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
Sponsor: National Cancer Institute (NCI) • ClinicalTrials.gov ID: NCT07391774
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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.
Interventions
-
Anastrozole
(Drug)
Given PO
-
Biospecimen Collection
(Procedure)
Undergo blood sample collection
-
Bone Scan
(Procedure)
Undergo bone scan
-
Chemotherapy
(Drug)
Receive standard of care chemotherapy
-
Computed Tomography
(Procedure)
Undergo CT scan
-
Exemestane
(Drug)
Given PO
-
Letrozole
(Drug)
Given PO
-
Oncotype DX Breast Cancer Assay
(Procedure)
Undergo risk recurrence testing
-
Positron Emission Tomography
(Procedure)
Undergo FDG PET scan
-
Ribociclib Succinate
(Drug)
Given PO
Eligibility criteria
Conditions
Locations
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro — Jonesboro, Arkansas, United States
- Sutter Auburn Faith Hospital — Auburn, California, United States
- Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
- Tower Cancer Research Foundation — Beverly Hills, California, United States
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care — Irvine, California, United States
- Memorial Medical Center — Modesto, California, United States
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
- Palo Alto Medical Foundation Health Care — Palo Alto, California, United States
- Huntington Memorial Hospital — Pasadena, California, United States
- Sutter Roseville Medical Center — Roseville, California, United States
- Sutter Medical Center Sacramento — Sacramento, California, United States
- University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
- California Pacific Medical Center-Pacific Campus — San Francisco, California, United States
- Mills Health Center — San Mateo, California, United States
- Ridley-Tree Cancer Center — Santa Barbara, California, United States
- Cedars-Sinai Cancer - Tarzana — Tarzana, California, United States
- Sutter Solano Medical Center/Cancer Center — Vallejo, California, United States
- UCI Health - Yorba Linda — Yorba Linda, California, United States
- Stamford Hospital/Bennett Cancer Center — Stamford, Connecticut, United States
- Beebe South Coastal Health Campus — Millville, Delaware, United States
- Helen F Graham Cancer Center — Newark, Delaware, United States
- Medical Oncology Hematology Consultants PA — Newark, Delaware, United States
- Beebe Health Campus — Rehoboth Beach, Delaware, United States
- The Watson Clinic — Lakeland, Florida, United States
- Kootenai Health - Coeur d'Alene — Coeur d'Alene, Idaho, United States
- Kootenai Clinic Cancer Services - Post Falls — Post Falls, Idaho, United States
- Kootenai Clinic Cancer Services - Sandpoint — Sandpoint, Idaho, United States
- Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
- Illinois CancerCare-Canton — Canton, Illinois, United States
- SIH Cancer Institute — Carterville, Illinois, United States
- Illinois CancerCare-Carthage — Carthage, Illinois, United States
- Northwestern University — Chicago, Illinois, United States
- Northwestern Medicine Cancer Center Old Irving Park — Chicago, Illinois, United States
- Carle at The Riverfront — Danville, Illinois, United States
- Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
- Decatur Memorial Hospital — Decatur, Illinois, United States
- Northwestern Medicine Cancer Center Kishwaukee — DeKalb, Illinois, United States
- Carle Physician Group-Effingham — Effingham, Illinois, United States
- Illinois CancerCare-Eureka — Eureka, Illinois, United States
- Illinois CancerCare-Galesburg — Galesburg, Illinois, United States
- Northwestern Medicine Cancer Center Delnor — Geneva, Illinois, United States
- Northwestern Medicine Glenview Outpatient Center — Glenview, Illinois, United States
- Northwestern Medicine Grayslake Outpatient Center — Grayslake, Illinois, United States
- Northwestern Medicine Huntley Hospital — Huntley, Illinois, United States
- Illinois CancerCare-Kewanee Clinic — Kewanee, Illinois, United States
- Northwestern Medicine Lake Forest Hospital — Lake Forest, Illinois, United States
- Illinois CancerCare-Macomb — Macomb, Illinois, United States
- Carle Physician Group-Mattoon/Charleston — Mattoon, Illinois, United States
- Northwestern Medicine McHenry Hospital — McHenry, Illinois, United States
- SSM Health Good Samaritan — Mount Vernon, Illinois, United States
- Carle BroMenn Medical Center — Normal, Illinois, United States
- Carle Cancer Institute Normal — Normal, Illinois, United States
- Cancer Care Center of O'Fallon — O'Fallon, Illinois, United States
- HSHS Saint Elizabeth's Hospital — O'Fallon, Illinois, United States
- Northwestern Medicine Oak Brook — Oak Brook, Illinois, United States
- Northwestern Medicine Orland Park — Orland Park, Illinois, United States
- Illinois CancerCare-Ottawa Clinic — Ottawa, Illinois, United States
- Illinois CancerCare-Pekin — Pekin, Illinois, United States
- Illinois CancerCare-Peoria — Peoria, Illinois, United States
- Illinois CancerCare-Peru — Peru, Illinois, United States
- Illinois CancerCare-Princeton — Princeton, Illinois, United States
- Southern Illinois University School of Medicine — Springfield, Illinois, United States
- Springfield Clinic — Springfield, Illinois, United States
- Springfield Memorial Hospital — Springfield, Illinois, United States
- Carle Cancer Center — Urbana, Illinois, United States
- Northwestern Medicine Cancer Center Warrenville — Warrenville, Illinois, United States
- Illinois CancerCare - Washington — Washington, Illinois, United States
- IU Health West Hospital — Avon, Indiana, United States
- IU Health North Hospital — Carmel, Indiana, United States
- Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- Mary Greeley Medical Center — Ames, Iowa, United States
- McFarland Clinic - Ames — Ames, Iowa, United States
- UI Health Care Mission Cancer and Blood - Ankeny Clinic — Ankeny, Iowa, United States
- Saint Anthony Regional Hospital — Carroll, Iowa, United States
- Mercy Hospital — Cedar Rapids, Iowa, United States
- Oncology Associates at Mercy Medical Center — Cedar Rapids, Iowa, United States
- UI Health Care Mission Cancer and Blood - West Des Moines Clinic — Clive, Iowa, United States
- Iowa Methodist Medical Center — Des Moines, Iowa, United States
- UI Health Care Mission Cancer and Blood - Des Moines Clinic — Des Moines, Iowa, United States
- Broadlawns Medical Center — Des Moines, Iowa, United States
- Mercy Medical Center - Des Moines — Des Moines, Iowa, United States
- UI Health Care Mission Cancer and Blood - Laurel Clinic — Des Moines, Iowa, United States
- McFarland Clinic - Trinity Cancer Center — Fort Dodge, Iowa, United States
- UI Healthcare Mission Cancer and Blood - Fort Dodge — Fort Dodge, Iowa, United States
- McFarland Clinic - Marshalltown — Marshalltown, Iowa, United States
- UI Health Care Mission Cancer and Blood - Waukee Clinic — Waukee, Iowa, United States
- University of Kansas Cancer Center — Kansas City, Kansas, United States
- The University of Kansas Cancer Center - Olathe — Olathe, Kansas, United States
- University of Kansas Cancer Center-Overland Park — Overland Park, Kansas, United States
- University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas, United States
- University of Kansas Health System Saint Francis Campus — Topeka, Kansas, United States
- University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas, United States
- Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
- UM Upper Chesapeake Hematology and Oncology - Aberdeen — Aberdeen, Maryland, United States
- University of Maryland/Greenebaum Cancer Center — Baltimore, Maryland, United States
- Greater Baltimore Medical Center — Baltimore, Maryland, United States
- UM Upper Chesapeake Medical Center — Bel Air, Maryland, United States
- University of Maryland Shore Medical Center at Easton — Easton, Maryland, United States
- Trinity Health IHA Medical Group Hematology Oncology - Brighton — Brighton, Michigan, United States
- Henry Ford Cancer Institute-Downriver — Brownstown, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Canton — Canton, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital — Chelsea, Michigan, United States
- Henry Ford Macomb Hospital-Clinton Township — Clinton Township, Michigan, United States
- Henry Ford Medical Center-Fairlane — Dearborn, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- Cancer Hematology Centers - Flint — Flint, Michigan, United States
- Genesys Hurley Cancer Institute — Flint, Michigan, United States
- Allegiance Health — Jackson, Michigan, United States
- University of Michigan Health - Sparrow Lansing — Lansing, Michigan, United States
- Trinity Health Saint Mary Mercy Livonia Hospital — Livonia, Michigan, United States
- Henry Ford Medical Center-Columbus — Novi, Michigan, United States
- Trinity Health Saint Joseph Mercy Oakland Hospital — Pontiac, Michigan, United States
- Henry Ford West Bloomfield Hospital — West Bloomfield, Michigan, United States
- Henry Ford Wyandotte Hospital — Wyandotte, Michigan, United States
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus — Ypsilanti, Michigan, United States
- Sanford Joe Lueken Cancer Center — Bemidji, Minnesota, United States
- Essentia Health Saint Joseph's Medical Center — Brainerd, Minnesota, United States
- Mercy Hospital — Coon Rapids, Minnesota, United States
- Essentia Health - Deer River Clinic — Deer River, Minnesota, United States
- Essentia Health Saint Mary's - Detroit Lakes Clinic — Detroit Lakes, Minnesota, United States
- Essentia Health Cancer Center — Duluth, Minnesota, United States
- Miller-Dwan Hospital — Duluth, Minnesota, United States
- Essentia Health Hibbing Clinic — Hibbing, Minnesota, United States
- Abbott-Northwestern Hospital — Minneapolis, Minnesota, United States
- Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
- Park Nicollet Clinic - Saint Louis Park — Saint Louis Park, Minnesota, United States
- Regions Hospital — Saint Paul, Minnesota, United States
- United Hospital — Saint Paul, Minnesota, United States
- Essentia Health Sandstone — Sandstone, Minnesota, United States
- Saint Francis Regional Medical Center — Shakopee, Minnesota, United States
- Sanford Thief River Falls Medical Center — Thief River Falls, Minnesota, United States
- Essentia Health Virginia Clinic — Virginia, Minnesota, United States
- Sanford Cancer Center Worthington — Worthington, Minnesota, United States
- Baptist Memorial Hospital and Cancer Center-Golden Triangle — Columbus, Mississippi, United States
- Baptist Cancer Center-Grenada — Grenada, Mississippi, United States
- Baptist Memorial Hospital and Cancer Center-Union County — New Albany, Mississippi, United States
- Baptist Memorial Hospital and Cancer Center-Oxford — Oxford, Mississippi, United States
- Baptist Memorial Hospital and Cancer Center-Desoto — Southhaven, Mississippi, United States
- Mercy Oncology and Hematology - Clayton-Clarkson — Ballwin, Missouri, United States
- Saint Francis Medical Center — Cape Girardeau, Missouri, United States
- Parkland Health Center - Farmington — Farmington, Missouri, United States
- University of Kansas Cancer Center - Briarcliff — Kansas City, Missouri, United States
- University of Kansas Cancer Center - North — Kansas City, Missouri, United States
- University of Kansas Cancer Center - Lee's Summit — Lee's Summit, Missouri, United States
- Liberty Hospital — Liberty, Missouri, United States
- Sainte Genevieve County Memorial Hospital — Sainte Genevieve, Missouri, United States
- Missouri Baptist Medical Center — St Louis, Missouri, United States
- Missouri Baptist Sullivan Hospital — Sullivan, Missouri, United States
- Billings Clinic Cancer Center — Billings, Montana, United States
- Bozeman Health Deaconess Hospital — Bozeman, Montana, United States
- Benefis Sletten Cancer Institute — Great Falls, Montana, United States
- Logan Health Medical Center — Kalispell, Montana, United States
- Community Medical Center — Missoula, Montana, United States
- Jefferson Cherry Hill Hospital — Cherry Hill, New Jersey, United States
- Monmouth Medical Center — Long Branch, New Jersey, United States
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
- Sidney Kimmel Cancer Center Washington Township — Sewell, New Jersey, United States
- University of New Mexico Cancer Center — Albuquerque, New Mexico, United States
- NYU Langone Hospital - Brooklyn — Brooklyn, New York, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- The Cancer Institute at Saint Francis Hospital — East Hills, New York, United States
- NYU Langone Hospital - Long Island — Mineola, New York, United States
- Mount Sinai Chelsea — New York, New York, United States
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York, United States
- Mount Sinai West — New York, New York, United States
- Mount Sinai Hospital — New York, New York, United States
- Good Samaritan University Hospital — West Islip, New York, United States
- Duke Cancer Center Cary — Cary, North Carolina, United States
- Southeastern Medical Oncology Center-Clinton — Clinton, North Carolina, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Southeastern Medical Oncology Center-Goldsboro — Goldsboro, North Carolina, United States
- Southeastern Medical Oncology Center-Jacksonville — Jacksonville, North Carolina, United States
- Duke Women's Cancer Care Raleigh — Raleigh, North Carolina, United States
- Sanford Bismarck Medical Center — Bismarck, North Dakota, United States
- Essentia Health Cancer Center-South University Clinic — Fargo, North Dakota, United States
- Sanford Broadway Medical Center — Fargo, North Dakota, United States
- Sanford Roger Maris Cancer Center — Fargo, North Dakota, United States
- Aultman Health Foundation — Canton, Ohio, United States
- Miami Valley Hospital South — Centerville, Ohio, United States
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
- Miami Valley Hospital — Dayton, Ohio, United States
- Premier Blood and Cancer Center — Dayton, Ohio, United States
- Miami Valley Hospital North — Dayton, Ohio, United States
- Atrium Medical Center-Middletown Regional Hospital — Franklin, Ohio, United States
- Miami Valley Cancer Care and Infusion — Greenville, Ohio, United States
- Upper Valley Medical Center — Troy, Ohio, United States
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
- Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
- Jefferson Torresdale Hospital — Philadelphia, Pennsylvania, United States
- Asplundh Cancer Pavilion — Willow Grove, Pennsylvania, United States
- Lexington Health — West Columbia, South Carolina, United States
- Sanford Cancer Center Oncology Clinic — Sioux Falls, South Dakota, United States
- Sanford USD Medical Center - Sioux Falls — Sioux Falls, South Dakota, United States
- Baptist Memorial Hospital and Cancer Center-Collierville — Collierville, Tennessee, United States
- Baptist Memorial Hospital and Cancer Center-Memphis — Memphis, Tennessee, United States
- Augusta Health Center for Cancer and Blood Disorders — Fishersville, Virginia, United States
- Centra Alan B Pearson Regional Cancer Center — Lynchburg, Virginia, United States
- Bon Secours Memorial Regional Medical Center — Mechanicsville, Virginia, United States
- Bon Secours Saint Francis Medical Center — Midlothian, Virginia, United States
- Bon Secours Richmond Community Hospital — Richmond, Virginia, United States
- Bon Secours Saint Mary's Hospital — Richmond, Virginia, United States
- VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States
- Duluth Clinic Ashland — Ashland, Wisconsin, United States
- Northwest Wisconsin Cancer Center — Ashland, Wisconsin, United States
- Essentia Health-Hayward Clinic — Hayward, Wisconsin, United States
- ProHealth D N Greenwald Center — Mukwonago, Wisconsin, United States
- Cancer Center of Western Wisconsin — New Richmond, Wisconsin, United States
- ProHealth Oconomowoc Memorial Hospital — Oconomowoc, Wisconsin, United States
- Essentia Health-Spooner Clinic — Spooner, Wisconsin, United States
- Essentia Health Saint Mary's Hospital - Superior — Superior, Wisconsin, United States
- ProHealth Waukesha Memorial Hospital — Waukesha, Wisconsin, United States
- UW Cancer Center at ProHealth Care — Waukesha, Wisconsin, United States
- Doctors Cancer Center — Manati, Puerto Rico
- Centro Comprensivo de Cancer de UPR — San Juan, Puerto Rico
- PROncology — San Juan, Puerto Rico
- San Juan City Hospital — San Juan, Puerto Rico
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