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

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 sto

Trial Details

NCT ID
NCT07391774
Phase
PHASE3
Sponsor
National Cancer Institute (NCI)
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Anastrozole
  • Biospecimen Collection
  • Bone Scan
  • Chemotherapy
  • Computed Tomography
  • Exemestane
Locations (sample)
  • Bloomington, Illinois, United States|40.4842,-88.99369
  • Canton, Illinois, United States|40.55809,-90.03512
  • Carthage, Illinois, United States|40.41643,-91.13625
  • Eureka, Illinois, United States|40.72143,-89.27286
  • Galesburg, Illinois, United States|40.94782,-90.37124

Key Eligibility 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 determined by any of the following:

For full eligibility, visit ClinicalTrials.gov.

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