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Uno studio per valutare l'efficacia e la sicurezza di ribociclib con terapia endocrina come trattamento adiuvante in pazienti con carcinoma mammario in fase iniziale HR+/HER2- (NATALEE)

8 ottobre 2026 aggiornato da: Novartis Pharmaceuticals

Uno studio di fase III multicentrico, randomizzato, in aperto per valutare l'efficacia e la sicurezza di ribociclib con terapia endocrina come trattamento adiuvante in pazienti con carcinoma mammario in fase iniziale positivo per i recettori ormonali e HER2 negativo (nuovo studio adiuvante con ribociclib [LEE011] : NATALE)

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).

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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).

Tipo di studio

Interventistico

Iscrizione (Effettivo)

5101

Fase

  • Fase 3

Accesso esteso

A disposizione al di fuori della sperimentazione clinica. Vedi record di accesso esteso.

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • 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
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    • 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
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    • Viedma
      • Rio Negro, Viedma, Argentina, 8500
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  • Australia
      • Liverpool, Australia, 2170
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    • New South Wales
      • Campbelltown, New South Wales, Australia, 2560
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      • Coffs Harbour, New South Wales, Australia, 2450
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      • Darlinghurst, New South Wales, Australia, 2010
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      • Kingswood, New South Wales, Australia, 2747
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      • Kogarah, New South Wales, Australia, 2217
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      • North Ryde, New South Wales, Australia, 2109
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      • St Leonards, New South Wales, Australia, 2065
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      • Wahroonga, New South Wales, Australia, 2076
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      • Westmead, New South Wales, Australia, 2145
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    • Queensland
      • Auchenflower, Queensland, Australia, 4066
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      • Birtinya, Queensland, Australia, 4575
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      • Wooloongabba, Queensland, Australia, 4102
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    • South Australia
      • Bedford Park, South Australia, Australia, 5041
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    • Victoria
      • Bendigo, Victoria, Australia, 3550
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      • East Melbourne, Victoria, Australia, 3002
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      • Epping, Victoria, Australia, 3076
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      • Fitzroy, Victoria, Australia, 3065
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      • Franston, Victoria, Australia, 3199
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      • Heidelberg, Victoria, Australia, 3084
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      • Melbourne, Victoria, Australia, 3000
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      • Shepparton, Victoria, Australia, 3630
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    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
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      • Nedlands, Western Australia, Australia, 6009
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  • Austria
      • Graz, Austria, 8036
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      • Linz, Austria, 4020
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      • Salzburg, Austria, 5020
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      • Vienna, Austria, 1090
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      • Innsbruck, Tyrol, Austria, 6020
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  • Belgio
      • Brussels, Belgio, 1200
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      • Brussels, Belgio, 1000
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      • Charleroi, Belgio, 6000
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      • Edegem, Belgio, 2650
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      • Jette, Belgio, 1090
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      • Liège, Belgio, 4000
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    • Vlaams Brabant
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      • Passo Fundo, Brasile, 99010-080
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  • Cina
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      • Shanghai, Cina, 200032
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      • Guangzhou, Guangdong, Cina, 510000
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    • Hebei
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      • Harbin, Heilongjiang, Cina, 150081
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    • Henan
      • Zhengzhou, Henan, Cina, 450008
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      • Wuhan, Hubei, Cina, 430022
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    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210029
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      • Suzhou, Jiangsu, Cina, 215004
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    • Jilin
      • Changchun, Jilin, Cina, 130021
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    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
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    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310016
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  • Corea del Sud
      • Incheon, Corea del Sud, 22332
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      • Incheon, Corea del Sud, 21565
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      • Seongnam Gyeonggi, Corea del Sud, 13496
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      • Seoul, Corea del Sud, 03080
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      • Seoul, Corea del Sud, 05505
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      • Seoul, Corea del Sud, 03722
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      • Seoul, Corea del Sud, 06351
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      • Seoul, Corea del Sud, 06591
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      • Ulsan, Corea del Sud, 44033
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    • Daegu
      • Seoul, Daegu, Corea del Sud, 41404
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    • Gangwon-do
      • Wŏnju, Gangwon-do, Corea del Sud, 26426
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    • Gyeonggi-do
      • Bundang Gu, Gyeonggi-do, Corea del Sud, 13620
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    • Korea
      • Gyeonggi-do, Korea, Corea del Sud, 10408
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      • Seoul, Korea, Corea del Sud, 02841
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    • North Chungcheong
      • Cheongju-si, North Chungcheong, Corea del Sud, 28644
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    • Yangcheon Gu
      • Seoul, Yangcheon Gu, Corea del Sud, 07985
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  • Francia
      • Amiens, Francia, 80000
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      • Angers, Francia, 49055
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      • Argenteuil, Francia, 95107
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      • Avignon, Francia, 84082
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      • Besançon, Francia, 25030
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      • Bordeaux, Francia, 33076
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      • Bron, Francia, 69677
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      • Caen, Francia, 14021
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      • Le Mans, Francia, 72000
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      • Marseille, Francia, 13008
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      • Montpellier, Francia, 34070
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      • Montpellier, Francia, 34298
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      • Nantes, Francia, 44202
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      • Paris, Francia, 75231
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      • Paris, Francia, 75013
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      • Paris, Francia, 75970
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      • Paris, Francia, 75015
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      • Paris, Francia, 75475
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      • Pierre-Bénite, Francia, 69495
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      • Rouen, Francia, 76038
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      • Saint-Herblain, Francia, 44805
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      • Strasbourg, Francia, 67085
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      • Toulouse, Francia, 31059
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      • Vandœuvre-lès-Nancy, Francia, 54519
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      • Villejuif, Francia, 94800
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    • Alpes Maritimes
      • Nice, Alpes Maritimes, Francia, 06189
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    • Cote D Or
      • Dijon, Cote D Or, Francia, 21034
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    • Haute Vienne
      • Limoges, Haute Vienne, Francia, 87000
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    • Hauts De Seine
      • Saint-Cloud, Hauts De Seine, Francia, 92210
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    • Ille Et Vilaine
      • Rennes, Ille Et Vilaine, Francia, 35062
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    • Isere
      • Grenoble, Isere, Francia, 38028
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    • Rhone
      • Lyon, Rhone, Francia, 69004
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  • Germania
      • Augsburg, Germania, 86150
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      • Bad Liebenwerda, Germania, 04924
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      • Berlin, Germania, 13125
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      • Bonn, Germania, 53111
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      • Bottrop, Germania, 46236
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      • Erlangen, Germania, 91054
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      • Essen, Germania, 45147
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      • Hamburg, Germania, 20357
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      • Kiel, Germania, 24105
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      • Mainz, Germania, 55131
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      • Münster, Germania, 48149
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      • Regensburg, Germania, 93053
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      • Schweinfurt, Germania, 97422
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      • Tübingen, Germania, 72076
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      • Ulm, Germania, 89081
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    • Baden-Wurttemberg
      • Ravensburg, Baden-Wurttemberg, Germania, 88212
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    • Bavaria
      • Munich, Bavaria, Germania, 81377
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      • Munich, Bavaria, Germania, 80637
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      • Munich, Bavaria, Germania, 81675
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    • Brandenburg
      • Cottbus, Brandenburg, Germania, 03048
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    • Hesse
      • Frankfurt am Main, Hesse, Germania, 60431
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    • Lower Saxony
      • Georgsmarienhütte, Lower Saxony, Germania, 49124
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    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germania, 45136
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    • Saxony
      • Dresden, Saxony, Germania, 01307
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  • Irlanda
      • County Limerick, Irlanda, V94 F858
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    • Cork
      • Wilton, Cork, Irlanda, T12 DC4A
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  • Italia
      • Naples, Italia, 80131
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    • AN
      • Ancona, AN, Italia, 60020
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    • BG
      • Bergamo, BG, Italia, 24127
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    • BO
      • Bologna, BO, Italia, 40138
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    • CT
      • Misterbianco, CT, Italia, 95045
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      • Milan, MI, Italia, 20133
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      • Palermo, PA, Italia, 90146
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  • Polonia
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  • Regno Unito
      • Cardiff, Regno Unito, CF14 2TL
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    • Russian Federation
      • Kazan', Russian Federation, Russia, 420029
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      • Saint Petersburg, Sankt-Peterburg, Russia, 195271
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      • Madrid, Spagna, 28222
        • Novartis Investigative Site
      • Murcia, Spagna, 30008
        • Novartis Investigative Site
      • Málaga, Spagna, 29010
        • Novartis Investigative Site
      • Salamanca, Spagna, 37007
        • Novartis Investigative Site
      • Seville, Spagna, 41009
        • Novartis Investigative Site
      • Seville, Spagna, 41013
        • Novartis Investigative Site
      • Valencia, Spagna, 46014
        • Novartis Investigative Site
      • Valencia, Spagna, 46010
        • Novartis Investigative Site
      • Zaragoza, Spagna, 50009
        • Novartis Investigative Site
    • Alicante
      • Elche, Alicante, Spagna, 03203
        • Novartis Investigative Site
    • Andalusia
      • Granada, Andalusia, Spagna, 18014
        • Novartis Investigative Site
      • Huelva, Andalusia, Spagna, 21005
        • Novartis Investigative Site
      • Jaén, Andalusia, Spagna, 23007
        • Novartis Investigative Site
    • Araba
      • Vitoria-Gasteiz, Araba, Spagna, 01009
        • Novartis Investigative Site
    • Barcelona
      • Badalona, Barcelona, Spagna, 08916
        • Novartis Investigative Site
      • L'Hospitalet de Llobregat, Barcelona, Spagna, 08907
        • Novartis Investigative Site
      • Manresa, Barcelona, Spagna, 08242
        • Novartis Investigative Site
      • Sabadell, Barcelona, Spagna, 08208
        • Novartis Investigative Site
    • Bizkaia
      • Bilbao, Bizkaia, Spagna, 48013
        • Novartis Investigative Site
    • Extremadura
      • Badajoz, Extremadura, Spagna, 06080
        • Novartis Investigative Site
      • Cáceres, Extremadura, Spagna, 10003
        • Novartis Investigative Site
    • Galicia
      • Lugo, Galicia, Spagna, 27003
        • Novartis Investigative Site
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spagna, 20014
        • Novartis Investigative Site
    • Madrid
      • Fuenlabrada, Madrid, Spagna, 28942
        • Novartis Investigative Site
    • Murcia
      • El Palmar, Murcia, Spagna, 30120
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spagna, 31008
        • Novartis Investigative Site
    • Pontevedra
      • Vigo, Pontevedra, Spagna, 36212
        • Novartis Investigative Site
    • Santa Cruz De Tenerife
      • San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spagna, 38320
        • Novartis Investigative Site
    • Valencia
      • Alicante, Valencia, Spagna, 03550
        • Novartis Investigative Site
      • Valencia, Valencia, Spagna, 46009
        • Novartis Investigative Site
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35294-0006
        • University of Alabama at Birmingham-Kirklin Clinic
    • Arizona
      • Goodyear, Arizona, Stati Uniti, 85338
        • Cancer Treatment Centers of America
    • Arkansas
      • Jonesboro, Arkansas, Stati Uniti, 72401
        • St Bernards Medical Center
    • California
      • Bakersfield, California, Stati Uniti, 93309
        • Comprehensive Blood and Cancer
      • Beverly Hills, California, Stati Uniti, 90212
        • UCLA Beverly Hills
      • Burbank, California, Stati Uniti, 91505
        • UCLA Burbank
      • Encino, California, Stati Uniti, 91436
        • Encino Research Center
      • Fullerton, California, Stati Uniti, 92835
        • St. Jude Heritage Medical Group
      • Laguna Hills, California, Stati Uniti, 92653
        • UCLA Hematology Oncology
      • Los Angeles, California, Stati Uniti, 90057
        • Southern CA Oncology Rsrch Alliance
      • Palo Alto, California, Stati Uniti, 94304-1509
        • Stanford University Medical Center
      • Pasadena, California, Stati Uniti, 91105
        • UCLA Pasadena HC Hemato Onco
      • Porter Ranch, California, Stati Uniti, 91326
        • UCLA Porter Ranch Hemato and Onco
      • Redondo Beach, California, Stati Uniti, 90277
        • Cancer Care Associates Medical Grp
      • San Diego, California, Stati Uniti, 92123
        • Sharp Memorial Hospital
      • San Francisco, California, Stati Uniti, 94115
        • UCSF
      • Santa Maria, California, Stati Uniti, 93454
        • Central Coast Medical Oncology Corporation
      • Santa Monica, California, Stati Uniti, 90404
        • UCLA Santa Monica Hematology Oncology
      • Torrance, California, Stati Uniti, 90509-2910
        • Lundquist Inst BioMed at Harbor
      • Valencia, California, Stati Uniti, 91355
        • UCLA Valencia
      • Van Nuys, California, Stati Uniti, 91405
        • Valley Breast Care
      • Westlake Village, California, Stati Uniti, 91361
        • UCLA Cancer Center Westlake Village
    • Colorado
      • Aurora, Colorado, Stati Uniti, 80045
        • University Of Colorado Hospital
      • Denver, Colorado, Stati Uniti, 80218
        • Rocky Mountain Cancer Centers
    • Connecticut
      • New Britain, Connecticut, Stati Uniti, 06052
        • Hospital of Central Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Yale University School Of Medicine
      • Norwalk, Connecticut, Stati Uniti, 06856
        • Norwalk Hospital
      • Norwich, Connecticut, Stati Uniti, 06360
        • Eastern Connecticut Hematology and Oncology Associates
    • Florida
      • Fort Lauderdale, Florida, Stati Uniti, 33308
        • Holy Cross Hospital-Ft. Lauderdale
      • Fort Myers, Florida, Stati Uniti, 33901
        • Florida Cancer Specialists
      • Hollywood, Florida, Stati Uniti, 33021
        • Memorial Cancer Institute
      • Jacksonville, Florida, Stati Uniti, 32207
        • Baptist MD Anderson Cancer Center
      • Miami, Florida, Stati Uniti, 33136
        • University of Miami
      • Orlando, Florida, Stati Uniti, 32806
        • Orlando Health Clinical Trials
      • St. Petersburg, Florida, Stati Uniti, 33705
        • Florida Cancer Specialists-North
      • Tallahassee, Florida, Stati Uniti, 32308
        • Florida Cancer Specialists Pan
      • West Palm Beach, Florida, Stati Uniti, 33401
        • Florida Cancer Specialists
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30322
        • Winship Cancer Institute of Emory University
      • Newnan, Georgia, Stati Uniti, 30265
        • Southeastern Regional Medical Center
    • Illinois
      • Zion, Illinois, Stati Uniti, 60099
        • Cancer Treatment Centers of America
    • Indiana
      • New Albany, Indiana, Stati Uniti, 47150
        • Cancer Care Center
    • Kansas
      • Westwood, Kansas, Stati Uniti, 66205
        • University of Kansas Cancer Center
      • Wichita, Kansas, Stati Uniti, 67214-3728
        • Cancer Center of Kansas
    • Kentucky
      • Louisville, Kentucky, Stati Uniti, 40202
        • Norton Cancer Institute
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21202
        • Mercy Medical Center
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan Cancer Center
    • Minnesota
      • Maple Grove, Minnesota, Stati Uniti, 55369
        • Fairview Health Services
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Park Nicollet Institute
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Metro Minnesota CCOP
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64132
        • HCA Midwest Division
      • Kansas City, Missouri, Stati Uniti, 64111
        • Saint Lukes Hospital of Kansas City
      • St Louis, Missouri, Stati Uniti, 63141
        • David C Pratt Cancer Center
    • Montana
      • Billings, Montana, Stati Uniti, 59102
        • St Vincent Frontier Cancer Center
    • Nebraska
      • Grand Island, Nebraska, Stati Uniti, 68803
        • Saint Francis Medical Center
    • Nevada
      • Henderson, Nevada, Stati Uniti, 89052
        • Comprehensive Cancer Cntr Of Nevada
    • New Jersey
      • Livingston, New Jersey, Stati Uniti, 07039
        • Saint Barnabas Medical Center
    • New York
      • New York, New York, Stati Uniti, 10016
        • Perlmutter Cancer Centre
    • North Carolina
      • Asheboro, North Carolina, Stati Uniti, 27204
        • Randolph Medical Associates
      • Greensboro, North Carolina, Stati Uniti, 27403
        • Cone Health Cancer Center
    • Oregon
      • Clackamas, Oregon, Stati Uniti, 97015
        • Kaiser Permanente NW Region
    • Pennsylvania
      • Hershey, Pennsylvania, Stati Uniti, 17033
        • Penn State Hershey Cancer Institute
      • Philadelphia, Pennsylvania, Stati Uniti, 19124
        • Cancer Treatment Centers of America Eastern Regional Medical Center
    • Tennessee
      • Germantown, Tennessee, Stati Uniti, 38138
        • The West Clinic
      • Nashville, Tennessee, Stati Uniti, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, Stati Uniti, 75246
        • Baylor Charles A Sammons Cancer Cnt
      • Fort Worth, Texas, Stati Uniti, 76104
        • Ctr For Cancer And Blood Disorders
      • Houston, Texas, Stati Uniti, 77030
        • MD Anderson Cancer Center University of Texas
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84106
        • Utah Cancer Specialists
    • Virginia
      • Fairfax, Virginia, Stati Uniti, 22031
        • Virginia Cancer Specialists
      • Richmond, Virginia, Stati Uniti, 23230
        • Virginia Cancer Institute
    • Washington
      • Seattle, Washington, Stati Uniti, 98109
        • Fred Hutchinson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792-6164
        • University of Wisconsin Paul P Carbone Comp Cancer Center
  • 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
  • Ungheria
      • Budapest, Ungheria, 1032
        • Novartis Investigative Site
      • Budapest, Ungheria, 1145
        • Novartis Investigative Site
      • Budapest, Ungheria, 1083
        • Novartis Investigative Site
      • Kecskemét, Ungheria, 6001
        • Novartis Investigative Site
      • Szeged, Ungheria, 6725
        • Novartis Investigative Site
      • Szekszárd, Ungheria, 7100
        • Novartis Investigative Site
      • Szombathely, Ungheria, 9700
        • Novartis Investigative Site
      • Tatabánya, Ungheria, 2800
        • Novartis Investigative Site
    • Baranya
      • Pécs, Baranya, Ungheria, 7623
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Ungheria, 4032
        • Novartis Investigative Site
    • Zala County
      • Zalaegerszeg, Zala County, Ungheria, 8900
        • Novartis Investigative Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 100 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: Ribociclib

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

Altri nomi:
  • LEE011
Altro: Endocrine Therapy (ET)

Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information
Comparatore attivo: 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.
Altro: Endocrine Therapy (ET)

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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Invasive Disease-Free Survival (iDFS)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Recurrence-free survival (RFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Novartis Pharmaceuticals

Collaboratori

Translational Research in Oncology

Investigatori

  • Direttore dello studio: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

7 dicembre 2018

Completamento primario (Stimato)

29 maggio 2030

Completamento dello studio (Stimato)

29 maggio 2030

Date di iscrizione allo studio

Primo inviato

21 settembre 2018

Primo inviato che soddisfa i criteri di controllo qualità

7 ottobre 2018

Primo Inserito (Effettivo)

10 ottobre 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CLEE011O12301C
  • 2023-510357-42-00 (Identificatore di registro: EU CT Number)
  • TRIO033 (Altro identificatore: Translational Research in Oncology)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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