NCT07391774|RecruitingPhase 3FDA Drug

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

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS≤25 (RxFINE-Low)

National Cancer Institute (NCI)ClinicalTrials.gov

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3 other identifiers

NCI-2026-00634EA1242U10CA180820

Study Type

interventional

Target

1,978

Locations

1 country

Sites

Timeline

RegisteredFeb 2026

StartedFeb 2027

CompletionJul 2029

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,978

participants targeted

Target at P75+ for phase_3

Timeline

30mo left

Started Feb 2027

Geographic Reach

1 country

72 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

February 5, 2026

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed

1 year until next milestone

Study Start

First participant enrolled

February 14, 2027

Expected

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2029

Last Updated

July 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

February 5, 2026

Last Update Submit

July 21, 2026

Conditions

Anatomic Stage IIIA Breast Cancer AJCC v8 Anatomic Stage II Breast Cancer AJCC v8 HER2-Negative Breast Carcinoma Anatomic Stage IIIC Breast Cancer AJCC v8 Estrogen Receptor-Positive Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

Invasive breast cancer-free survival (iBCFS)
Invasive disease defined as the first occurrence of one of the following events: local invasive recurrence following mastectomy, local invasive recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, or contralateral invasive breast cancer. The distribution of iBCFS will be estimated using the Kaplan-Meier method. The hazard ratio will be estimated using Cox proportional hazard model. The primary analysis will compare treatment groups defined by the randomized treatment assignment (intent-to-treat analysis). A secondary analysis will be performed comparing groups defined by treatment received (per protocol analysis).
From randomization to invasive disease or death, up to 10 years

Secondary Outcomes (8)

Invasive disease free survival
From randomization to the first occurrence of invasive disease or death, up to 10 years
Distant disease free survival
Up to 10 years
Distant recurrence free survival
Up to 10 years
Recurrence-free interval
Up to 10 years
Overall survival
From randomization to death, up to 10 years
+3 more secondary outcomes

Other Outcomes (3)

Primary outcome treatment effect by sex
Up to 10 years
Primary outcome treatment effect by race
Up to 10 years
Primary outcome treatment effect by ethnicity
Up to 10 years

Study Arms (2)

Arm A (chemotherapy, hormone therapy, ribociclib)

ACTIVE COMPARATOR

Patients receive their physician's choice of standard of care chemotherapy. Patients then receive their physician's choice of standard of care hormone therapy with letrozole, anastrozole, or exemestane PO QD on days 1-28 of each cycle, as well as ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for at least 60 months for hormone therapy and up to 3 years for ribociclib, in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scan, bone scan, or FDG PET-CT scan and may optionally undergo blood sample collection throughout the study.

Drug: AnastrozoleProcedure: Biospecimen CollectionProcedure: Bone ScanDrug: ChemotherapyProcedure: Computed TomographyDrug: ExemestaneDrug: LetrozoleProcedure: Oncotype DX Breast Cancer AssayProcedure: Positron Emission TomographyDrug: Ribociclib Succinate

Arm B (hormone therapy, ribociclib)

EXPERIMENTAL

Patients receive their physician's choice of standard of care hormone therapy with letrozole, anastrozole, or exemestane PO QD on days 1-28 of each cycle and ribociclib PO QD on days 1-21 of each cycle. Cycles repeat every 28 days for at least 60 months for hormone therapy and up to 3 years for ribociclib, in the absence of disease progression or unacceptable toxicity. Patients undergo CT scan, bone scan, or FDG PET-CT scan and may optionally undergo blood sample collection throughout the study.

Drug: AnastrozoleProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyDrug: ExemestaneDrug: LetrozoleProcedure: Oncotype DX Breast Cancer AssayProcedure: Positron Emission TomographyDrug: Ribociclib Succinate

Interventions

ChemotherapyDRUG

Receive standard of care chemotherapy

Also known as: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General

Arm A (chemotherapy, hormone therapy, ribociclib)

ExemestaneDRUG

Given PO

Also known as: Aromasin, FCE-24304