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
Start Date
2/14/2027
Completion Date
7/31/2029
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.
Detailed Description
PRIMARY OBJECTIVE: I. To determine whether optimal adjuvant endocrine therapy with CDK4/6 inhibitor is non-inferior to adjuvant chemotherapy followed by optimal endocrine therapy with CDK4/6 inhibitor as evaluated by invasive breast cancer-free survival (iBCFS). SECONDARY OBJECTIVES: I. To compare 5-year invasive disease-free survival (iDFS), distant disease-free survival (DDFS), distant recurrence-free survival (DRFS), recurrence-free interval (RFI), overall survival (OS), and breast cancer-specific survival (BCSS) in patients who receive adjuvant chemotherapy versus patients who do not. II. To compare the short-term and long-term toxicity profiles of each arm. EXPLORATORY OBJECTIVE: I. To create a biorepository of tumor tissue and peripheral blood biospecimens for future research. OUTLINE: STEP 0: Patients undergo Oncotype DX risk recurrence testing. Patients with an Oncotype DX recurrence score of 0-25 proceed to step 1. Patients with a recurrence score of 26-100 do not continue on the study. STEP 1: Patients are randomized to 1 of 2 arms. ARM A: 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 orally (PO) once daily (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 computed tomography (CT) scan, bone scan, or fludeoxyglucose (FDG) positron emission tomography (PET)-CT scan and may optionally undergo blood sample collection throughout the study. ARM B: 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. Patients are followed every 3 months for 12 months from randomization, every 6 months for years 1-5 from randomization, then every 12 months for years 5-10 from randomization.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Anastrozole
Biospecimen Collection
Bone Scan
Chemotherapy
Computed Tomography
Exemestane
Letrozole
Oncotype DX Breast Cancer Assay
Positron Emission Tomography
Ribociclib Succinate
Conditions
Locations
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro, Arkansas 72401
United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
United States
Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
United States
Sutter Roseville Medical Center
Roseville, California 95661
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
California Pacific Medical Center-Pacific Campus
San Francisco, California 94115
United States
Mills Health Center
San Mateo, California 94401
United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut 06904
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
United States
Illinois CancerCare-Canton
Canton, Illinois 61520
United States
SIH Cancer Institute
Carterville, Illinois 62918
United States
Illinois CancerCare-Carthage
Carthage, Illinois 62321
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
SSM Health Good Samaritan
Mount Vernon, Illinois 62864
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
HSHS Saint Elizabeth's Hospital
O'Fallon, Illinois 62269
United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350
United States
Illinois CancerCare-Pekin
Pekin, Illinois 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois 61615
United States
Illinois CancerCare-Peru
Peru, Illinois 61354
United States
Illinois CancerCare-Princeton
Princeton, Illinois 61356
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Springfield Memorial Hospital
Springfield, Illinois 62781
United States
Illinois CancerCare - Washington
Washington, Illinois 61571
United States
Mary Greeley Medical Center
Ames, Iowa 50010
United States
McFarland Clinic - Ames
Ames, Iowa 50010
United States
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa 50023
United States
Saint Anthony Regional Hospital
Carroll, Iowa 51401
United States
Mercy Hospital
Cedar Rapids, Iowa 52403
United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa 52403
United States
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa 50325
United States
Iowa Methodist Medical Center
Des Moines, Iowa 50309
United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa 50309
United States
Broadlawns Medical Center
Des Moines, Iowa 50314
United States
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United States
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa 50314
United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa 50501
United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
United States
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa 50263
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
United States
Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United States
Community Medical Center
Missoula, Montana 59804
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Lexington Medical Center
West Columbia, South Carolina 29169
United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
United States