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Testar se a Terapia Hormonal com Ribociclib é tão Eficaz como a Quimioterapia seguida de Terapia Hormonal com Ribociclib para o Tratamento do Cancro da Mama em Alto Estádio Anatómico com Baixo Risco de Recorrência, O Ensaio RxFINE-Low

5 de novembro de 2026 atualizado por: National Cancer Institute (NCI)

Um Ensaio de Fase III da Terapia Rx Guiada por Avaliação de Risco Genómico Para Cancro da Mama ER-pos/HER2-neg de Estádio Anatómico Elevado Com RS</=25 (RxFINE-Low)

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

1978

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Estados Unidos
    • Arkansas
      • Jonesboro, Arkansas, Estados Unidos, 72401
        • Recrutamento
        • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
        • Contato:
        • Investigador principal:
          • Elizabeth John
    • California
      • Auburn, California, Estados Unidos, 95602
      • Berkeley, California, Estados Unidos, 94704
        • Recrutamento
        • Alta Bates Summit Medical Center-Herrick Campus
        • Investigador principal:
          • Kristie A. Bobolis
        • Contato:
      • Beverly Hills, California, Estados Unidos, 90211
      • Fremont, California, Estados Unidos, 94538
        • Recrutamento
        • Palo Alto Medical Foundation-Fremont
        • Investigador principal:
          • Kristie A. Bobolis
        • Contato:
      • Irvine, California, Estados Unidos, 92612
        • Recrutamento
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-827-8839
          • E-mail: ucstudy@uci.edu
        • Investigador principal:
          • Ritesh Parajuli
      • Modesto, California, Estados Unidos, 95355
      • Orange, California, Estados Unidos, 92868
        • Recrutamento
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-827-8839
          • E-mail: ucstudy@uci.edu
        • Investigador principal:
          • Ritesh Parajuli
      • Palo Alto, California, Estados Unidos, 94301
        • Recrutamento
        • Palo Alto Medical Foundation Health Care
        • Investigador principal:
          • Kristie A. Bobolis
        • Contato:
      • Palo Alto, California, Estados Unidos, 94304
        • Recrutamento
        • Stanford Cancer Institute Palo Alto
        • Investigador principal:
          • Fauzia Riaz
        • Contato:
      • Pasadena, California, Estados Unidos, 91105
        • Recrutamento
        • Huntington Memorial Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 626-535-2420
        • Investigador principal:
          • Yuan Yuan
      • Roseville, California, Estados Unidos, 95661
      • Sacramento, California, Estados Unidos, 95817
        • Recrutamento
        • University of California Davis Comprehensive Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 916-734-3089
        • Investigador principal:
          • Helen K. Chew
      • Sacramento, California, Estados Unidos, 95816
      • San Francisco, California, Estados Unidos, 94115
        • Recrutamento
        • California Pacific Medical Center-Pacific Campus
        • Investigador principal:
          • Kristie A. Bobolis
        • Contato:
      • San Jose, California, Estados Unidos, 95124
        • Recrutamento
        • Stanford Cancer Center South Bay
        • Investigador principal:
          • Fauzia Riaz
        • Contato:
      • San Mateo, California, Estados Unidos, 94401
      • Santa Barbara, California, Estados Unidos, 93105
      • Tarzana, California, Estados Unidos, 91356
        • Recrutamento
        • Cedars-Sinai Cancer - Tarzana
        • Contato:
          • Site Public Contact
          • Número de telefone: 818-981-3818
        • Investigador principal:
          • Yuan Yuan
      • Vallejo, California, Estados Unidos, 94589
        • Recrutamento
        • Sutter Solano Medical Center/Cancer Center
        • Investigador principal:
          • Kristie A. Bobolis
        • Contato:
      • Yorba Linda, California, Estados Unidos, 92886
        • Recrutamento
        • UCI Health - Yorba Linda
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-827-8839
          • E-mail: ucstudy@uci.edu
        • Investigador principal:
          • Ritesh Parajuli
    • Colorado
      • Westminster, Colorado, Estados Unidos, 80023
    • Connecticut
      • Stamford, Connecticut, Estados Unidos, 06904
        • Recrutamento
        • Stamford Hospital/Bennett Cancer Center
        • Investigador principal:
          • K.M. S. Lo
        • Contato:
          • Site Public Contact
          • Número de telefone: 203-323-8944
    • Delaware
      • Millville, Delaware, Estados Unidos, 19967
        • Recrutamento
        • Beebe South Coastal Health Campus
        • Contato:
        • Investigador principal:
          • Gregory A. Masters
      • Newark, Delaware, Estados Unidos, 19713
        • Recrutamento
        • Helen F Graham Cancer Center
        • Investigador principal:
          • Gregory A. Masters
        • Contato:
      • Newark, Delaware, Estados Unidos, 19713
        • Recrutamento
        • Medical Oncology Hematology Consultants PA
        • Investigador principal:
          • Gregory A. Masters
        • Contato:
      • Rehoboth Beach, Delaware, Estados Unidos, 19971
        • Recrutamento
        • Beebe Health Campus
        • Contato:
        • Investigador principal:
          • Gregory A. Masters
    • Florida
      • Lakeland, Florida, Estados Unidos, 33805
        • Recrutamento
        • The Watson Clinic
        • Investigador principal:
          • Shalini Mulaparthi
        • Contato:
          • Site Public Contact
          • Número de telefone: 863-680-7780
    • Idaho
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Recrutamento
        • Kootenai Health - Coeur d'Alene
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Post Falls, Idaho, Estados Unidos, 83854
        • Recrutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Sandpoint, Idaho, Estados Unidos, 83864
        • Recrutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
    • Illinois
      • Bloomington, Illinois, Estados Unidos, 61704
        • Recrutamento
        • Illinois CancerCare-Bloomington
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Canton, Illinois, Estados Unidos, 61520
        • Recrutamento
        • Illinois CancerCare-Canton
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Carterville, Illinois, Estados Unidos, 62918
        • Recrutamento
        • SIH Cancer Institute
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
      • Carthage, Illinois, Estados Unidos, 62321
        • Recrutamento
        • Illinois CancerCare-Carthage
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Chicago, Illinois, Estados Unidos, 60611
        • Recrutamento
        • Northwestern University
        • Contato:
        • Investigador principal:
          • Lisa E. Flaum
      • Chicago, Illinois, Estados Unidos, 60641
        • Recrutamento
        • Northwestern Medicine Cancer Center Old Irving Park
        • Contato:
        • Investigador principal:
          • Lisa E. Flaum
      • Danville, Illinois, Estados Unidos, 61832
        • Recrutamento
        • Carle at The Riverfront
        • Investigador principal:
          • Maria T. Grosse-Perdekamp
        • Contato:
      • DeKalb, Illinois, Estados Unidos, 60115
        • Recrutamento
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contato:
        • Investigador principal:
          • Lisa E. Flaum
      • Decatur, Illinois, Estados Unidos, 62526
        • Recrutamento
        • Cancer Care Specialists of Illinois - Decatur
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
      • Decatur, Illinois, Estados Unidos, 62526
        • Recrutamento
        • Decatur Memorial Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
      • Effingham, Illinois, Estados Unidos, 62401
        • Recrutamento
        • Carle Physician Group-Effingham
        • Contato:
        • Investigador principal:
          • Maria T. Grosse-Perdekamp
      • Eureka, Illinois, Estados Unidos, 61530
        • Recrutamento
        • Illinois CancerCare-Eureka
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Galesburg, Illinois, Estados Unidos, 61401
        • Recrutamento
        • Illinois CancerCare-Galesburg
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Geneva, Illinois, Estados Unidos, 60134
        • Recrutamento
        • Northwestern Medicine Cancer Center Delnor
        • Contato:
        • Investigador principal:
          • Lisa E. Flaum
      • Glenview, Illinois, Estados Unidos, 60026
        • Recrutamento
        • Northwestern Medicine Glenview Outpatient Center
        • Investigador principal:
          • Lisa E. Flaum
        • Contato:
          • Site Public Contact
          • Número de telefone: 312-695-1102
      • Grayslake, Illinois, Estados Unidos, 60030
        • Recrutamento
        • Northwestern Medicine Grayslake Outpatient Center
        • Investigador principal:
          • Lisa E. Flaum
        • Contato:
          • Site Public Contact
          • Número de telefone: 312-695-1102
      • Huntley, Illinois, Estados Unidos, 60142
        • Recrutamento
        • Northwestern Medicine Huntley Hospital
        • Investigador principal:
          • Lisa E. Flaum
        • Contato:
          • Site Public Contact
          • Número de telefone: 815-334-5566
      • Kewanee, Illinois, Estados Unidos, 61443
        • Recrutamento
        • Illinois CancerCare-Kewanee Clinic
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Lake Forest, Illinois, Estados Unidos, 60045
        • Recrutamento
        • Northwestern Medicine Lake Forest Hospital
        • Contato:
        • Investigador principal:
          • Lisa E. Flaum
      • Macomb, Illinois, Estados Unidos, 61455
        • Recrutamento
        • Illinois CancerCare-Macomb
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Mattoon, Illinois, Estados Unidos, 61938
        • Recrutamento
        • Carle Physician Group-Mattoon/Charleston
        • Contato:
        • Investigador principal:
          • Maria T. Grosse-Perdekamp
      • McHenry, Illinois, Estados Unidos, 60050
        • Recrutamento
        • Northwestern Medicine McHenry Hospital
        • Investigador principal:
          • Lisa E. Flaum
        • Contato:
          • Site Public Contact
          • Número de telefone: 815-344-8000
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • Recrutamento
        • SSM Health Good Samaritan
        • Investigador principal:
          • Jay W. Carlson
        • Contato:
      • Normal, Illinois, Estados Unidos, 61761
        • Recrutamento
        • Carle BroMenn Medical Center
        • Investigador principal:
          • Maria T. Grosse-Perdekamp
        • Contato:
      • Normal, Illinois, Estados Unidos, 61761
        • Recrutamento
        • Carle Cancer Institute Normal
        • Investigador principal:
          • Maria T. Grosse-Perdekamp
        • Contato:
      • O'Fallon, Illinois, Estados Unidos, 62269
        • Recrutamento
        • Cancer Care Center of O'Fallon
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
      • O'Fallon, Illinois, Estados Unidos, 62269
        • Recrutamento
        • HSHS Saint Elizabeth's Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
      • Oak Brook, Illinois, Estados Unidos, 60523
      • Orland Park, Illinois, Estados Unidos, 60462
      • Ottawa, Illinois, Estados Unidos, 61350
        • Recrutamento
        • Illinois CancerCare-Ottawa Clinic
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Pekin, Illinois, Estados Unidos, 61554
        • Recrutamento
        • Illinois CancerCare-Pekin
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Peoria, Illinois, Estados Unidos, 61615
        • Recrutamento
        • Illinois CancerCare-Peoria
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Peru, Illinois, Estados Unidos, 61354
        • Recrutamento
        • Illinois CancerCare-Peru
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Princeton, Illinois, Estados Unidos, 61356
        • Recrutamento
        • Illinois CancerCare-Princeton
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
      • Springfield, Illinois, Estados Unidos, 62702
        • Recrutamento
        • Southern Illinois University School of Medicine
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
          • Site Public Contact
          • Número de telefone: 217-545-7929
      • Springfield, Illinois, Estados Unidos, 62702
        • Recrutamento
        • Springfield Clinic
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
          • Site Public Contact
          • Número de telefone: 800-444-7541
      • Springfield, Illinois, Estados Unidos, 62781
        • Recrutamento
        • Springfield Memorial Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
      • Urbana, Illinois, Estados Unidos, 61801
        • Recrutamento
        • Carle Cancer Center
        • Contato:
        • Investigador principal:
          • Maria T. Grosse-Perdekamp
      • Warrenville, Illinois, Estados Unidos, 60555
        • Recrutamento
        • Northwestern Medicine Cancer Center Warrenville
        • Contato:
        • Investigador principal:
          • Lisa E. Flaum
      • Washington, Illinois, Estados Unidos, 61571
        • Recrutamento
        • Illinois CancerCare - Washington
        • Contato:
        • Investigador principal:
          • Bryan A. Faller
    • Indiana
      • Avon, Indiana, Estados Unidos, 46123
        • Recrutamento
        • IU Health West Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 317-278-5632
          • E-mail: iutrials@iu.edu
        • Investigador principal:
          • Tarah J. Ballinger
      • Carmel, Indiana, Estados Unidos, 46032
        • Recrutamento
        • IU Health North Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 317-278-5632
          • E-mail: iutrials@iu.edu
        • Investigador principal:
          • Tarah J. Ballinger
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Recrutamento
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 317-278-5632
          • E-mail: iutrials@iu.edu
        • Investigador principal:
          • Tarah J. Ballinger
    • Iowa
      • Ames, Iowa, Estados Unidos, 50010
        • Recrutamento
        • Mary Greeley Medical Center
        • Investigador principal:
          • Joseph J. Merchant
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-956-4132
      • Ames, Iowa, Estados Unidos, 50010
        • Recrutamento
        • McFarland Clinic - Ames
        • Investigador principal:
          • Joseph J. Merchant
        • Contato:
      • Ankeny, Iowa, Estados Unidos, 50023
        • Recrutamento
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-241-3305
        • Investigador principal:
          • Seema Harichand-Herdt
      • Carroll, Iowa, Estados Unidos, 51401
        • Recrutamento
        • Saint Anthony Regional Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-689-7658
          • E-mail: sbenson@iora.org
        • Investigador principal:
          • Seema Harichand-Herdt
      • Cedar Rapids, Iowa, Estados Unidos, 52403
        • Recrutamento
        • Mercy Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 319-365-4673
        • Investigador principal:
          • Deborah W. Wilbur
      • Cedar Rapids, Iowa, Estados Unidos, 52403
        • Recrutamento
        • Oncology Associates at Mercy Medical Center
        • Investigador principal:
          • Deborah W. Wilbur
        • Contato:
          • Site Public Contact
          • Número de telefone: 319-363-2690
      • Clive, Iowa, Estados Unidos, 50325
        • Recrutamento
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-241-3305
        • Investigador principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Estados Unidos, 50314
        • Recrutamento
        • Broadlawns Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-282-2200
        • Investigador principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Estados Unidos, 50314
        • Recrutamento
        • Mercy Medical Center - Des Moines
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-241-3305
        • Investigador principal:
          • Richard L. Deming
      • Des Moines, Iowa, Estados Unidos, 50309
        • Recrutamento
        • Iowa Methodist Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-241-6727
        • Investigador principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Estados Unidos, 50309
        • Recrutamento
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-241-3305
        • Investigador principal:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Estados Unidos, 50314
        • Recrutamento
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-241-3305
        • Investigador principal:
          • Seema Harichand-Herdt
      • Fort Dodge, Iowa, Estados Unidos, 50501
        • Recrutamento
        • McFarland Clinic - Trinity Cancer Center
        • Investigador principal:
          • Joseph J. Merchant
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-956-4132
      • Fort Dodge, Iowa, Estados Unidos, 50501
        • Recrutamento
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
        • Investigador principal:
          • Seema Harichand-Herdt
        • Contato:
      • Marshalltown, Iowa, Estados Unidos, 50158
        • Recrutamento
        • McFarland Clinic - Marshalltown
        • Investigador principal:
          • Joseph J. Merchant
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-956-4132
      • Waukee, Iowa, Estados Unidos, 50263
        • Recrutamento
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Contato:
          • Site Public Contact
          • Número de telefone: 515-241-3305
        • Investigador principal:
          • Seema Harichand-Herdt
    • Kansas
      • Hays, Kansas, Estados Unidos, 67601
        • Recrutamento
        • HaysMed
        • Contato:
          • Site Public Contact
          • Número de telefone: 785-623-5774
        • Investigador principal:
          • Ryan Rader
      • Kansas City, Kansas, Estados Unidos, 66160
        • Recrutamento
        • University of Kansas Cancer Center
        • Contato:
        • Investigador principal:
          • Ryan Rader
      • Olathe, Kansas, Estados Unidos, 66061
        • Recrutamento
        • The University of Kansas Cancer Center - Olathe
        • Contato:
        • Investigador principal:
          • Ryan Rader
      • Overland Park, Kansas, Estados Unidos, 66211
        • Recrutamento
        • University of Kansas Hospital-Indian Creek Campus
        • Contato:
        • Investigador principal:
          • Ryan Rader
      • Overland Park, Kansas, Estados Unidos, 66210
        • Recrutamento
        • University of Kansas Cancer Center-Overland Park
        • Contato:
        • Investigador principal:
          • Ryan Rader
      • Topeka, Kansas, Estados Unidos, 66606
        • Recrutamento
        • University of Kansas Health System Saint Francis Campus
        • Contato:
          • Site Public Contact
          • Número de telefone: 785-295-8000
        • Investigador principal:
          • Ryan Rader
      • Westwood, Kansas, Estados Unidos, 66205
        • Recrutamento
        • University of Kansas Hospital-Westwood Cancer Center
        • Contato:
        • Investigador principal:
          • Ryan Rader
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Recrutamento
        • Ochsner Medical Center Jefferson
        • Contato:
        • Investigador principal:
          • Caitlin Taylor
    • Maine
      • Brewer, Maine, Estados Unidos, 04412
        • Recrutamento
        • Lafayette Family Cancer Center-EMMC
        • Investigador principal:
          • Sarah J. Sinclair
        • Contato:
          • Site Public Contact
          • Número de telefone: 800-987-3005
    • Maryland
      • Aberdeen, Maryland, Estados Unidos, 21001
        • Recrutamento
        • UM Upper Chesapeake Hematology and Oncology - Aberdeen
        • Investigador principal:
          • Katherine H. Tkaczuk
        • Contato:
      • Baltimore, Maryland, Estados Unidos, 21204
        • Recrutamento
        • Greater Baltimore Medical Center
        • Investigador principal:
          • Priyanka Mittar
        • Contato:
          • Site Public Contact
          • Número de telefone: 443-849-3706
      • Baltimore, Maryland, Estados Unidos, 21201
        • Recrutamento
        • University of Maryland/Greenebaum Cancer Center
        • Investigador principal:
          • Katherine H. Tkaczuk
        • Contato:
          • Site Public Contact
          • Número de telefone: 800-888-8823
      • Bel Air, Maryland, Estados Unidos, 21014
        • Recrutamento
        • UM Upper Chesapeake Medical Center
        • Investigador principal:
          • Katherine H. Tkaczuk
        • Contato:
          • Site Public Contact
          • Número de telefone: 443-643-3010
      • Easton, Maryland, Estados Unidos, 21601
        • Recrutamento
        • University of Maryland Shore Medical Center at Easton
        • Investigador principal:
          • Katherine H. Tkaczuk
        • Contato:
    • Michigan
      • Brighton, Michigan, Estados Unidos, 48114
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Brownstown, Michigan, Estados Unidos, 48183
        • Recrutamento
        • Henry Ford Cancer Institute-Downriver
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Canton, Michigan, Estados Unidos, 48188
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Chelsea, Michigan, Estados Unidos, 48118
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Clinton Township, Michigan, Estados Unidos, 48038
        • Recrutamento
        • Henry Ford Macomb Hospital-Clinton Township
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Dearborn, Michigan, Estados Unidos, 48126
        • Recrutamento
        • Henry Ford Medical Center-Fairlane
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Detroit, Michigan, Estados Unidos, 48202
        • Recrutamento
        • Henry Ford Hospital
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Escanaba, Michigan, Estados Unidos, 49829
        • Recrutamento
        • OSF Saint Francis Hospital and Medical Group
        • Investigador principal:
          • Brian L. Burnette
        • Contato:
      • Flint, Michigan, Estados Unidos, 48503
        • Recrutamento
        • Genesys Hurley Cancer Institute
        • Contato:
          • Site Public Contact
          • Número de telefone: 810-762-8038
          • E-mail: wstrong@ghci.org
        • Investigador principal:
          • Elie G. Dib
      • Flint, Michigan, Estados Unidos, 48503
        • Recrutamento
        • Cancer Hematology Centers - Flint
        • Contato:
          • Site Public Contact
          • Número de telefone: 810-762-8038
          • E-mail: wstrong@ghci.org
        • Investigador principal:
          • Elie G. Dib
      • Jackson, Michigan, Estados Unidos, 49201
        • Recrutamento
        • Allegiance Health
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Lansing, Michigan, Estados Unidos, 48912
        • Recrutamento
        • University of Michigan Health - Sparrow Lansing
        • Investigador principal:
          • Elie G. Dib
        • Contato:
      • Livonia, Michigan, Estados Unidos, 48154
        • Recrutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • Manistique, Michigan, Estados Unidos, 49854
        • Recrutamento
        • Schoolcraft Memorial Hospital
        • Investigador principal:
          • Brian L. Burnette
        • Contato:
      • Novi, Michigan, Estados Unidos, 48377
        • Recrutamento
        • Henry Ford Medical Center-Columbus
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Pontiac, Michigan, Estados Unidos, 48341
        • Recrutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contato:
        • Investigador principal:
          • Elie G. Dib
      • West Bloomfield, Michigan, Estados Unidos, 48322
        • Recrutamento
        • Henry Ford West Bloomfield Hospital
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Wyandotte, Michigan, Estados Unidos, 48192
        • Recrutamento
        • Henry Ford Wyandotte Hospital
        • Contato:
        • Investigador principal:
          • Hiba Jabbour-Aida
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contato:
        • Investigador principal:
          • Elie G. Dib
    • Minnesota
      • Bemidji, Minnesota, Estados Unidos, 56601
      • Brainerd, Minnesota, Estados Unidos, 56401
        • Recrutamento
        • Essentia Health Saint Joseph's Medical Center
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Coon Rapids, Minnesota, Estados Unidos, 55433
        • Recrutamento
        • Mercy Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Deer River, Minnesota, Estados Unidos, 56636
        • Recrutamento
        • Essentia Health - Deer River Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Detroit Lakes, Minnesota, Estados Unidos, 56501
        • Recrutamento
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Duluth, Minnesota, Estados Unidos, 55805
        • Recrutamento
        • Essentia Health Cancer Center
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Duluth, Minnesota, Estados Unidos, 55805
        • Recrutamento
        • Miller-Dwan Hospital
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Edina, Minnesota, Estados Unidos, 55435
        • Recrutamento
        • Fairview Southdale Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Edina, Minnesota, Estados Unidos, 55435
        • Recrutamento
        • Minnesota Oncology - Edina
        • Contato:
        • Investigador principal:
          • David M. King
      • Hibbing, Minnesota, Estados Unidos, 55746
        • Recrutamento
        • Essentia Health Hibbing Clinic
        • Investigador principal:
          • Bret E. Friday
        • Contato:
          • Site Public Contact
          • Número de telefone: 218-786-3308
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Recrutamento
        • Abbott-Northwestern Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Saint Cloud, Minnesota, Estados Unidos, 56303
        • Recrutamento
        • Coborn Cancer Center at Saint Cloud Hospital
        • Contato:
        • Investigador principal:
          • Donald J. Jurgens
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Recrutamento
        • Park Nicollet Clinic - Saint Louis Park
        • Contato:
        • Investigador principal:
          • David M. King
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Recrutamento
        • Regions Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Saint Paul, Minnesota, Estados Unidos, 55102
        • Recrutamento
        • United Hospital
        • Contato:
        • Investigador principal:
          • David M. King
      • Sandstone, Minnesota, Estados Unidos, 55072
        • Recrutamento
        • Essentia Health Sandstone
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Shakopee, Minnesota, Estados Unidos, 55379
        • Recrutamento
        • Saint Francis Regional Medical Center
        • Contato:
        • Investigador principal:
          • David M. King
      • Thief River Falls, Minnesota, Estados Unidos, 56701
        • Recrutamento
        • Sanford Thief River Falls Medical Center
        • Investigador principal:
          • Daniel Almquist
        • Contato:
          • Site Public Contact
          • Número de telefone: 605-312-3320
      • Virginia, Minnesota, Estados Unidos, 55792
        • Recrutamento
        • Essentia Health Virginia Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Woodbury, Minnesota, Estados Unidos, 55125
        • Recrutamento
        • Fairview Cancer Center - Woodbury
        • Investigador principal:
          • David M. King
        • Contato:
      • Worthington, Minnesota, Estados Unidos, 56187
        • Recrutamento
        • Sanford Cancer Center Worthington
        • Investigador principal:
          • Daniel Almquist
        • Contato:
          • Site Public Contact
          • Número de telefone: 605-312-3320
    • Mississippi
      • Columbus, Mississippi, Estados Unidos, 39705
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Contato:
        • Investigador principal:
          • Elizabeth John
      • Grenada, Mississippi, Estados Unidos, 38901
        • Recrutamento
        • Baptist Cancer Center-Grenada
        • Contato:
        • Investigador principal:
          • Elizabeth John
      • New Albany, Mississippi, Estados Unidos, 38652
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Contato:
        • Investigador principal:
          • Elizabeth John
      • Oxford, Mississippi, Estados Unidos, 38655
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Oxford
        • Contato:
        • Investigador principal:
          • Elizabeth John
      • Southhaven, Mississippi, Estados Unidos, 38671
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Contato:
        • Investigador principal:
          • Elizabeth John
    • Missouri
      • Ballwin, Missouri, Estados Unidos, 63011
        • Recrutamento
        • Mercy Oncology and Hematology - Clayton-Clarkson
        • Investigador principal:
          • Jay W. Carlson
        • Contato:
          • Site Public Contact
          • Número de telefone: 888-446-3729
      • Cape Girardeau, Missouri, Estados Unidos, 63703
        • Recrutamento
        • Saint Francis Medical Center
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
          • Site Public Contact
          • Número de telefone: 573-334-2230
          • E-mail: sfmc@sfmc.net
      • Columbia, Missouri, Estados Unidos, 65212
        • Recrutamento
        • MU Health - University Hospital/Ellis Fischel Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 573-882-7440
        • Investigador principal:
          • Hamsa Sahib
      • Farmington, Missouri, Estados Unidos, 63640
        • Recrutamento
        • Parkland Health Center - Farmington
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
          • Site Public Contact
          • Número de telefone: 314-996-5569
      • Kansas City, Missouri, Estados Unidos, 64154
        • Recrutamento
        • University of Kansas Cancer Center - North
        • Contato:
        • Investigador principal:
          • Ryan Rader
      • Kansas City, Missouri, Estados Unidos, 64108
        • Recrutamento
        • University Health Truman Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 816-404-4375
        • Investigador principal:
          • Ryan Rader
      • Kansas City, Missouri, Estados Unidos, 64116
        • Recrutamento
        • University of Kansas Cancer Center - Briarcliff
        • Investigador principal:
          • Ryan Rader
        • Contato:
          • Site Public Contact
          • Número de telefone: 913-588-3671
      • Lee's Summit, Missouri, Estados Unidos, 64064
        • Recrutamento
        • University of Kansas Cancer Center - Lee's Summit
        • Contato:
        • Investigador principal:
          • Ryan Rader
      • Liberty, Missouri, Estados Unidos, 64068
        • Recrutamento
        • Liberty Hospital
        • Investigador principal:
          • Ryan Rader
        • Contato:
          • Site Public Contact
          • Número de telefone: 913-588-1569
      • Sainte Genevieve, Missouri, Estados Unidos, 63670
        • Recrutamento
        • Sainte Genevieve County Memorial Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
          • Site Public Contact
          • Número de telefone: 314-996-5569
      • St Louis, Missouri, Estados Unidos, 63131
        • Recrutamento
        • Missouri Baptist Medical Center
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
          • Site Public Contact
          • Número de telefone: 314-996-5569
      • Sullivan, Missouri, Estados Unidos, 63080
        • Recrutamento
        • Missouri Baptist Sullivan Hospital
        • Investigador principal:
          • Bryan A. Faller
        • Contato:
          • Site Public Contact
          • Número de telefone: 314-996-5569
    • Montana
      • Anaconda, Montana, Estados Unidos, 59711
        • Recrutamento
        • Community Hospital of Anaconda
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Billings, Montana, Estados Unidos, 59101
        • Recrutamento
        • Billings Clinic Cancer Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Bozeman, Montana, Estados Unidos, 59715
        • Recrutamento
        • Bozeman Health Deaconess Hospital
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Great Falls, Montana, Estados Unidos, 59405
        • Recrutamento
        • Benefis Sletten Cancer Institute
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Kalispell, Montana, Estados Unidos, 59901
        • Recrutamento
        • Logan Health Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Missoula, Montana, Estados Unidos, 59804
        • Recrutamento
        • Community Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
    • Nebraska
      • Bellevue, Nebraska, Estados Unidos, 68123
        • Recrutamento
        • Nebraska Medicine-Bellevue
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-6941
          • E-mail: unmcrsa@unmc.edu
        • Investigador principal:
          • Simran A. Elder
      • Omaha, Nebraska, Estados Unidos, 68198
        • Recrutamento
        • University of Nebraska Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-6941
          • E-mail: unmcrsa@unmc.edu
        • Investigador principal:
          • Simran A. Elder
      • Omaha, Nebraska, Estados Unidos, 68118
        • Recrutamento
        • Nebraska Medicine-Village Pointe
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-5600
        • Investigador principal:
          • Simran A. Elder
    • New Jersey
      • Belleville, New Jersey, Estados Unidos, 07109
        • Recrutamento
        • Clara Maass Medical Center
        • Investigador principal:
          • Coral O. Omene
        • Contato:
      • Cherry Hill, New Jersey, Estados Unidos, 08002
        • Recrutamento
        • Jefferson Cherry Hill Hospital
        • Investigador principal:
          • Allison M. Zibelli
        • Contato:
      • Elizabeth, New Jersey, Estados Unidos, 07207
        • Recrutamento
        • Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus
        • Contato:
          • Site Public Contact
          • Número de telefone: 908-994-8000
        • Investigador principal:
          • Coral O. Omene
      • Jersey City, New Jersey, Estados Unidos, 07302
        • Recrutamento
        • Jersey City Medical Center
        • Investigador principal:
          • Coral O. Omene
        • Contato:
      • Long Branch, New Jersey, Estados Unidos, 07740
        • Recrutamento
        • Monmouth Medical Center
        • Investigador principal:
          • Coral O. Omene
        • Contato:
      • New Brunswick, New Jersey, Estados Unidos, 08903
        • Recrutamento
        • Rutgers Cancer Institute of New Jersey
        • Investigador principal:
          • Coral O. Omene
        • Contato:
          • Site Public Contact
          • Número de telefone: 732-235-7356
      • Newark, New Jersey, Estados Unidos, 07112
        • Recrutamento
        • Newark Beth Israel Medical Center
        • Investigador principal:
          • Coral O. Omene
        • Contato:
      • Sewell, New Jersey, Estados Unidos, 08080
        • Recrutamento
        • Sidney Kimmel Cancer Center Washington Township
        • Investigador principal:
          • Allison M. Zibelli
        • Contato:
      • Toms River, New Jersey, Estados Unidos, 08755
        • Recrutamento
        • Community Medical Center
        • Investigador principal:
          • Coral O. Omene
        • Contato:
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87106
        • Recrutamento
        • University of New Mexico Cancer Center
        • Investigador principal:
          • Jacklyn M. Nemunaitis
        • Contato:
    • New York
      • Brooklyn, New York, Estados Unidos, 11220
        • Recrutamento
        • NYU Langone Hospital - Brooklyn
        • Contato:
        • Investigador principal:
          • Nancy Chan
      • Buffalo, New York, Estados Unidos, 14263
        • Recrutamento
        • Roswell Park Cancer Institute
        • Contato:
        • Investigador principal:
          • Ellis G. Levine
      • East Hills, New York, Estados Unidos, 11548
        • Recrutamento
        • The Cancer Institute at Saint Francis Hospital
        • Contato:
        • Investigador principal:
          • Rajasree Roy
      • Mineola, New York, Estados Unidos, 11501
        • Recrutamento
        • NYU Langone Hospital - Long Island
        • Contato:
        • Investigador principal:
          • Nancy Chan
      • New York, New York, Estados Unidos, 10011
        • Recrutamento
        • Mount Sinai Chelsea
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-824-7309
          • E-mail: CCTO@mssm.edu
        • Investigador principal:
          • Anupama Goel
      • New York, New York, Estados Unidos, 10016
        • Recrutamento
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone
        • Contato:
        • Investigador principal:
          • Nancy Chan
      • New York, New York, Estados Unidos, 10029
        • Recrutamento
        • Mount Sinai Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-824-7309
          • E-mail: CCTO@mssm.edu
        • Investigador principal:
          • Anupama Goel
      • New York, New York, Estados Unidos, 10019
        • Recrutamento
        • Mount Sinai West
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-824-7309
          • E-mail: CCTO@mssm.edu
        • Investigador principal:
          • Anupama Goel
      • West Islip, New York, Estados Unidos, 11795
        • Recrutamento
        • Good Samaritan University Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 516-326-7514
        • Investigador principal:
          • Meytal Fabrikant
    • North Carolina
      • Cary, North Carolina, Estados Unidos, 27518
        • Suspenso
        • Duke Cancer Center Cary
      • Clinton, North Carolina, Estados Unidos, 28328
        • Recrutamento
        • Southeastern Medical Oncology Center-Clinton
        • Contato:
        • Investigador principal:
          • Samer S. Kasbari
      • Durham, North Carolina, Estados Unidos, 27710
        • Recrutamento
        • Duke University Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 888-275-3853
        • Investigador principal:
          • Alexandra Thomas
      • Goldsboro, North Carolina, Estados Unidos, 27534
        • Recrutamento
        • Southeastern Medical Oncology Center-Goldsboro
        • Contato:
        • Investigador principal:
          • Samer S. Kasbari
      • Jacksonville, North Carolina, Estados Unidos, 28546
        • Recrutamento
        • Southeastern Medical Oncology Center-Jacksonville
        • Investigador principal:
          • Samer S. Kasbari
        • Contato:
      • Raleigh, North Carolina, Estados Unidos, 27607
        • Recrutamento
        • Duke Women's Cancer Care Raleigh
        • Contato:
          • Site Public Contact
          • Número de telefone: 919-785-4878
        • Investigador principal:
          • Alexandra Thomas
    • North Dakota
      • Bismarck, North Dakota, Estados Unidos, 58501
      • Fargo, North Dakota, Estados Unidos, 58122
      • Fargo, North Dakota, Estados Unidos, 58103
        • Recrutamento
        • Essentia Health Cancer Center-South University Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Fargo, North Dakota, Estados Unidos, 58122
    • Ohio
      • Canton, Ohio, Estados Unidos, 44710
        • Recrutamento
        • Aultman Health Foundation
        • Contato:
        • Investigador principal:
          • Sunitha Vemulapalli
      • Centerville, Ohio, Estados Unidos, 45459
        • Recrutamento
        • Miami Valley Hospital South
        • Investigador principal:
          • Jhansi L. Koduri
        • Contato:
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • Ohio State University Comprehensive Cancer Center
        • Contato:
        • Investigador principal:
          • Nerea Lopetegui-Lia
      • Dayton, Ohio, Estados Unidos, 45409
        • Recrutamento
        • Miami Valley Hospital
        • Investigador principal:
          • Jhansi L. Koduri
        • Contato:
      • Dayton, Ohio, Estados Unidos, 45415
        • Recrutamento
        • Miami Valley Hospital North
        • Investigador principal:
          • Jhansi L. Koduri
        • Contato:
      • Dayton, Ohio, Estados Unidos, 45409
        • Recrutamento
        • Premier Blood and Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 937-276-8320
        • Investigador principal:
          • Jhansi L. Koduri
      • Franklin, Ohio, Estados Unidos, 45005-1066
        • Recrutamento
        • Atrium Medical Center-Middletown Regional Hospital
        • Investigador principal:
          • Jhansi L. Koduri
        • Contato:
      • Greenville, Ohio, Estados Unidos, 45331
        • Recrutamento
        • Miami Valley Cancer Care and Infusion
        • Investigador principal:
          • Jhansi L. Koduri
        • Contato:
          • Site Public Contact
          • Número de telefone: 937-569-7515
      • Troy, Ohio, Estados Unidos, 45373
        • Recrutamento
        • Upper Valley Medical Center
        • Investigador principal:
          • Jhansi L. Koduri
        • Contato:
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Recrutamento
        • University of Oklahoma Health Sciences Center
        • Contato:
        • Investigador principal:
          • Unaiza Zaman
    • Pennsylvania
      • Danville, Pennsylvania, Estados Unidos, 17822
        • Recrutamento
        • Geisinger Medical Center
        • Investigador principal:
          • Jennifer R. Collins
        • Contato:
      • Dickson City, Pennsylvania, Estados Unidos, 18519
        • Recrutamento
        • Geisinger Cancer Center Dickson City
        • Investigador principal:
          • Jennifer R. Collins
        • Contato:
      • Hershey, Pennsylvania, Estados Unidos, 17033-0850
        • Recrutamento
        • Penn State Milton S Hershey Medical Center
        • Investigador principal:
          • Cristina I. Truica
        • Contato:
          • Site Public Contact
          • Número de telefone: 717-531-3779
          • E-mail: CTO@hmc.psu.edu
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Recrutamento
        • Thomas Jefferson University Hospital
        • Investigador principal:
          • Allison M. Zibelli
        • Contato:
      • Philadelphia, Pennsylvania, Estados Unidos, 19114
        • Recrutamento
        • Jefferson Torresdale Hospital
        • Investigador principal:
          • Allison M. Zibelli
        • Contato:
      • Wilkes-Barre, Pennsylvania, Estados Unidos, 18711
        • Recrutamento
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contato:
        • Investigador principal:
          • Jennifer R. Collins
      • Willow Grove, Pennsylvania, Estados Unidos, 19090
        • Recrutamento
        • Asplundh Cancer Pavilion
        • Investigador principal:
          • Allison M. Zibelli
        • Contato:
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02905
        • Recrutamento
        • Women and Infants Hospital
        • Investigador principal:
          • William M. Sikov
        • Contato:
          • Site Public Contact
          • Número de telefone: 401-274-1122
    • South Carolina
      • West Columbia, South Carolina, Estados Unidos, 29169
        • Recrutamento
        • Lexington Health
        • Investigador principal:
          • Steven A. Madden
        • Contato:
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57104
        • Recrutamento
        • Sanford Cancer Center Oncology Clinic
        • Investigador principal:
          • Daniel Almquist
        • Contato:
      • Sioux Falls, South Dakota, Estados Unidos, 57117-5134
    • Tennessee
      • Collierville, Tennessee, Estados Unidos, 38017
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Collierville
        • Contato:
        • Investigador principal:
          • Elizabeth John
      • Memphis, Tennessee, Estados Unidos, 38120
        • Recrutamento
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contato:
        • Investigador principal:
          • Elizabeth John
    • Texas
      • Baytown, Texas, Estados Unidos, 77521
        • Recrutamento
        • Houston Methodist San Jacinto Hospital
        • Contato:
        • Investigador principal:
          • Michelle O'Shea
      • Cypress, Texas, Estados Unidos, 77429
        • Recrutamento
        • Houston Methodist Cypress Hospital
        • Contato:
        • Investigador principal:
          • Michelle O'Shea
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • Houston Methodist Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 713-790-2700
        • Investigador principal:
          • Michelle O'Shea
      • Houston, Texas, Estados Unidos, 77070
        • Recrutamento
        • Methodist Willowbrook Hospital
        • Contato:
        • Investigador principal:
          • Michelle O'Shea
      • Houston, Texas, Estados Unidos, 77094
        • Recrutamento
        • Houston Methodist West Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 832-522-2873
        • Investigador principal:
          • Michelle O'Shea
      • Nassau Bay, Texas, Estados Unidos, 77058
        • Recrutamento
        • Houston Methodist Saint John Hospital
        • Contato:
        • Investigador principal:
          • Michelle O'Shea
      • Sugar Land, Texas, Estados Unidos, 77479
        • Recrutamento
        • Houston Methodist Sugar Land Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 281-242-2873
        • Investigador principal:
          • Michelle O'Shea
      • The Woodlands, Texas, Estados Unidos, 77385
        • Recrutamento
        • Houston Methodist The Woodlands Hospital
        • Contato:
        • Investigador principal:
          • Michelle O'Shea
    • Virginia
      • Fishersville, Virginia, Estados Unidos, 22939
        • Recrutamento
        • Augusta Health Center for Cancer and Blood Disorders
        • Investigador principal:
          • Kelvin B. Raybon
        • Contato:
          • Site Public Contact
          • Número de telefone: 540-332-5960
      • Lynchburg, Virginia, Estados Unidos, 24501
        • Recrutamento
        • Centra Alan B Pearson Regional Cancer Center
        • Investigador principal:
          • Masey M. Ross
        • Contato:
      • Mechanicsville, Virginia, Estados Unidos, 23116
        • Recrutamento
        • Bon Secours Memorial Regional Medical Center
        • Contato:
        • Investigador principal:
          • William J. Irvin
      • Midlothian, Virginia, Estados Unidos, 23114
        • Recrutamento
        • Bon Secours Saint Francis Medical Center
        • Contato:
        • Investigador principal:
          • William J. Irvin
      • Richmond, Virginia, Estados Unidos, 23226
        • Recrutamento
        • Bon Secours Saint Mary's Hospital
        • Contato:
        • Investigador principal:
          • William J. Irvin
      • Richmond, Virginia, Estados Unidos, 23223
        • Recrutamento
        • Bon Secours Richmond Community Hospital
        • Contato:
        • Investigador principal:
          • William J. Irvin
      • Richmond, Virginia, Estados Unidos, 23298
        • Recrutamento
        • VCU Massey Comprehensive Cancer Center
        • Investigador principal:
          • Masey M. Ross
        • Contato:
    • Wisconsin
      • Appleton, Wisconsin, Estados Unidos, 54911
        • Recrutamento
        • ThedaCare Regional Cancer Center
        • Contato:
        • Investigador principal:
          • Shannon Schmidt
      • Ashland, Wisconsin, Estados Unidos, 54806
        • Recrutamento
        • Duluth Clinic Ashland
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Ashland, Wisconsin, Estados Unidos, 54806
        • Recrutamento
        • Northwest Wisconsin Cancer Center
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Green Bay, Wisconsin, Estados Unidos, 54301
        • Recrutamento
        • Saint Vincent Hospital Cancer Center Green Bay
        • Investigador principal:
          • Brian L. Burnette
        • Contato:
      • Green Bay, Wisconsin, Estados Unidos, 54303
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Investigador principal:
          • Brian L. Burnette
        • Contato:
      • Hayward, Wisconsin, Estados Unidos, 54843
        • Recrutamento
        • Essentia Health-Hayward Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Mukwonago, Wisconsin, Estados Unidos, 53149
        • Recrutamento
        • ProHealth D N Greenwald Center
        • Contato:
        • Investigador principal:
          • Timothy R. Wassenaar
      • Neenah, Wisconsin, Estados Unidos, 54956
        • Recrutamento
        • ThedaCare Regional Medical Center - Neenah
        • Contato:
        • Investigador principal:
          • Shannon Schmidt
      • New Richmond, Wisconsin, Estados Unidos, 54017
        • Recrutamento
        • Cancer Center of Western Wisconsin
        • Contato:
        • Investigador principal:
          • David M. King
      • Oconomowoc, Wisconsin, Estados Unidos, 53066
        • Recrutamento
        • ProHealth Oconomowoc Memorial Hospital
        • Investigador principal:
          • Timothy R. Wassenaar
        • Contato:
          • Site Public Contact
          • Número de telefone: 262-928-7878
      • Oconto Falls, Wisconsin, Estados Unidos, 54154
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Investigador principal:
          • Brian L. Burnette
        • Contato:
      • Sheboygan, Wisconsin, Estados Unidos, 53081
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Investigador principal:
          • Brian L. Burnette
        • Contato:
      • Spooner, Wisconsin, Estados Unidos, 54801
        • Recrutamento
        • Essentia Health-Spooner Clinic
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Sturgeon Bay, Wisconsin, Estados Unidos, 54235-1495
        • Recrutamento
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Investigador principal:
          • Brian L. Burnette
        • Contato:
      • Superior, Wisconsin, Estados Unidos, 54880
        • Recrutamento
        • Essentia Health Saint Mary's Hospital - Superior
        • Investigador principal:
          • Bret E. Friday
        • Contato:
          • Site Public Contact
          • Número de telefone: 701-364-6272
      • Waukesha, Wisconsin, Estados Unidos, 53188
        • Recrutamento
        • ProHealth Waukesha Memorial Hospital
        • Investigador principal:
          • Timothy R. Wassenaar
        • Contato:
          • Site Public Contact
          • Número de telefone: 262-928-7632
      • Waukesha, Wisconsin, Estados Unidos, 53188
        • Recrutamento
        • UW Cancer Center at ProHealth Care
        • Investigador principal:
          • Timothy R. Wassenaar
        • Contato:
  • Porto Rico
      • Manati, Porto Rico, 00674
        • Recrutamento
        • Doctors Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 787-621-4397
        • Investigador principal:
          • Luis J. Santos Reyes
      • San Juan, Porto Rico, 00927
        • Recrutamento
        • Centro Comprensivo de Cancer de UPR
        • Investigador principal:
          • Luis J. Santos Reyes
        • Contato:
      • San Juan, Porto Rico, 00936
        • Recrutamento
        • San Juan City Hospital
        • Investigador principal:
          • Luis J. Santos Reyes
        • Contato:
          • Site Public Contact
          • Número de telefone: 787-763-1296
      • San Juan, Porto Rico, 00927
        • Recrutamento
        • PROncology
        • Investigador principal:
          • Luis J. Santos Reyes
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • 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

    • NOTE: Menopause can be determined by any of the following:

      • Prior bilateral oophorectomy
      • Age ≥ 60 years
      • Age < 60 years with amenorrhea for ≥ 12 months and estradiol and follicle stimulating hormone (FSH) levels in the postmenopausal range

    • NOTE: FSH and estradiol levels should be repeated as clinically indicated to ensure menopausal status in patients with breast cancer with chemotherapy-induced amenorrhea

  • STEP 0: Patient must meet one of the following staging criteria postoperatively according to American Joint Committee on Cancer (AJCC) 8th edition criteria

    • pT0-T3 with 3 positive ipsilateral lymph nodes (micro-or macrometastatic disease) and no planned axillary lymph node dissection after definitive surgery in the breast and axilla with curative intent.

    • pT0-T3 with N2 or N3

    • pT3 with N0-N3

      • NOTES:

        • Patients with T4 breast cancer are not eligible.
        • Positive isolated tumor cells (ITCs) in axillary nodes without micro- or macrometastasis are considered N0 for eligibility purposes.
        • ITC does not contribute to nodal count for staging purposes

  • STEP 0: Patient must have a primary breast tumor that is estrogen receptor (ER) positive with > 10% ER expression by immunohistochemistry (IHC) as per 2020 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Estrogen Receptor Testing Guideline.

    • NOTE: ER 1-10% are reported as ER low positive. These tumors have less endocrine-sensitive disease and are not eligible)

  • STEP 0: Patient must have a primary breast tumor that is HER2-negative by current ASCO/CAP guidelines utilizing immunohistochemistry and/or fluorescence in situ hybridization (FISH)

  • STEP 0: Patient may have multicentric or multifocal breast cancer if the highest stage tumor meets eligibility criteria outlined above, and the tumor sites are felt to represent a single disease process by local pathology or other sites of disease are also ER-positive (> 10%) and HER2 negative, if such testing is completed. If local pathology feels that multicentric or multifocal disease may represent distinct disease processes repeat disease receptor testing is required other sites of disease must also be also ER-positive (> 10%) and HER2-negative

  • STEP 0: For patients who have undergone a lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. Positive posterior margin is allowed if surgeon deems no further resection possible. Patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection

  • STEP 0: For patients who have undergone mastectomy, the margins must be free of residual gross tumor. Patients with microscopic positive margins are eligible if post-mastectomy radiation treatment (RT) of the chest wall will be administered

  • STEP 0: Patient must have undergone axillary staging with sentinel lymph node biopsy (SLNB), targeted axillary dissection (TAD), or axillary lymph node dissection (ALND)

  • STEP 0: Patient must have no evidence of locoregional or distant metastatic disease by clinical history and physical exam. Treating physician can consider additional imaging evaluation per National Comprehensive Cancer Network (NCCN) guidelines and/or institutional practice

  • STEP 0: Patient must be able to have Oncotype DX testing performed.

    • If Oncotype DX testing was previously performed, the results of Recurrence Score (RS) must be available and must meet Step 1 eligibility criteria.

    • If Oncotype DX testing was not performed yet, tissue from the core, excisional biopsy or surgical specimen of the tumor lesion must be available and must be shipped to Exact Sciences for determination of the Oncotype DX Recurrence Score (RS) for eligibility and stratification.

      • NOTE: Exact Sciences will notify the submitting institution of Recurrence Score results within two (2) weeks of receipt of the tumor specimen. Institutions will receive an email notification of eligibility status once Recurrence Score results are entered into Rave by the submitting institution

  • STEP 0: Patient must have had their final cancer surgery for breast cancer (including re-excision of margins) less than 16 weeks prior to Step 0 Pre-Registration.

    • NOTE: This excludes additional surgery for reconstructive purposes

  • STEP 0: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • STEP 0: Patients with synchronous DCIS or LCIS are eligible

  • STEP 0: Patient with prior history of ER-negative DCIS diagnosed at least 5 years prior to Step 0 Pre-Registration without evidence of recurrence are eligible

  • STEP 0: Patient must not have a prior history of invasive ER-positive breast cancer. Patients with a history of ER-negative breast cancer are eligible if they were diagnosed at least 5 years prior to Step 0 Pre-Registration and have had no evidence of recurrence

  • STEP 0: Patients must not have received prior endocrine therapy such as tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention within 5 years prior to Step 0 Pre-Registration with the exception of a short course of endocrine therapy of less than 6 weeks duration prior to Step 0 Pre-Registration.

    • NOTE: The Oncotype DX for study eligibility must be performed on specimen obtained prior to initiation of any endocrine therapy

  • STEP 0: Patient must not be concurrently using systemic hormone replacement therapy (HRT). If receiving HRT at the time of breast cancer diagnosis, this must be discontinued prior to Step 0 Pre-Registration with appropriate washout

  • STEP 0: Absolute neutrophil count (ANC) ≥ 1,500/µL (obtained ≤ 28 days prior to Step 0 Pre-Registration)

  • STEP 0: Hemoglobin ≥ 9.0 g/dL (obtained ≤ 28 days prior to Step 0 Pre-Registration)

  • STEP 0: Platelets ≥ 100,000/µL (obtained ≤ 28 days prior to Step 0 Pre-Registration)

  • STEP 0: Total bilirubin ≤ institutional upper limit of normal (ULN) or < 1.5 x ULN for patients who have a bilirubin elevation in patients with well documented Gilbert's disease or similar syndrome involving slow conjugation of bilirubin (obtained ≤ 28 days prior to Step 0 Pre-Registration)

  • STEP 0: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 × institutional ULN (obtained ≤ 28 days prior to Step 0 Pre-Registration)

  • STEP 0: Estimated glomerular filtration rate (eGFR) ≥ 30 mL/minute/1.73 m^2 (obtained ≤ 28 days prior to Step 0 Pre-Registration)

  • STEP 0: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 Pre-Registration are eligible for this trial

  • STEP 0: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • STEP 0: Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • STEP 0: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better

  • STEP 0: Patient must have a standard 12-lead electrocardiogram (ECG) within 28 days prior to Step 0 Pre-Registration, documenting:

    • QT interval using Fridericia's correction (QTcF) < 450 msec.
    • Resting heart rate 50-90 beats per minute (determined from the ECG)

  • STEP 0: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • STEP 0: Patient must not have comorbidities considered a safety risk for standard adjuvant chemotherapy, endocrine therapy or CDK4/6 inhibitor as per Investigator's discretion

  • STEP 0: Patient must not have a contraindication to adjuvant chemotherapy based on treating physician's discretion

  • STEP 0: Patient must not have received prior chemotherapy for this malignancy

  • STEP 0: Patient must not have received prior CDK4/6 inhibitor

  • STEP 0: Patient must not have a known contraindication to ribociclib per current Food and Drug Administration (FDA) indication

  • STEP 0: Patient must not have a known hypersensitivity to any of the excipients of ribociclib and/or endocrine therapy (ET) (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy)

  • STEP 0: Males must not expect to father children and males and their partners must be willing to use highly effective methods of contraception while on protocol treatment. Males must not donate sperm while on protocol treatment and for at least 12 weeks following the last dose of protocol treatment.

Highly effective methods include the following:

  • Intrauterine device

  • Bilateral tubal occlusion

  • Vasectomized partner

  • Sexual abstinence If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, or in the event of sexual activity of low frequency, a combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods) is also considered an acceptable birth control method. Local regulation/guidelines are to be followed with regard to highly effective birth control method, if more restrictive

    • STEP 1: Patient must meet all Step 0 Pre-Registration eligibility criteria at the time of their Step 1 randomization
    • STEP 1: Patient must not have had any major surgery or radiotherapy within 14 days prior to Step 1 randomization
    • STEP 1: Patient must have a Recurrence Score (RS) of 0-25 from Oncotype DX testing from diagnostic biopsy or surgical specimen as reported by the Exact Sciences assay

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm A (chemotherapy, hormone therapy, ribociclib)

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.
Medicamento: Anastrozole

Given PO

Outros nomes:
  • Arimidex
  • Anastrazol
  • ICI D1033
  • ICI-D1033
  • ZD-1033
Medicamento: Exemestane

Given PO

Outros nomes:
  • Aromasin
  • FCE-24304
Medicamento: Letrozole

Given PO

Outros nomes:
  • CGS 20267
  • Femara
  • Fempro
  • CGS-20267
  • CGS20267
Procedimento: Biospecimen Collection

Undergo blood sample collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Procedimento: Computed Tomography

Undergo CT scan

Outros nomes:
  • TC
  • GATO
  • Tomografia
  • Tomografia Axial Computadorizada
  • Tomografia computadorizada
  • tomografia
  • Tomografia axial computadorizada (procedimento)
  • Tomografia computadorizada (TC)
  • Diagnóstico Cat Scan
  • Tipo de serviço de varredura de gato diagnóstico
Procedimento: Bone Scan

Undergo bone scan

Outros nomes:
  • Cintilografia Óssea
Medicamento: Chemotherapy

Receive standard of care chemotherapy

Outros nomes:
  • Quimioterapia
  • Quimioterapia (NOS)
  • Quimioterapia, Câncer, Geral
Procedimento: Oncotype DX Breast Cancer Assay

Undergo risk recurrence testing

Outros nomes:
  • Oncotype DX
Procedimento: Positron Emission Tomography

Undergo FDG PET scan

Outros nomes:
  • Imagem Médica, Tomografia por Emissão de Pósitrons
  • BICHO DE ESTIMAÇÃO
  • PET scan
  • Tomografia por emissão de pósitrons
  • PT
  • Tomografia por emissão de pósitrons (procedimento)
Medicamento: Ribociclib Succinate

Given PO

Outros nomes:
  • Kisqali
Experimental: Arm B (hormone therapy, ribociclib)

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.
Medicamento: Anastrozole

Given PO

Outros nomes:
  • Arimidex
  • Anastrazol
  • ICI D1033
  • ICI-D1033
  • ZD-1033
Medicamento: Exemestane

Given PO

Outros nomes:
  • Aromasin
  • FCE-24304
Medicamento: Letrozole

Given PO

Outros nomes:
  • CGS 20267
  • Femara
  • Fempro
  • CGS-20267
  • CGS20267
Procedimento: Biospecimen Collection

Undergo blood sample collection

Outros nomes:
  • Coleta de Amostras Biológicas
  • Bioespécime coletado
  • Coleta de amostras
Procedimento: Computed Tomography

Undergo CT scan

Outros nomes:
  • TC
  • GATO
  • Tomografia
  • Tomografia Axial Computadorizada
  • Tomografia computadorizada
  • tomografia
  • Tomografia axial computadorizada (procedimento)
  • Tomografia computadorizada (TC)
  • Diagnóstico Cat Scan
  • Tipo de serviço de varredura de gato diagnóstico
Procedimento: Bone Scan

Undergo bone scan

Outros nomes:
  • Cintilografia Óssea
Procedimento: Oncotype DX Breast Cancer Assay

Undergo risk recurrence testing

Outros nomes:
  • Oncotype DX
Procedimento: Positron Emission Tomography

Undergo FDG PET scan

Outros nomes:
  • Imagem Médica, Tomografia por Emissão de Pósitrons
  • BICHO DE ESTIMAÇÃO
  • PET scan
  • Tomografia por emissão de pósitrons
  • PT
  • Tomografia por emissão de pósitrons (procedimento)
Medicamento: Ribociclib Succinate

Given PO

Outros nomes:
  • Kisqali

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Invasive breast cancer-free survival (iBCFS)
Prazo: From randomization to invasive disease or death, up to 10 years

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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Invasive disease free survival
Prazo: From randomization to the first occurrence of invasive disease or death, up to 10 years

Occurrence of 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, contralateral invasive breast cancer, or second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin). Will be defined according to Standardized Definitions for Efficacy End Points (in Adjuvant Breast Cancer Trials) (STEEP) criteria and analyzed similarly as iBCFS.
From randomization to the first occurrence of invasive disease or death, up to 10 years
Distant disease free survival
Prazo: Up to 10 years

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Up to 10 years
Distant recurrence free survival
Prazo: Up to 10 years

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Up to 10 years
Recurrence-free interval
Prazo: Up to 10 years

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Up to 10 years
Overall survival
Prazo: From randomization to death, up to 10 years

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
From randomization to death, up to 10 years
Breast cancer specific survival
Prazo: Up to 10 years

Will be defined according to STEEP criteria and analyzed similarly as iBCFS.
Up to 10 years
Incidence of short term adverse events
Prazo: Up to 10 years

Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE). Will be summarized by treatment group and the NCI CTCAE worst grade.
Up to 10 years
Incidence of long term adverse events
Prazo: Up to 10 years

Adverse events will be graded using the NCI CTCAE. Will be summarized by treatment group and the NCI CTCAE worst grade.
Up to 10 years

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Primary outcome treatment effect by sex
Prazo: Up to 10 years

Estimates of treatment effect and the corresponding 95% confidence intervals (CIs) will be provided.
Up to 10 years
Primary outcome treatment effect by race
Prazo: Up to 10 years

Estimates of treatment effect and the corresponding 95% CIs will be provided.
Up to 10 years
Primary outcome treatment effect by ethnicity
Prazo: Up to 10 years

Estimates of treatment effect and the corresponding 95% CIs will be provided.
Up to 10 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Nancy Chan, ECOG-ACRIN Cancer Research Group

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

10 de agosto de 2026

Conclusão Primária (Estimado)

31 de julho de 2029

Conclusão do estudo (Estimado)

31 de julho de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

5 de fevereiro de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

5 de fevereiro de 2026

Primeira postagem (Real)

6 de fevereiro de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

6 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de novembro de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NCI-2026-00634
  • U10CA180820 (Concessão/Contrato do NIH dos EUA)
  • NCI-2026-00634 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
  • EA1242 (Outro identificador: CTEP)
  • EA1242 (Outro identificador: ECOG-ACRIN Cancer Research Group)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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