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Испытание по оценке эффективности и безопасности рибоциклиба при эндокринной терапии в качестве адъювантной терапии у пациентов с ранним раком молочной железы HR+/HER2- (NATALEE)

8 октября 2026 г. обновлено: Novartis Pharmaceuticals

Многоцентровое рандомизированное открытое исследование фазы III для оценки эффективности и безопасности рибоциклиба в сочетании с эндокринной терапией в качестве адъювантного лечения у пациентов с гормон-рецептор-положительным и HER2-отрицательным ранним раком молочной железы (новое адъювантное исследование с рибоциклибом [LEE011] : НАТАЛИ)

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).

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Подробное описание

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).

Тип исследования

Интервенционный

Регистрация (Действительный)

5101

Фаза

  • Фаза 3

Расширенный доступ

Доступный вне клинических испытаний. См. запись расширенного доступа.

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 100 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Лекарство: Ribociclib

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

Другие имена:
  • LEE011
Другой: Endocrine Therapy (ET)

Endocrine Therapy (ET) will be administered according to the local clinical guidelines and current local prescribing information
Активный компаратор: 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.
Другой: Endocrine Therapy (ET)

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Invasive Disease-Free Survival (iDFS)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Recurrence-free survival (RFS)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Novartis Pharmaceuticals

Соавторы

Translational Research in Oncology

Следователи

  • Директор по исследованиям: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Общие публикации

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

7 декабря 2018 г.

Первичное завершение (Оцененный)

29 мая 2030 г.

Завершение исследования (Оцененный)

29 мая 2030 г.

Даты регистрации исследования

Первый отправленный

21 сентября 2018 г.

Впервые представлено, что соответствует критериям контроля качества

7 октября 2018 г.

Первый опубликованный (Действительный)

10 октября 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

9 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

8 октября 2026 г.

Последняя проверка

1 октября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • CLEE011O12301C
  • 2023-510357-42-00 (Идентификатор реестра: EU CT Number)
  • TRIO033 (Другой идентификатор: Translational Research in Oncology)
  • 2023 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана 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

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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