 -> 36 locations 2026-07-03
notable Trial sites expanded: 25 -> 28 locations 2026-07-02
notable Trial sites expanded: 14 -> 18 locations 2026-06-12
critical Recruitment opened 2026-06-06
notable Trial sites expanded: 0 -> 14 locations 2026-06-06
Trial Details
NCT Number NCT07391774
Lead Sponsor National Cancer Institute (NCI)
Conditions 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
Enrollment 1,978 participants
Start Date 2026-08-10
Primary Completion 2029-07-31 (estimated)
Study Completion 2029-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-14