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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)

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 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.

Eligibility criteria

Qualifiers

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

Prior bilateral oophorectomy

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Anastrozole
  • Biospecimen Collection
  • Bone Scan
  • Chemotherapy
  • Computed Tomography
  • Exemestane
  • Letrozole
  • Oncotype DX Breast Cancer Assay
  • Positron Emission Tomography
  • Ribociclib Succinate

Treatment groups

1,978 Participants
are divided into 2 treatment groups