Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Et forsøg for at evaluere effektiviteten og sikkerheden af ​​Ribociclib med endokrin terapi som adjuverende behandling hos patienter med HR+/HER2 - tidlig brystkræft (NATALEE)

8. oktober 2026 opdateret af: Novartis Pharmaceuticals

Et fase III multicenter, randomiseret, åbent forsøg for at evaluere effektiviteten og sikkerheden af ​​Ribociclib med endokrin terapi som en adjuverende behandling hos patienter med hormonreceptorpositiv, HER2-negativ tidlig brystkræft (nyt adjuverende forsøg med Ribociclib [LEE011] : NATALEE)

A phase III, multicenter, randomized, open-label trial to evaluate the efficacy and safety of ribociclib with Endocrine Therapy (ET) as an adjuvant treatment in women and men with Hormone Receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) Early Breast Cancer (EBC).

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Aktiv, ikke rekrutterende

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

The trial will include pre and postmenopausal women and men with HR-positive, HER2-negative EBC, with an Anatomic Stage Group III, IIB or a subset of Stage IIA cases, after adequate surgical resection, radiotherapy (if indicated), adjuvant or neoadjuvant chemotherapy (if indicated), and who are deemed to be eligible for adjuvant ET for at least 60 months of duration.

Approximately 5,000 patients will be randomized (using an Interactive Response Technology system [IRT]) into two treatment arms in a 1:1 ratio to:

• Investigational arm:

~ Ribociclib 400 mg by mouth once daily on days 1 to 21 of a 28-day cycle, for 36 months since randomization (approximately 39 cycles).

And

~ ET consisting of:

  • For postmenopausal women: letrozole 2.5 mg by mouth once daily continuously or anastrozole 1 mg by mouth once daily continuously.
  • For premenopausal women and men: letrozole 2.5 mg by mouth once daily continuously or anastrozole 1 mg by mouth once daily continuously, combined with goserelin 3.6 mg subcutaneously once every 4 weeks.

Duration of ET in the trial will be 60 months from the randomization date.

• Control arm:

~ ET: Same as in the Investigational arm.

In both arms, ET will be administered according to the local clinical guidelines and current local prescribing information. Subsequent ET (or any other anti-cancer treatment) given after the protocol-required 60 months of ET (or after premature discontinuation of ET in the trial) will be administered according to the Investigator's clinical judgment and is not considered a trial treatment.

Randomization will be stratified by the following factors:

  • Menopausal status: premenopausal women and men vs. postmenopausal women
  • AJCC 8th edition Anatomic Stage Group: Anatomic Stage Group II vs. Anatomic Stage Group III
  • Prior neoadjuvant/adjuvant chemotherapy: yes vs. no
  • Geographical region: North America/Western Europe/Oceania vs. rest of the world

Enrollment of patients with Anatomic Stage Group II is capped at approximately 2,000 patients.

The trial will include screening, treatment, and follow up phases. The trial includes an exploratory component that requires collection of tumor and blood samples (except for patients enrolled in China).

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Faktiske)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
5101

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Fase 3

Udvidet adgang

Udvidet adgang

En måde for patienter med alvorlige sygdomme eller tilstande, som ikke kan deltage i et klinisk forsøg, til at få adgang til et medicinsk produkt, der ikke er godkendt af U.S. Food and Drug Administration (FDA). Kaldes også medfølende brug. Der er forskellige udvidede adgangstyper.
Ledig

Ledig

  • Tilgængelig: Udvidet adgang er i øjeblikket tilgængelig for denne forsøgsbehandling, og patienter, der ikke er deltagere i den kliniske undersøgelse, kan muligvis få adgang til lægemidlet, det biologiske eller medicinske udstyr undersøgt.
  • Ikke længere tilgængelig: Udvidet adgang var tilgængelig for denne intervention tidligere, men er ikke tilgængelig i øjeblikket og vil ikke være tilgængelig i fremtiden.
  • Midlertidigt ikke tilgængelig: Udvidet adgang er i øjeblikket ikke tilgængelig for denne intervention, men forventes at være tilgængelig i fremtiden.
  • Godkendt til markedsføring: Interventionen er blevet godkendt af U.S. Food and Drug Administration til brug for offentligheden.
 uden for det kliniske forsøg. Se udvidet adgangsregistrering.

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • CABA, Argentina, C1419AHN
        • Novartis Investigative Site
      • Córdoba, Argentina, X5004FHP
        • Novartis Investigative Site
      • La Rioja, Argentina, 5300
        • Novartis Investigative Site
      • San Salvador de Jujuy, Argentina, Y4600EHA
        • Novartis Investigative Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000
        • Novartis Investigative Site
    • Sante Fe
      • Rosario, Sante Fe, Argentina, S200KZE
        • Novartis Investigative Site
    • Tucumán Province
      • San Miguel Tucuman, Tucumán Province, Argentina, T4000IAK
        • Novartis Investigative Site
    • Viedma
      • Rio Negro, Viedma, Argentina, 8500
        • Novartis Investigative Site
  • Australien
      • Liverpool, Australien, 2170
        • Novartis Investigative Site
    • New South Wales
      • Campbelltown, New South Wales, Australien, 2560
        • Novartis Investigative Site
      • Coffs Harbour, New South Wales, Australien, 2450
        • Novartis Investigative Site
      • Darlinghurst, New South Wales, Australien, 2010
        • Novartis Investigative Site
      • Kingswood, New South Wales, Australien, 2747
        • Novartis Investigative Site
      • Kogarah, New South Wales, Australien, 2217
        • Novartis Investigative Site
      • North Ryde, New South Wales, Australien, 2109
        • Novartis Investigative Site
      • St Leonards, New South Wales, Australien, 2065
        • Novartis Investigative Site
      • Wahroonga, New South Wales, Australien, 2076
        • Novartis Investigative Site
      • Westmead, New South Wales, Australien, 2145
        • Novartis Investigative Site
    • Queensland
      • Auchenflower, Queensland, Australien, 4066
        • Novartis Investigative Site
      • Birtinya, Queensland, Australien, 4575
        • Novartis Investigative Site
      • Wooloongabba, Queensland, Australien, 4102
        • Novartis Investigative Site
    • South Australia
      • Bedford Park, South Australia, Australien, 5041
        • Novartis Investigative Site
    • Victoria
      • Bendigo, Victoria, Australien, 3550
        • Novartis Investigative Site
      • East Melbourne, Victoria, Australien, 3002
        • Novartis Investigative Site
      • Epping, Victoria, Australien, 3076
        • Novartis Investigative Site
      • Fitzroy, Victoria, Australien, 3065
        • Novartis Investigative Site
      • Franston, Victoria, Australien, 3199
        • Novartis Investigative Site
      • Heidelberg, Victoria, Australien, 3084
        • Novartis Investigative Site
      • Melbourne, Victoria, Australien, 3000
        • Novartis Investigative Site
      • Shepparton, Victoria, Australien, 3630
        • Novartis Investigative Site
    • Western Australia
      • Murdoch, Western Australia, Australien, 6150
        • Novartis Investigative Site
      • Nedlands, Western Australia, Australien, 6009
        • Novartis Investigative Site
  • Belgien
      • Brussels, Belgien, 1200
        • Novartis Investigative Site
      • Brussels, Belgien, 1000
        • Novartis Investigative Site
      • Charleroi, Belgien, 6000
        • Novartis Investigative Site
      • Edegem, Belgien, 2650
        • Novartis Investigative Site
      • Jette, Belgien, 1090
        • Novartis Investigative Site
      • Libramont, Belgien, 6800
        • Novartis Investigative Site
      • Liège, Belgien, 4000
        • Novartis Investigative Site
      • Namur, Belgien, 5000
        • Novartis Investigative Site
      • Wilrijk, Belgien, 2610
        • Novartis Investigative Site
      • Yvoir, Belgien, 5530
        • Novartis Investigative Site
    • Limburg
      • Hasselt, Limburg, Belgien, 3500
        • Novartis Investigative Site
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgien, 3000
        • Novartis Investigative Site
  • Brasilien
      • Caxias do Sul, Brasilien, 95070-560
        • Novartis Investigative Site
      • Passo Fundo, Brasilien, 99010-080
        • Novartis Investigative Site
      • Piracicaba, Brasilien, 13419-155
        • Novartis Investigative Site
      • Recife, Brasilien, 50040-000
        • Novartis Investigative Site
      • Rio de Janeiro, Brasilien, 20560-120
        • Novartis Investigative Site
      • Salvador, Brasilien, 41810-570
        • Novartis Investigative Site
      • São Paulo, Brasilien, 01255-000
        • Novartis Investigative Site
    • Paraná
      • Londrina, Paraná, Brasilien, 86015-520
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Ijuí, Rio Grande do Sul, Brasilien, 98700-000
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90610-000
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90880-480
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90050-170
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brasilien, 90560-030
        • Novartis Investigative Site
    • São Paulo
      • Barretos, São Paulo, Brasilien, 14784-400
        • Novartis Investigative Site
      • Santo André, São Paulo, Brasilien, 09060-650
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasilien, 04014-002
        • Novartis Investigative Site
      • São Paulo, São Paulo, Brasilien, 01317-000
        • Novartis Investigative Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Novartis Investigative Site
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Novartis Investigative Site
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5L3
        • Novartis Investigative Site
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Novartis Investigative Site
      • Surrey, British Columbia, Canada, V3V 1Z2
        • Novartis Investigative Site
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Novartis Investigative Site
    • Ontario
      • Greater Sudbury, Ontario, Canada, P3E 5J1
        • Novartis Investigative Site
      • Kitchener, Ontario, Canada, N2G 1G3
        • Novartis Investigative Site
      • London, Ontario, Canada, N6A 5W9
        • Novartis Investigative Site
      • Newmarket, Ontario, Canada, J7Y 2P9
        • Novartis Investigative Site
      • Oshawa, Ontario, Canada, L1G 2B9
        • Novartis Investigative Site
      • Sault Ste. Marie, Ontario, Canada, P6B 0A8
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
      • Windsor, Ontario, Canada, N8W 2X3
        • Novartis Investigative Site
    • Quebec
      • Fleurimont, Quebec, Canada, J1H 5N4
        • Novartis Investigative Site
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2W 1T8
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4A 3J1
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H3T 1E2
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1S 4L8
        • Novartis Investigative Site
      • Saint-Jérôme, Quebec, Canada, J7Z 5T3
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • Cardiff, Det Forenede Kongerige, CF14 2TL
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, SE1 9RT
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, SW3 6JJ
        • Novartis Investigative Site
      • London, Det Forenede Kongerige, NW1 2BU
        • Novartis Investigative Site
      • Nottingham, Det Forenede Kongerige, NG5 1PB
        • Novartis Investigative Site
      • Oxford, Det Forenede Kongerige, OX3 7LE
        • Novartis Investigative Site
      • Preston, Det Forenede Kongerige, PR2 9HT
        • Novartis Investigative Site
      • Stoke-on-Trent, Det Forenede Kongerige, ST4 6QG
        • Novartis Investigative Site
    • Cornwall
      • Truro, Cornwall, Det Forenede Kongerige, TR1 3LJ
        • Novartis Investigative Site
    • Surrey
      • Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
        • Novartis Investigative Site
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294-0006
        • University of Alabama at Birmingham-Kirklin Clinic
    • Arizona
      • Goodyear, Arizona, Forenede Stater, 85338
        • Cancer Treatment Centers of America
    • Arkansas
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • St Bernards Medical Center
    • California
      • Bakersfield, California, Forenede Stater, 93309
        • Comprehensive Blood and Cancer
      • Beverly Hills, California, Forenede Stater, 90212
        • UCLA Beverly Hills
      • Burbank, California, Forenede Stater, 91505
        • UCLA Burbank
      • Encino, California, Forenede Stater, 91436
        • Encino Research Center
      • Fullerton, California, Forenede Stater, 92835
        • St. Jude Heritage Medical Group
      • Laguna Hills, California, Forenede Stater, 92653
        • UCLA Hematology Oncology
      • Los Angeles, California, Forenede Stater, 90057
        • Southern CA Oncology Rsrch Alliance
      • Palo Alto, California, Forenede Stater, 94304-1509
        • Stanford University Medical Center
      • Pasadena, California, Forenede Stater, 91105
        • UCLA Pasadena HC Hemato Onco
      • Porter Ranch, California, Forenede Stater, 91326
        • UCLA Porter Ranch Hemato and Onco
      • Redondo Beach, California, Forenede Stater, 90277
        • Cancer Care Associates Medical Grp
      • San Diego, California, Forenede Stater, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, Forenede Stater, 94115
        • UCSF
      • Santa Maria, California, Forenede Stater, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, Forenede Stater, 90404
        • UCLA Santa Monica Hematology Oncology
      • Torrance, California, Forenede Stater, 90509-2910
        • Lundquist Inst BioMed at Harbor
      • Valencia, California, Forenede Stater, 91355
        • UCLA Valencia
      • Van Nuys, California, Forenede Stater, 91405
        • Valley Breast Care
      • Westlake Village, California, Forenede Stater, 91361
        • UCLA Cancer Center Westlake Village
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • University Of Colorado Hospital
      • Denver, Colorado, Forenede Stater, 80218
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Britain, Connecticut, Forenede Stater, 06052
        • Hospital of Central Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School Of Medicine
      • Norwalk, Connecticut, Forenede Stater, 06856
        • Norwalk Hospital
      • Norwich, Connecticut, Forenede Stater, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Florida
      • Fort Lauderdale, Florida, Forenede Stater, 33308
        • Holy Cross Hospital-Ft. Lauderdale
      • Fort Myers, Florida, Forenede Stater, 33901
        • Florida Cancer Specialists
      • Hollywood, Florida, Forenede Stater, 33021
        • Memorial Cancer Institute
      • Jacksonville, Florida, Forenede Stater, 32207
        • Baptist MD Anderson Cancer Center
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
      • Orlando, Florida, Forenede Stater, 32806
        • Orlando Health Clinical Trials
      • St. Petersburg, Florida, Forenede Stater, 33705
        • Florida Cancer Specialists-North
      • Tallahassee, Florida, Forenede Stater, 32308
        • Florida Cancer Specialists Pan
      • West Palm Beach, Florida, Forenede Stater, 33401
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30322
        • Winship Cancer Institute of Emory University
      • Newnan, Georgia, Forenede Stater, 30265
        • Southeastern Regional Medical Center
    • Illinois
      • Zion, Illinois, Forenede Stater, 60099
        • Cancer Treatment Centers of America
    • Indiana
      • New Albany, Indiana, Forenede Stater, 47150
        • Cancer Care Center
    • Kansas
      • Westwood, Kansas, Forenede Stater, 66205
        • University of Kansas Cancer Center
      • Wichita, Kansas, Forenede Stater, 67214-3728
        • Cancer Center of Kansas
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Norton Cancer Institute
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21202
        • Mercy Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan Cancer Center
    • Minnesota
      • Maple Grove, Minnesota, Forenede Stater, 55369
        • Fairview Health Services
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Park Nicollet Institute
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Metro Minnesota CCOP
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64132
        • HCA Midwest Division
      • Kansas City, Missouri, Forenede Stater, 64111
        • Saint Lukes Hospital of Kansas City
      • St Louis, Missouri, Forenede Stater, 63141
        • David C Pratt Cancer Center
    • Montana
      • Billings, Montana, Forenede Stater, 59102
        • St Vincent Frontier Cancer Center
    • Nebraska
      • Grand Island, Nebraska, Forenede Stater, 68803
        • Saint Francis Medical Center
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89052
        • Comprehensive Cancer Cntr Of Nevada
    • New Jersey
      • Livingston, New Jersey, Forenede Stater, 07039
        • Saint Barnabas Medical Center
    • New York
      • New York, New York, Forenede Stater, 10016
        • Perlmutter Cancer Centre
    • North Carolina
      • Asheboro, North Carolina, Forenede Stater, 27204
        • Randolph Medical Associates
      • Greensboro, North Carolina, Forenede Stater, 27403
        • Cone Health Cancer Center
    • Oregon
      • Clackamas, Oregon, Forenede Stater, 97015
        • Kaiser Permanente NW Region
    • Pennsylvania
      • Hershey, Pennsylvania, Forenede Stater, 17033
        • Penn State Hershey Cancer Institute
      • Philadelphia, Pennsylvania, Forenede Stater, 19124
        • Cancer Treatment Centers of America Eastern Regional Medical Center
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • The West Clinic
      • Nashville, Tennessee, Forenede Stater, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, Forenede Stater, 75246
        • Baylor Charles A Sammons Cancer Cnt
      • Fort Worth, Texas, Forenede Stater, 76104
        • Ctr For Cancer And Blood Disorders
      • Houston, Texas, Forenede Stater, 77030
        • MD Anderson Cancer Center University of Texas
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists
    • Virginia
      • Fairfax, Virginia, Forenede Stater, 22031
        • Virginia Cancer Specialists
      • Richmond, Virginia, Forenede Stater, 23230
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792-6164
        • University of Wisconsin Paul P Carbone Comp Cancer Center
  • Frankrig
      • Amiens, Frankrig, 80000
        • Novartis Investigative Site
      • Angers, Frankrig, 49055
        • Novartis Investigative Site
      • Argenteuil, Frankrig, 95107
        • Novartis Investigative Site
      • Avignon, Frankrig, 84082
        • Novartis Investigative Site
      • Besançon, Frankrig, 25030
        • Novartis Investigative Site
      • Bordeaux, Frankrig, 33076
        • Novartis Investigative Site
      • Bron, Frankrig, 69677
        • Novartis Investigative Site
      • Caen, Frankrig, 14021
        • Novartis Investigative Site
      • Le Mans, Frankrig, 72000
        • Novartis Investigative Site
      • Marseille, Frankrig, 13008
        • Novartis Investigative Site
      • Montpellier, Frankrig, 34070
        • Novartis Investigative Site
      • Montpellier, Frankrig, 34298
        • Novartis Investigative Site
      • Nantes, Frankrig, 44202
        • Novartis Investigative Site
      • Paris, Frankrig, 75231
        • Novartis Investigative Site
      • Paris, Frankrig, 75013
        • Novartis Investigative Site
      • Paris, Frankrig, 75970
        • Novartis Investigative Site
      • Paris, Frankrig, 75015
        • Novartis Investigative Site
      • Paris, Frankrig, 75475
        • Novartis Investigative Site
      • Pierre-Bénite, Frankrig, 69495
        • Novartis Investigative Site
      • Rouen, Frankrig, 76038
        • Novartis Investigative Site
      • Saint-Herblain, Frankrig, 44805
        • Novartis Investigative Site
      • Strasbourg, Frankrig, 67085
        • Novartis Investigative Site
      • Toulouse, Frankrig, 31059
        • Novartis Investigative Site
      • Vandœuvre-lès-Nancy, Frankrig, 54519
        • Novartis Investigative Site
      • Villejuif, Frankrig, 94800
        • Novartis Investigative Site
    • Alpes Maritimes
      • Nice, Alpes Maritimes, Frankrig, 06189
        • Novartis Investigative Site
    • Cote D Or
      • Dijon, Cote D Or, Frankrig, 21034
        • Novartis Investigative Site
    • Haute Vienne
      • Limoges, Haute Vienne, Frankrig, 87000
        • Novartis Investigative Site
    • Hauts De Seine
      • Saint-Cloud, Hauts De Seine, Frankrig, 92210
        • Novartis Investigative Site
    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, Frankrig, 35062
        • Novartis Investigative Site
    • Isere
      • Grenoble, Isere, Frankrig, 38028
        • Novartis Investigative Site
    • Rhone
      • Lyon, Rhone, Frankrig, 69004
        • Novartis Investigative Site
  • Irland
      • County Limerick, Irland, V94 F858
        • Novartis Investigative Site
      • Dublin, Irland, D03 VX82
        • Novartis Investigative Site
      • Dublin, Irland, D04 T6F4
        • Novartis Investigative Site
      • Dublin, Irland, D07 R2WY
        • Novartis Investigative Site
      • Dublin, Irland, D07 WKW8
        • Novartis Investigative Site
      • Dublin, Irland, D09 T974
        • Novartis Investigative Site
      • Waterford, Irland, X91 ER8E
        • Novartis Investigative Site
    • Cork
      • Wilton, Cork, Irland, T12 DC4A
        • Novartis Investigative Site
  • Italien
      • Naples, Italien, 80131
        • Novartis Investigative Site
    • AN
      • Ancona, AN, Italien, 60020
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italien, 24127
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italien, 40138
        • Novartis Investigative Site
    • CT
      • Misterbianco, CT, Italien, 95045
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italien, 20133
        • Novartis Investigative Site
      • Rozzano, MI, Italien, 20089
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italien, 90146
        • Novartis Investigative Site
    • PN
      • Aviano, PN, Italien, 33081
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italien, 00128
        • Novartis Investigative Site
    • TO
      • Candiolo, TO, Italien, 10060
        • Novartis Investigative Site
  • Kina
      • Beijing, Kina, 100021
        • Novartis Investigative Site
      • Chongqing, Kina, 400016
        • Novartis Investigative Site
      • Shanghai, Kina, 200032
        • Novartis Investigative Site
      • Tianjin, Kina, 300480
        • Novartis Investigative Site
      • Zhenjiang, Kina, 310009
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510000
        • Novartis Investigative Site
    • Hebei
      • Shijiazhuang, Hebei, Kina, 050011
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150081
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, Kina, 450008
        • Novartis Investigative Site
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210029
        • Novartis Investigative Site
      • Suzhou, Jiangsu, Kina, 215004
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, Kina, 130021
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
        • Novartis Investigative Site
  • Polen
      • Bialystok, Polen, 15-027
        • Novartis Investigative Site
      • Gdynia, Polen, 81-519
        • Novartis Investigative Site
      • Gliwice, Polen, 44-101
        • Novartis Investigative Site
      • Grudziądz, Polen, 86-300
        • Novartis Investigative Site
      • Krakow, Polen, 31-501
        • Novartis Investigative Site
      • Lodz, Polen, 90-338
        • Novartis Investigative Site
      • Lublin, Polen, 20-090
        • Novartis Investigative Site
      • Opole, Polen, 45-054
        • Novartis Investigative Site
      • Ostrołęka, Polen, 07-410
        • Novartis Investigative Site
      • Otwock, Polen, 05-400
        • Novartis Investigative Site
      • Wieliszew, Polen, 05-135
        • Novartis Investigative Site
      • Wroclaw, Polen, 02-781
        • Novartis Investigative Site
    • Ul Roentgena 5
      • Warsaw, Ul Roentgena 5, Polen, 02-781
        • Novartis Investigative Site
  • Rumænien
      • Bucharest, Rumænien, 011171
        • Novartis Investigative Site
      • Timișoara, Rumænien, 300425
        • Novartis Investigative Site
    • Cluj
      • Cluj-Napoca, Cluj, Rumænien, 400015
        • Novartis Investigative Site
    • Dolj
      • Craiova, Dolj, Rumænien, 200347
        • Novartis Investigative Site
      • Craiova, Dolj, Rumænien, 200535
        • Novartis Investigative Site
  • Rusland
      • Chelyabinsk, Rusland, 454087
        • Novartis Investigative Site
      • Kostroma, Rusland, 156005
        • Novartis Investigative Site
      • Krasnoyarsk, Rusland, 660022
        • Novartis Investigative Site
      • Moscow, Rusland, 143423
        • Novartis Investigative Site
      • Moscow, Rusland, 115522
        • Novartis Investigative Site
      • Moscow, Rusland, 111123
        • Novartis Investigative Site
      • Nizhny Novgorod, Rusland, 603137
        • Novartis Investigative Site
      • Novosibirsk, Rusland, 630000
        • Novartis Investigative Site
      • Obninsk, Rusland, 249036
        • Novartis Investigative Site
      • Omsk, Rusland, 644013
        • Novartis Investigative Site
      • Orenburg, Rusland, 460021
        • Novartis Investigative Site
      • Rostov-on-Don, Rusland, 344037
        • Novartis Investigative Site
      • Ryazan, Rusland, 390011
        • Novartis Investigative Site
      • Saint Petersburg, Rusland, 197758
        • Novartis Investigative Site
      • Saint Petersburg, Rusland, 198255
        • Novartis Investigative Site
      • Saint Petersburg, Rusland, 191104
        • Novartis Investigative Site
      • Tyumen, Rusland, 625041
        • Novartis Investigative Site
      • Ufa, Rusland, 450054
        • Novartis Investigative Site
      • Yaroslavl, Rusland, 150054
        • Novartis Investigative Site
    • Russian Federation
      • Kazan', Russian Federation, Rusland, 420029
        • Novartis Investigative Site
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rusland, 195271
        • Novartis Investigative Site
  • Spanien
      • A Coruña, Spanien, 15009
        • Novartis Investigative Site
      • A Coruña, Spanien, 15006
        • Novartis Investigative Site
      • Barcelona, Spanien, 08035
        • Novartis Investigative Site
      • Barcelona, Spanien, 08036
        • Novartis Investigative Site
      • Burgos, Spanien, 09006
        • Novartis Investigative Site
      • Castellon, Spanien, 12002
        • Novartis Investigative Site
      • Córdoba, Spanien, 14004
        • Novartis Investigative Site
      • Girona, Spanien, 17007
        • Novartis Investigative Site
      • Granada, Spanien, 18016
        • Novartis Investigative Site
      • Las Palmas GC, Spanien, 35010
        • Novartis Investigative Site
      • Madrid, Spanien, 28034
        • Novartis Investigative Site
      • Madrid, Spanien, 28033
        • Novartis Investigative Site
      • Madrid, Spanien, 28040
        • Novartis Investigative Site
      • Madrid, Spanien, 28009
        • Novartis Investigative Site
      • Madrid, Spanien, 28222
        • Novartis Investigative Site
      • Murcia, Spanien, 30008
        • Novartis Investigative Site
      • Málaga, Spanien, 29010
        • Novartis Investigative Site
      • Salamanca, Spanien, 37007
        • Novartis Investigative Site
      • Seville, Spanien, 41009
        • Novartis Investigative Site
      • Seville, Spanien, 41013
        • Novartis Investigative Site
      • Valencia, Spanien, 46014
        • Novartis Investigative Site
      • Valencia, Spanien, 46010
        • Novartis Investigative Site
      • Zaragoza, Spanien, 50009
        • Novartis Investigative Site
    • Alicante
      • Elche, Alicante, Spanien, 03203
        • Novartis Investigative Site
    • Andalusia
      • Granada, Andalusia, Spanien, 18014
        • Novartis Investigative Site
      • Huelva, Andalusia, Spanien, 21005
        • Novartis Investigative Site
      • Jaén, Andalusia, Spanien, 23007
        • Novartis Investigative Site
    • Araba
      • Vitoria-Gasteiz, Araba, Spanien, 01009
        • Novartis Investigative Site
    • Barcelona
      • Badalona, Barcelona, Spanien, 08916
        • Novartis Investigative Site
      • L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
        • Novartis Investigative Site
      • Manresa, Barcelona, Spanien, 08242
        • Novartis Investigative Site
      • Sabadell, Barcelona, Spanien, 08208
        • Novartis Investigative Site
    • Bizkaia
      • Bilbao, Bizkaia, Spanien, 48013
        • Novartis Investigative Site
    • Extremadura
      • Badajoz, Extremadura, Spanien, 06080
        • Novartis Investigative Site
      • Cáceres, Extremadura, Spanien, 10003
        • Novartis Investigative Site
    • Galicia
      • Lugo, Galicia, Spanien, 27003
        • Novartis Investigative Site
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spanien, 20014
        • Novartis Investigative Site
    • Madrid
      • Fuenlabrada, Madrid, Spanien, 28942
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, Spanien, 30120
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Novartis Investigative Site
    • Pontevedra
      • Vigo, Pontevedra, Spanien, 36212
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spanien, 38320
        • Novartis Investigative Site
    • Valencia
      • Alicante, Valencia, Spanien, 03550
        • Novartis Investigative Site
      • Valencia, Valencia, Spanien, 46009
        • Novartis Investigative Site
  • Sydkorea
      • Incheon, Sydkorea, 22332
        • Novartis Investigative Site
      • Incheon, Sydkorea, 21565
        • Novartis Investigative Site
      • Seongnam Gyeonggi, Sydkorea, 13496
        • Novartis Investigative Site
      • Seoul, Sydkorea, 03080
        • Novartis Investigative Site
      • Seoul, Sydkorea, 05505
        • Novartis Investigative Site
      • Seoul, Sydkorea, 03722
        • Novartis Investigative Site
      • Seoul, Sydkorea, 06351
        • Novartis Investigative Site
      • Seoul, Sydkorea, 06591
        • Novartis Investigative Site
      • Ulsan, Sydkorea, 44033
        • Novartis Investigative Site
    • Daegu
      • Seoul, Daegu, Sydkorea, 41404
        • Novartis Investigative Site
    • Gangwon-do
      • Wŏnju, Gangwon-do, Sydkorea, 26426
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bundang Gu, Gyeonggi-do, Sydkorea, 13620
        • Novartis Investigative Site
      • Suwon, Gyeonggi-do, Sydkorea, 16499
        • Novartis Investigative Site
    • Korea
      • Gyeonggi-do, Korea, Sydkorea, 10408
        • Novartis Investigative Site
      • Seoul, Korea, Sydkorea, 02841
        • Novartis Investigative Site
    • North Chungcheong
      • Cheongju-si, North Chungcheong, Sydkorea, 28644
        • Novartis Investigative Site
    • Yangcheon Gu
      • Seoul, Yangcheon Gu, Sydkorea, 07985
        • Novartis Investigative Site
  • Taiwan
      • Changhua, Taiwan, 50006
        • Novartis Investigative Site
      • Taichung, Taiwan, 40447
        • Novartis Investigative Site
      • Taichung, Taiwan, 407219
        • Novartis Investigative Site
      • Tainan, Taiwan, 704302
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
      • Taipei, Taiwan, 10449
        • Novartis Investigative Site
      • Taipei, Taiwan, 103616
        • Novartis Investigative Site
      • Taoyuan, Taiwan, 33305
        • Novartis Investigative Site
  • Tyskland
      • Augsburg, Tyskland, 86150
        • Novartis Investigative Site
      • Bad Liebenwerda, Tyskland, 04924
        • Novartis Investigative Site
      • Berlin, Tyskland, 13125
        • Novartis Investigative Site
      • Bonn, Tyskland, 53111
        • Novartis Investigative Site
      • Bottrop, Tyskland, 46236
        • Novartis Investigative Site
      • Erlangen, Tyskland, 91054
        • Novartis Investigative Site
      • Essen, Tyskland, 45147
        • Novartis Investigative Site
      • Hamburg, Tyskland, 20357
        • Novartis Investigative Site
      • Kiel, Tyskland, 24105
        • Novartis Investigative Site
      • Mainz, Tyskland, 55131
        • Novartis Investigative Site
      • Münster, Tyskland, 48149
        • Novartis Investigative Site
      • Regensburg, Tyskland, 93053
        • Novartis Investigative Site
      • Schweinfurt, Tyskland, 97422
        • Novartis Investigative Site
      • Tübingen, Tyskland, 72076
        • Novartis Investigative Site
      • Ulm, Tyskland, 89081
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Ravensburg, Baden-Wurttemberg, Tyskland, 88212
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Tyskland, 81377
        • Novartis Investigative Site
      • Munich, Bavaria, Tyskland, 80637
        • Novartis Investigative Site
      • Munich, Bavaria, Tyskland, 81675
        • Novartis Investigative Site
      • Würzburg, Bavaria, Tyskland, 97080
        • Novartis Investigative Site
    • Brandenburg
      • Cottbus, Brandenburg, Tyskland, 03048
        • Novartis Investigative Site
    • Hesse
      • Frankfurt am Main, Hesse, Tyskland, 60431
        • Novartis Investigative Site
    • Lower Saxony
      • Georgsmarienhütte, Lower Saxony, Tyskland, 49124
        • Novartis Investigative Site
      • Hanover, Lower Saxony, Tyskland, 30177
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Tyskland, 45136
        • Novartis Investigative Site
      • Mönchengladbach, North Rhine-Westphalia, Tyskland, 41061
        • Novartis Investigative Site
      • Velbert, North Rhine-Westphalia, Tyskland, 42551
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Tyskland, 01307
        • Novartis Investigative Site
  • Ungarn
      • Budapest, Ungarn, 1032
        • Novartis Investigative Site
      • Budapest, Ungarn, 1145
        • Novartis Investigative Site
      • Budapest, Ungarn, 1083
        • Novartis Investigative Site
      • Kecskemét, Ungarn, 6001
        • Novartis Investigative Site
      • Szeged, Ungarn, 6725
        • Novartis Investigative Site
      • Szekszárd, Ungarn, 7100
        • Novartis Investigative Site
      • Szombathely, Ungarn, 9700
        • Novartis Investigative Site
      • Tatabánya, Ungarn, 2800
        • Novartis Investigative Site
    • Baranya
      • Pécs, Baranya, Ungarn, 7623
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Ungarn, 4032
        • Novartis Investigative Site
    • Zala County
      • Zalaegerszeg, Zala County, Ungarn, 8900
        • Novartis Investigative Site
  • Østrig
      • Graz, Østrig, 8036
        • Novartis Investigative Site
      • Linz, Østrig, 4020
        • Novartis Investigative Site
      • Salzburg, Østrig, 5020
        • Novartis Investigative Site
      • Vienna, Østrig, 1090
        • Novartis Investigative Site
    • Tyrol
      • Innsbruck, Tyrol, Østrig, 6020
        • Novartis Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år til 100 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria

  1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure.

  2. Patient is ≥ 18 years-old at the time of PICF signature.

  3. Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.

    Postmenopausal status is defined as:

    • Patient underwent bilateral oophorectomy, or
    • Age ≥ 60 years, or
    • Age < 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifene or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges.
    • If taking tamoxifen or toremifene and age <60 years, then FSH and plasma estradiol level in postmenopausal ranges.

    Notes

    • In women who are premenopausal at the beginning of adjuvant chemotherapy, amenorrhea is not a reliable indicator of menopausal status as ovarian function may still be intact or resume despite anovulation/amenorrhea. For these women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol per local clinical guidelines are required for determination of postmenopausal status.
    • All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial.

  4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis (i.e. date of the pathology report that confirmed the BC diagnosis) within 18 months prior to randomization. Patient with a multicentric and/or multifocal tumor is eligible if all histopathologically examined lesions meet the pathologic criteria in inclusion criteria 5 and 6.

  5. Patient has breast cancer that is positive for ER and/or PgR according to the local laboratory as determined on the most recently analyzed tissue sample.

  6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required to confirm the HER2-negative status (based on the most recently analyzed tissue sample tested by a local laboratory).

  7. Patient (except those enrolled in China) has available archival tumor tissue from the surgical specimen, for submission to a central laboratory (Note: in patients that underwent neoadjuvant systemic therapy and had a pathologic complete response, archival tumor tissue at the time of the initial diagnosis or before the administration of neoadjuvant therapy is mandatory).

  8. Patient, after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories:

    • Anatomic Stage Group III, or
    • Anatomic Stage Group IIB, or
    • Anatomic Stage Group IIA (subset)

    Notes:

    • For patients whose tumors are Anatomic Stage IIA, N0:
    • If Grade is 1 or unknown (Gx), patient is not eligible.
    • If Grade 2, the gene expression test results (by Oncotype DX, Prosigna/PAM50, MammaPrint or EndoPredict EPclin) or Ki67 levels should be used if obtained as per local practice (i.e. are not mandatory for the purpose of the trial). Results must be available at screening.
    • Patients that received neoadjuvant treatment must meet the above criteria (for stage, and if Stage IIA, N0, also for grade and Ki67 or gene expression test) in any presurgical staging/sample and/or in the surgical specimen.
    • Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND is the preferred method for axillary lymph node staging, however SLN dissection can be used to determine the N category in the following cases:
    • No metastasis in SLN (patient is considered as pN0).
    • Only micrometastasis in SLN (patient is considered as pN1mi).
    • Patients with T1-2 and no clinically-evident nodes prior to surgery, no neoadjuvant chemotherapy, at least one macrometastasis in 1 or 2 SLNs, no matted nodes or gross extranodal disease at the time of SLN dissection (patient is considered as pN1).

    In all other cases, ALND is required to determine the N category.

  9. If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines, prior to screening.

  10. If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines, prior to screening.

  11. Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years (since randomization date) or more.

  12. Patient may have already received any standard neoadjuvant and/or adjuvant ET at the time of PICF signature, but randomization should occur within 12 months of the initial start date of ET. Ovarian suppression or short term ET for fertility preservation is not considered neoadjuvant/adjuvant ET. If patient was receiving tamoxifen or toremifene as adjuvant ET, a washout period of 5 half-lives (i.e. 35 days) prior to randomization is required (during that period patient can take AI).

  13. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

  14. Patient has adequate bone marrow and organ function as defined by the following local laboratory values:

    • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L
    • Platelets ≥ 100 × 109/L
    • Hemoglobin ≥ 9.0 g/dL
    • Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 according to the Modification of Diet in Renal Disease (MDRD) formula
    • Alanine transaminase (ALT) < 2.5 × Upper Limit Normal (ULN)
    • Aspartate transaminase (AST) < 2.5 × ULN
    • Total serum bilirubin < ULN; or total bilirubin ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN in patients with well documented Gilbert's Syndrome
    • International normalized ratio (INR) ≤ 1.5 (unless the patient is receiving anticoagulants and the INR is within the therapeutic range of intended use for that anticoagulant within 7 days prior to randomization)
    • Patient must have the following laboratory values within normal limits or corrected to within normal limits with supplements (the local laboratory value should be documented within normal limits after the correction) before randomization:
    • Potassium
    • Magnesium
    • Total Calcium (corrected for serum albumin)

  15. Standard 12-lead ECG values assessed by a central laboratory, as:

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

  16. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.

  17. Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant (see Inclusion Criterion #18 for additional information), must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization.

  18. Women of CBP must be willing to use highly effective methods of contraception. Contraception must continue during the trial treatment and for 21 days after stopping the treatment. Highly effective contraception methods include:

    • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking trial treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    • Male partner sterilization (at least 6 months prior to randomization). For female patients on the trial the vasectomized male partner should be the sole partner for that patient. If vasectomy of the male partner is the highly effective method of contraception chosen, the success of the vasectomy should be medically confirmed according to local practice.
    • Placement of an intrauterine device (IUD).

Notes:

  • Use of oral (estrogen and progesterone), transdermal, injected, implanted, hormone containing intrauterine system or any other hormonal method of contraception is not allowed in this trial.
  • Women are considered of CBP unless: they have had ≥ 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks prior to randomization. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment she is considered not of CBP.
  • After the end of trial treatment, patients should use effective contraception according to local guidelines.

Exclusion Criteria

  1. Patient has received any CDK4/6 inhibitor.

  2. Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization. Patient is concurrently using hormone replacement therapy.

  3. Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.

  4. Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy).

  5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.

  6. Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET (see Inclusion Criterion #12).

  7. Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization.

  8. Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03 Grade ≤1 at day of randomization. Exceptions to this criterion: patients with any grade of alopecia, amenorrhea, grade 2 neuropathy are allowed to enter the trial or other toxicities not considered a safety risk for the patient as per Investigator's discretion, are allowed to enter the trial.

  9. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization. Note: Patients with adequately treated, basal or squamous cell skin carcinoma or curatively resected cervical cancer in situ are eligible.

  10. Patient has known history of human immunodeficiency virus (HIV) infection (testing is not mandatory, unless required by local regulation).

  11. Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (testing is not mandatory, unless required by local regulation).

  12. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following:

    • History of documented myocardial infarction (MI), angina pectoris, symptomatic pericarditis, or coronary artery bypass graft within 6 months prior to trial entry.
    • Documented cardiomyopathy.
    • Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) (testing not mandatory)
    • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
    • Risk factors for Torsades de Pointes (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
    • Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause TdP that cannot be discontinued or replaced by safe alternative medication (e.g. within 5 half-lives or 7 days prior to starting trial treatment).
    • Inability to determine the QTcF interval.
    • Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade Atrioventricular (AV) block (e.g. bifascicular block, Mobitz type II and third degree AV block).
    • Uncontrolled arterial hypertension with systolic blood pressure > 160 mmHg.

  13. Patient is currently receiving any of the following substances within 7 days before randomization:

    • Concomitant medications, herbal supplements, and/or fruits (e.g. grapefruit, pummellos, starfruit, Seville oranges) and their juices that are known as strong inhibitors or inducers of CYP3A4/5
    • Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5

  14. Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment, or has not fully recovered from side effects of such treatment.

    Note: The following uses of corticosteroids are permitted: a short duration (<5 days) of systemic corticosteroids; any duration of topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airways diseases), eye drops or local injections (e.g. intra-articular).

  15. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the oral trial treatments (e.g. uncontrolled ulcerative diseases, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, or small bowel resection).

  16. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic anti-bacterial therapy, etc.) or limit life expectancy to ≤5 years.

  17. Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Medical Monitor is required to establish eligibility.

  18. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Ribociclib + Endocrine Therapy (ET)

Eligible participants will receive Ribociclib 400 mg once daily on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (Days 22 to 28).

And

Endocrine Therapy (ET) consisting of:

  • For postmenopausal women:

    - Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.

  • For premenopausal women and men:

    • Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with:
    • Goserelin 3.6 mg subcutaneously once every 4 weeks.
Medicin: Ribociclib

Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle

Andre navne:
  • LEE011
Andet: Endocrine Therapy (ET)

Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information
Aktiv komparator: Endocrine Therapy (ET)

Eligible participants will receive Endocrine Therapy (ET) consisting of:

  • For postmenopausal women:

    - Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.

  • For premenopausal women and men:

    • Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, combined with:
    • Goserelin 3.6 mg subcutaneously once every 4 weeks.
Andet: Endocrine Therapy (ET)

Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Invasive Disease-Free Survival (iDFS)
Tidsramme: Up to approximately 139 months

Invasive Disease-Free Survival (iDFS) is defined as the time from the date of randomization to the date of the first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed locally using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
Up to approximately 139 months

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recurrence-free survival (RFS)
Tidsramme: Up to approximately 139 months

Recurrence-free survival (RFS) is defined as the time from date of randomization to date of first event of local invasive breast recurrence, regional invasive recurrence, distant recurrence, or death (any cause) and will be assessed using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
Up to approximately 139 months
Distant disease-free survival (DDFS)
Tidsramme: Up to approximately 139 months

Distant disease-free survival (DDFS) is defined as the time from date of randomization to date of first event of distant recurrence, death (any cause), or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin) and will be assessed using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials).
Up to approximately 139 months
Overall Survival (OS)
Tidsramme: Up to approximately 139 months

Overall Survival (OS) is defined as the time from date of randomization to date of death due to any cause.
Up to approximately 139 months
Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30
Tidsramme: Up to approximately 139 months

The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Up to approximately 139 months
Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30
Tidsramme: Up to approximately 139 months

The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Up to approximately 139 months
Trough Concentration on Day 15 (Ctrough,D1) of ribociclib
Tidsramme: Cycle 1 Day 15 (0/Pre-dose, 2 and 4 hours post-dose)

Venous whole blood samples will be collected for activity-based pharmacokinetics characterization in a subset of participants. Ctrough,D15 of ribociclib will be listed and summarized using descriptive statistics.
Cycle 1 Day 15 (0/Pre-dose, 2 and 4 hours post-dose)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Novartis Pharmaceuticals

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Translational Research in Oncology

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studieleder: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
7. december 2018

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
29. maj 2030

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
29. maj 2030

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
21. september 2018

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
7. oktober 2018

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
10. oktober 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
9. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
8. oktober 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • CLEE011O12301C
  • 2023-510357-42-00 (Registry Identifier: EU CT Number)
  • TRIO033 (Anden identifikator: Translational Research in Oncology)
  • 2023 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Cookieindstillinger

Vi bruger cookies for at sikre, at vi giver dig den bedste oplevelse på vores hjemmeside. For flere detaljer skal du læse omhyggeligt vores Politik om beskyttelse af personlige oplysninger og cookies. ...>>>Du kan når som helst ændre dine præferencer eller trække dit samtykke tilbage ved at slette cookies fra din hjemmeside eller computer som beskrevet i politikken. Accepter det og vælg dine præferencer ved at markere de tilsvarende felter i afsnittet "Administrer indstillinger" nedenfor. Læs vores servicevilkår omhyggeligt, inden du fortsætter med at bruge nogen del af dette websted.
«Administrer indstillinger