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
8/10/2026
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
Sutter Auburn Faith Hospital
Auburn, California 95602
United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
United States
Tower Cancer Research Foundation
Beverly Hills, California 90211
United States
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Irvine, California 92612
United States
Memorial Medical Center
Modesto, California 95355
United States
UC Irvine Health/Chao Family Comprehensive Cancer Center
Orange, California 92868
United States
Palo Alto Medical Foundation Health Care
Palo Alto, California 94301
United States
Huntington Memorial Hospital
Pasadena, California 91105
United States
Sutter Roseville Medical Center
Roseville, California 95661
United States
Sutter Medical Center Sacramento
Sacramento, California 95816
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
Ridley-Tree Cancer Center
Santa Barbara, California 93105
United States
Cedars-Sinai Cancer - Tarzana
Tarzana, California 91356
United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California 94589
United States
UCI Health - Yorba Linda
Yorba Linda, California 92886
United States
Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut 06904
United States
Beebe South Coastal Health Campus
Millville, Delaware 19967
United States
Helen F Graham Cancer Center
Newark, Delaware 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
United States
Beebe Health Campus
Rehoboth Beach, Delaware 19971
United States
The Watson Clinic
Lakeland, Florida 33805
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
Northwestern University
Chicago, Illinois 60611
United States
Northwestern Medicine Cancer Center Old Irving Park
Chicago, Illinois 60641
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Illinois CancerCare-Eureka
Eureka, Illinois 61530
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
United States
Northwestern Medicine Huntley Hospital
Huntley, Illinois 60142
United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United States
Illinois CancerCare-Macomb
Macomb, Illinois 61455
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Northwestern Medicine McHenry Hospital
McHenry, Illinois 60050
United States
SSM Health Good Samaritan
Mount Vernon, Illinois 62864
United States
Carle BroMenn Medical Center
Normal, Illinois 61761
United States
Carle Cancer Institute Normal
Normal, Illinois 61761
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
Northwestern Medicine Oak Brook
Oak Brook, Illinois 60523
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
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
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
Illinois CancerCare - Washington
Washington, Illinois 61571
United States
IU Health West Hospital
Avon, Indiana 46123
United States
IU Health North Hospital
Carmel, Indiana 46032
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
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
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
The University of Kansas Cancer Center - Olathe
Olathe, Kansas 66061
United States
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas 66210
United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
United States
University of Kansas Health System Saint Francis Campus
Topeka, Kansas 66606
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
Ochsner Medical Center Jefferson
New Orleans, Louisiana 70121
United States
UM Upper Chesapeake Hematology and Oncology - Aberdeen
Aberdeen, Maryland 21001
United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland 21201
United States
Greater Baltimore Medical Center
Baltimore, Maryland 21204
United States
UM Upper Chesapeake Medical Center
Bel Air, Maryland 21014
United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland 21601
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Henry Ford Cancer Institute-Downriver
Brownstown, Michigan 48183
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
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United States
Henry Ford Medical Center-Fairlane
Dearborn, Michigan 48126
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Cancer Hematology Centers - Flint
Flint, Michigan 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Allegiance Health
Jackson, Michigan 49201
United States
University of Michigan Health - Sparrow Lansing
Lansing, Michigan 48912
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
Henry Ford Medical Center-Columbus
Novi, Michigan 48377
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
Henry Ford Wyandotte Hospital
Wyandotte, Michigan 48192
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota 56401
United States
Mercy Hospital
Coon Rapids, Minnesota 55433
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
United States
Essentia Health Saint Mary's - Detroit Lakes Clinic
Detroit Lakes, Minnesota 56501
United States
Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Miller-Dwan Hospital
Duluth, Minnesota 55805
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota 56303
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United States
Regions Hospital
Saint Paul, Minnesota 55101
United States
United Hospital
Saint Paul, Minnesota 55102
United States
Essentia Health Sandstone
Sandstone, Minnesota 55072
United States
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
United States
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
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
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri 63011
United States
Saint Francis Medical Center
Cape Girardeau, Missouri 63703
United States
Parkland Health Center - Farmington
Farmington, Missouri 63640
United States
University of Kansas Cancer Center - Briarcliff
Kansas City, Missouri 64116
United States
University of Kansas Cancer Center - North
Kansas City, Missouri 64154
United States
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri 64064
United States
Liberty Hospital
Liberty, Missouri 64068
United States
Sainte Genevieve County Memorial Hospital
Sainte Genevieve, Missouri 63670
United States
Missouri Baptist Medical Center
St Louis, Missouri 63131
United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri 63080
United States
Billings Clinic Cancer Center
Billings, Montana 59101
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
Jefferson Cherry Hill Hospital
Cherry Hill, New Jersey 08002
United States
Sidney Kimmel Cancer Center Washington Township
Sewell, New Jersey 08080
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
NYU Langone Hospital - Brooklyn
Brooklyn, New York 11220
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
NYU Langone Hospital - Long Island
Mineola, New York 11501
United States
Mount Sinai Chelsea
New York, New York 10011
United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York 10016
United States
Mount Sinai West
New York, New York 10019
United States
Mount Sinai Hospital
New York, New York 10029
United States
Good Samaritan University Hospital
West Islip, New York 11795
United States
Duke Cancer Center Cary
Cary, North Carolina 27518
United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina 28328
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina 27534
United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina 28546
United States
Duke Women's Cancer Care Raleigh
Raleigh, North Carolina 27607
United States
Essentia Health Cancer Center-South University Clinic
Fargo, North Dakota 58103
United States
Aultman Health Foundation
Canton, Ohio 44710
United States
Miami Valley Hospital South
Centerville, Ohio 45459
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Miami Valley Hospital
Dayton, Ohio 45409
United States
Premier Blood and Cancer Center
Dayton, Ohio 45409
United States
Miami Valley Hospital North
Dayton, Ohio 45415
United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio 45005-1066
United States
Miami Valley Cancer Care and Infusion
Greenville, Ohio 45331
United States
Upper Valley Medical Center
Troy, Ohio 45373
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United States
Jefferson Torresdale Hospital
Philadelphia, Pennsylvania 19114
United States
Asplundh Cancer Pavilion
Willow Grove, Pennsylvania 19090
United States
Lexington Health
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
Augusta Health Center for Cancer and Blood Disorders
Fishersville, Virginia 22939
United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia 24501
United States
Bon Secours Memorial Regional Medical Center
Mechanicsville, Virginia 23116
United States
Bon Secours Saint Francis Medical Center
Midlothian, Virginia 23114
United States
Bon Secours Richmond Community Hospital
Richmond, Virginia 23223
United States
Bon Secours Saint Mary's Hospital
Richmond, Virginia 23226
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Duluth Clinic Ashland
Ashland, Wisconsin 54806
United States
Northwest Wisconsin Cancer Center
Ashland, Wisconsin 54806
United States
Essentia Health-Hayward Clinic
Hayward, Wisconsin 54843
United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United States
Essentia Health-Spooner Clinic
Spooner, Wisconsin 54801
United States
Essentia Health Saint Mary's Hospital - Superior
Superior, Wisconsin 54880
United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin 53188
United States
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United States
Doctors Cancer Center
Manati, 00674
Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Puerto Rico
PROncology
San Juan, 00927
Puerto Rico
San Juan City Hospital
San Juan, 00936
Puerto Rico