A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE)

A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)

Study Overview

• Status: Active, not recruiting
• Conditions: Early Breast Cancer
• Intervention / Treatment: Drug: Ribociclib; Other: Endocrine Therapy

Detailed Description

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.

The trial will include screening, treatment, and follow up phases.

• Study Type: Interventional
• Enrollment (Actual): 5101
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1419AHN
    • Novartis Investigative Site
  • Cordoba, Argentina, X5004FHP
    • Novartis Investigative Site
  • Jujuy, Argentina, 4600
    • Novartis Investigative Site
  • La Rioja, Argentina, 5300
    • Novartis Investigative Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000
      • Novartis Investigative Site
  • Sante Fe
    • Rosario, Sante Fe, Argentina, S200KZE
      • Novartis Investigative Site
  • Tucuman
    • San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
      • Novartis Investigative Site
  • Viedma
    • Rio Negro, Viedma, Argentina, 8500
      • Novartis Investigative Site
• Australia
  • New South Wales
    • Campbelltown, New South Wales, Australia, 2560
      • Novartis Investigative Site
    • Coffs Harbour, New South Wales, Australia, 2450
      • Novartis Investigative Site
    • Darlinghurst, New South Wales, Australia, 2010
      • Novartis Investigative Site
    • Kingswood, New South Wales, Australia, 2747
      • Novartis Investigative Site
    • Kogarah, New South Wales, Australia, 2217
      • Novartis Investigative Site
    • Liverpool, New South Wales, Australia, 2170
      • Novartis Investigative Site
    • North Ryde, New South Wales, Australia, 2109
      • Novartis Investigative Site
    • St Leonards, New South Wales, Australia, 2065
      • Novartis Investigative Site
    • Wahroonga, New South Wales, Australia, 2076
      • Novartis Investigative Site
    • Westmead, New South Wales, Australia, 2145
      • Novartis Investigative Site
  • Queensland
    • Auchenflower, Queensland, Australia, 4066
      • Novartis Investigative Site
    • Birtinya, Queensland, Australia, 4575
      • Novartis Investigative Site
    • Wooloongabba, Queensland, Australia, 4102
      • Novartis Investigative Site
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Novartis Investigative Site
  • Victoria
    • Bendigo, Victoria, Australia, 3550
      • Novartis Investigative Site
    • East Melbourne, Victoria, Australia, 3002
      • Novartis Investigative Site
    • Epping, Victoria, Australia, 3076
      • Novartis Investigative Site
    • Fitzroy, Victoria, Australia, 3065
      • Novartis Investigative Site
    • Franston, Victoria, Australia, 3199
      • Novartis Investigative Site
    • Heidelberg, Victoria, Australia, 3084
      • Novartis Investigative Site
    • Melbourne, Victoria, Australia, 3000
      • Novartis Investigative Site
    • Shepparton, Victoria, Australia, 3630
      • Novartis Investigative Site
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Novartis Investigative Site
    • Nedlands, Western Australia, Australia, 6009
      • Novartis Investigative Site
• Austria
  • Linz, Austria, 4020
    • Novartis Investigative Site
  • Salzburg, Austria, 5020
    • Novartis Investigative Site
  • Wien, Austria, 1090
    • Novartis Investigative Site
  • Styria
    • Graz, Styria, Austria, 8036
      • Novartis Investigative Site
  • Tyrol
    • Innsbruck, Tyrol, Austria, 6020
      • Novartis Investigative Site
• Belgium
  • Bruxelles, Belgium, 1200
    • Novartis Investigative Site
  • Bruxelles, Belgium, 1000
    • Novartis Investigative Site
  • Bruxelles, Belgium, 1090
    • Novartis Investigative Site
  • Charleroi, Belgium, 6000
    • Novartis Investigative Site
  • Hasselt, Belgium, 3500
    • Novartis Investigative Site
  • Leuven, Belgium, 3000
    • Novartis Investigative Site
  • Libramont, Belgium, 6800
    • Novartis Investigative Site
  • Liege, Belgium, 4000
    • Novartis Investigative Site
  • Namur, Belgium, 5000
    • Novartis Investigative Site
  • Wilrijk, Belgium, 2610
    • Novartis Investigative Site
  • Yvoir, Belgium, 5530
    • Novartis Investigative Site
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Novartis Investigative Site
• Brazil
  • Caxias do Sul, Brazil, 95070-560
    • Novartis Investigative Site
  • Passo Fundo, Brazil, 99010-080
    • Novartis Investigative Site
  • Piracicaba, Brazil, 13419-155
    • Novartis Investigative Site
  • Recife, Brazil, 50040-000
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  • Rio De Janeiro, Brazil, 20560-120
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  • Salvador, Brazil, 41810 570
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  • Sao Paulo, Brazil, 01255-000
    • Novartis Investigative Site
  • PR
    • Londrina, PR, Brazil, 86015-520
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  • RS
    • Ijuí, RS, Brazil, 98700-000
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    • Porto Alegre, RS, Brazil, 90035-903
      • Novartis Investigative Site
    • Porto Alegre, RS, Brazil, 90880-480
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    • Porto Alegre, RS, Brazil, 90560-030
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  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
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    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
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  • SP
    • Santo Andre, SP, Brazil, 09060-650
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    • Sao Paulo, SP, Brazil, 04014-002
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    • Sao Paulo, SP, Brazil, 01317 000
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  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784 400
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• Canada
  • Quebec, Canada, G1S 4L8
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  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
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    • Edmonton, Alberta, Canada, T6G 1Z2
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  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
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    • North Vancouver, British Columbia, Canada, V7L 2L7
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    • Surrey, British Columbia, Canada, V3V 1Z2
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    • Vancouver, British Columbia, Canada, V5Z 4E6
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  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
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  • Ontario
    • Kitchener, Ontario, Canada, N2G 1G3
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    • London, Ontario, Canada, N6A 5W9
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    • Newmarket, Ontario, Canada, J7Y 2P9
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    • Oshawa, Ontario, Canada, L1G 2B9
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    • Sault Ste Marie, Ontario, Canada, P6B 0A8
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    • Sudbury, Ontario, Canada, P3E 5J1
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    • Toronto, Ontario, Canada, M5G 2M9
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    • Toronto, Ontario, Canada, M4N 3M5
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    • Windsor, Ontario, Canada, N8W 2X3
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  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H2W 1T8
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H4A 3J1
      • Novartis Investigative Site
    • Montreal, Quebec, Canada, H3T 1E2
      • Novartis Investigative Site
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Novartis Investigative Site
    • St Jerome, Quebec, Canada, J7Z 5T3
      • Novartis Investigative Site
• China
  • Beijing, China, 100021
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  • Chongqing, China, 400016
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  • Guangzhou, China, 510000
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  • Nanjing, China, 210036
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  • Shanghai, China, 200032
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  • Zhenjiang, China, 310009
    • Novartis Investigative Site
  • Hebei
    • Shijiazhuang, Hebei, China, 050011
      • Novartis Investigative Site
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Novartis Investigative Site
  • Henan
    • Zhengzhou, Henan, China, 450008
      • Novartis Investigative Site
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Novartis Investigative Site
  • Jiangsu
    • Suzhou, Jiangsu, China, 215004
      • Novartis Investigative Site
  • Jilin
    • Chang Chun, Jilin, China, 130021
      • Novartis Investigative Site
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Novartis Investigative Site
  • Tianjin
    • Tianjin, Tianjin, China, 300480
      • Novartis Investigative Site
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Novartis Investigative Site
• France
  • Amiens, France, 80000
    • Novartis Investigative Site
  • Angers Cedex 02, France, 49055
    • Novartis Investigative Site
  • Argenteuil, France, 95107
    • Novartis Investigative Site
  • Avignon, France, 84082
    • Novartis Investigative Site
  • Besancon cedex, France, 25030
    • Novartis Investigative Site
  • Bordeaux Cedex, France, 33076
    • Novartis Investigative Site
  • Bron Cedex, France, 69677
    • Novartis Investigative Site
  • Caen, France, 14021
    • Novartis Investigative Site
  • Grenoble cedex, France, 38028
    • Novartis Investigative Site
  • Le Mans, France, 72000
    • Novartis Investigative Site
  • Marseille, France, 13008
    • Novartis Investigative Site
  • Montpellier, France, 34070
    • Novartis Investigative Site
  • Montpellier Cedex 5, France, 34298
    • Novartis Investigative Site
  • Nantes cedex 2, France, 44202
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  • Paris, France, 75231
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  • Paris, France, 75970
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  • Paris, France, 75015
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  • Paris 10, France, 75475
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  • Paris 13, France, 75651
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  • Pierre Benite, France, 69495
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  • Rouen, France, 76038
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  • Saint Herblain, France, 44805
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  • Strasbourg, France, F 67085
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  • Toulouse, France, 31059
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  • Vandoeuvre-les-Nancy, France, 54519
    • Novartis Investigative Site
  • Villejuif, France, 94800
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  • Alpes Maritimes
    • Nice Cedex 2, Alpes Maritimes, France, 06189
      • Novartis Investigative Site
  • Cote D Or
    • Dijon, Cote D Or, France, 21034
      • Novartis Investigative Site
  • Haute Vienne
    • Limoges, Haute Vienne, France, 87000
      • Novartis Investigative Site
  • Hauts De Seine
    • Saint-Cloud, Hauts De Seine, France, 92210
      • Novartis Investigative Site
  • Ille Et Vilaine
    • Rennes Cedex, Ille Et Vilaine, France, 35062
      • Novartis Investigative Site
  • Rhone
    • Lyon cedex 04, Rhone, France, 69317
      • Novartis Investigative Site
• Germany
  • Augsburg, Germany, 86150
    • Novartis Investigative Site
  • Bad Liebenwerda, Germany, 04924
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  • Berlin, Germany, 13125
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  • Bonn, Germany, 53111
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  • Bottrop, Germany, 46236
    • Novartis Investigative Site
  • Cottbus, Germany, 03048
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  • Dresden, Germany, 01307
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  • Erlangen, Germany, 91054
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  • Essen, Germany, 45147
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  • Frankfurt, Germany, 60431
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  • Hamburg, Germany, 20357
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  • Kiel, Germany, 24105
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  • Mainz, Germany, 55131
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  • Mannheim, Germany, 68167
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  • Moenchengladbach, Germany, 41061
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  • Muenchen, Germany, 81377
    • Novartis Investigative Site
  • Muenster, Germany, 48149
    • Novartis Investigative Site
  • Munchen, Germany, 81675
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  • Regensburg, Germany, 93053
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  • Schweinfurt, Germany, 97422
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  • Tuebingen, Germany, 72076
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  • Ulm, Germany, 89081
    • Novartis Investigative Site
  • Wuerzburg, Germany, 97080
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  • Baden-Wuerttemberg
    • Ravensburg, Baden-Wuerttemberg, Germany, 88212
      • Novartis Investigative Site
  • Bavaria
    • Muenchen, Bavaria, Germany, 80637
      • Novartis Investigative Site
  • Lower Saxony
    • Georgsmarienhuette, Lower Saxony, Germany, 49124
      • Novartis Investigative Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30177
      • Novartis Investigative Site
  • Nordrhein-Westfalen
    • Essen, Nordrhein-Westfalen, Germany, 45136
      • Novartis Investigative Site
  • North Rhine-Westphalia
    • Velbert, North Rhine-Westphalia, Germany, 42551
      • Novartis Investigative Site
• Hungary
  • Budapest, Hungary, 1145
    • Novartis Investigative Site
  • Budapest, Hungary, 1085
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  • Budapest, Hungary, H-1032
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  • Debrecen, Hungary, 4032
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  • Kecskemet, Hungary, 6000
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  • Pecs, Hungary, 7623
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  • Szeged, Hungary, 6725
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  • Szekszard, Hungary, 7100
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  • Szombathely, Hungary, 9700
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  • Tatabanya, Hungary, H 2800
    • Novartis Investigative Site
  • Zala
    • Zalaegerszeg, Zala, Hungary, 8900
      • Novartis Investigative Site
• Ireland
  • County Limerick, Ireland, V94 F858
    • Novartis Investigative Site
  • Dublin, Ireland, 8
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  • Dublin 4, Ireland, D04
    • Novartis Investigative Site
  • Dublin 7, Ireland, 533615
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  • Waterford, Ireland
    • Novartis Investigative Site
  • Cork
    • Wilton, Cork, Ireland, 95683
      • Novartis Investigative Site
  • D9
    • Dublin 9, D9, Ireland, D09
      • Novartis Investigative Site
• Italy
  • Napoli, Italy, 80131
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  • AN
    • Torrette AN, AN, Italy, 60126
      • Novartis Investigative Site
  • BG
    • Bergamo, BG, Italy, 24127
      • Novartis Investigative Site
  • BO
    • Bologna, BO, Italy, 40138
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  • CT
    • Catania, CT, Italy, 95123
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  • MI
    • Milano, MI, Italy, 20133
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    • Rozzano, MI, Italy, 20089
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  • PA
    • Palermo, PA, Italy, 90146
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  • PN
    • Aviano, PN, Italy, 33081
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  • RM
    • Roma, RM, Italy, 00128
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  • TO
    • Candiolo, TO, Italy, 10060
      • Novartis Investigative Site
• Korea, Republic of
  • Incheon, Korea, Republic of, 405 760
    • Novartis Investigative Site
  • Incheon, Korea, Republic of, 22332
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  • Seongnam Si Gyeonggi Do, Korea, Republic of, 463-712
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  • Seoul, Korea, Republic of, 03080
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  • Seoul, Korea, Republic of, 06351
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  • Seoul, Korea, Republic of, 02841
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  • Seoul, Korea, Republic of, 158-710
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  • Seoul, Korea, Republic of, 05505
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  • Ulsan, Korea, Republic of, 44033
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  • Chungcheongbuk Do
    • Cheongju si, Chungcheongbuk Do, Korea, Republic of, 28644
      • Novartis Investigative Site
  • Daegu
    • Seoul, Daegu, Korea, Republic of, 41404
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  • Gangwon-do
    • Wonju-si, Gangwon-do, Korea, Republic of, 26426
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  • Gyeonggi Do
    • Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
      • Novartis Investigative Site
  • Korea
    • Gyeonggi do, Korea, Korea, Republic of, 10408
      • Novartis Investigative Site
    • Seoul, Korea, Korea, Republic of, 03722
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  • Kyonggi Do
    • Suwon, Kyonggi Do, Korea, Republic of, 16499
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  • Seocho Gu
    • Seoul, Seocho Gu, Korea, Republic of, 06591
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• Poland
  • Bialystok, Poland, 15 027
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  • Gdynia, Poland, 81 519
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  • Gliwice, Poland, 44 101
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  • Grudziadz, Poland, 86 300
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  • Krakow, Poland, 31 501
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  • Lodz, Poland, 90-338
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  • Lublin, Poland, 20 090
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  • Opole, Poland, 45 054
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  • Ostroleka, Poland, 07 410
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  • Otwock, Poland, 05 400
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  • Wieliszew, Poland, 05 135
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  • Wroclaw, Poland, 53 413
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  • Ul Roentgena 5
    • Warsaw, Ul Roentgena 5, Poland, 02 781
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• Romania
  • Bucuresti, Romania, 011171
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  • Cluj-Napoca, Romania, 400124
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  • Timisoara, Romania, 300425
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  • Dolj
    • Craiova, Dolj, Romania, 200347
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    • Craiova, Dolj, Romania, 200535
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• Russian Federation
  • Chelyabinsk, Russian Federation, 454087
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  • Kazan, Russian Federation, 420029
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  • Kostroma, Russian Federation, 156005
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  • Krasnoyarsk, Russian Federation, 660022
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  • Moscow, Russian Federation, 115478
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  • Moscow, Russian Federation, 143423
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  • Moscow, Russian Federation, 111123
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  • Nizhny Novgorod, Russian Federation, 603137
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  • Novosibirsk, Russian Federation, 630000
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  • Obninsk, Russian Federation, 249036
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  • Omsk, Russian Federation, 644013
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  • Orenburg, Russian Federation, 460021
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  • Rostov-na-Donu, Russian Federation, 344037
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  • Ryazan, Russian Federation, 390011
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  • St Petersburg, Russian Federation, 197758
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  • St- Petersburg, Russian Federation, 197022
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  • Tyumen, Russian Federation, 625041
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  • Ufa, Russian Federation, 450054
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  • Yaroslavl, Russian Federation, 150054
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  • Russia
    • Leningrad Region, Russia, Russian Federation, 188663
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  • Saint Petersburg
    • St Petersburg, Saint Petersburg, Russian Federation, 195271
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• Spain
  • Castellon, Spain, 12002
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  • Girona, Spain, 17007
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  • Granada, Spain, 18016
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  • Las Palmas de Gran Canaria, Spain, 35010
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  • Madrid, Spain, 28034
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  • Madrid, Spain, 28033
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  • Madrid, Spain, 28040
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  • Madrid, Spain, 28009
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  • Madrid, Spain, 28222
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  • Murcia, Spain, 30008
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  • Valencia, Spain, 46009
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  • Zaragoza, Spain, 50009
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  • Alicante
    • Elche, Alicante, Spain, 03203
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  • Andalucia
    • Cordoba, Andalucia, Spain, 14004
      • Novartis Investigative Site
    • Granada, Andalucia, Spain, 18014
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    • Huelva, Andalucia, Spain, 21005
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    • Jaen, Andalucia, Spain, 23007
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    • Madrid, Andalucia, Spain, 28046
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    • Malaga, Andalucia, Spain, 29010
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    • Sevilla, Andalucia, Spain, 41013
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  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
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  • Castilla Y Leon
    • Burgos, Castilla Y Leon, Spain, 09006
      • Novartis Investigative Site
    • Salamanca, Castilla Y Leon, Spain, 37007
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  • Catalunya
    • Badalona, Catalunya, Spain, 08916
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    • Barcelona, Catalunya, Spain, 08035
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    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
    • Manresa, Catalunya, Spain, 08240
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  • Cataluña
    • Barcelona, Cataluña, Spain, 08907
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  • Comunidad Valenciana
    • Alicante, Comunidad Valenciana, Spain, 03550
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46014
      • Novartis Investigative Site
    • Valencia, Comunidad Valenciana, Spain, 46010
      • Novartis Investigative Site
  • Extremadura
    • Badajoz, Extremadura, Spain, 06080
      • Novartis Investigative Site
    • Caceres, Extremadura, Spain, 10003
      • Novartis Investigative Site
  • Galicia
    • A Coruna, Galicia, Spain, 15009
      • Novartis Investigative Site
    • La Coruna, Galicia, Spain, 15006
      • Novartis Investigative Site
    • Lugo, Galicia, Spain, 27003
      • Novartis Investigative Site
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Novartis Investigative Site
  • Murcia
    • El Palmar, Murcia, Spain, 30120
      • Novartis Investigative Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Novartis Investigative Site
  • Pais Vasco
    • Bilbao, Pais Vasco, Spain, 48013
      • Novartis Investigative Site
    • San Sebastian, Pais Vasco, Spain, 20080
      • Novartis Investigative Site
    • Vitoria Gasteiz, Pais Vasco, Spain, 01009
      • Novartis Investigative Site
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Novartis Investigative Site
  • Santa Cruz De Tenerife
    • La Laguna, Santa Cruz De Tenerife, Spain, 38320
      • Novartis Investigative Site
• Taiwan
  • Changhua, Taiwan, 50006
    • Novartis Investigative Site
  • Taichung, Taiwan, 40447
    • Novartis Investigative Site
  • Taichung, Taiwan, 407
    • Novartis Investigative Site
  • Tainan, Taiwan, 70403
    • 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
• United Kingdom
  • Cardiff, United Kingdom, CF14 2TL
    • Novartis Investigative Site
  • London, United Kingdom, SE1 9RT
    • Novartis Investigative Site
  • London, United Kingdom, SW3 6JJ
    • Novartis Investigative Site
  • London, United Kingdom, NW1 2BU
    • Novartis Investigative Site
  • London, United Kingdom, SM2 5PT
    • Novartis Investigative Site
  • Nottingham, United Kingdom, NG5 1PB
    • Novartis Investigative Site
  • Oxford, United Kingdom, OX3 7LJ
    • Novartis Investigative Site
  • Preston, United Kingdom, PR2 9HT
    • Novartis Investigative Site
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Novartis Investigative Site
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
      • Novartis Investigative Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0006
      • University of Alabama at Birmingham/ Kirklin Clinic .
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Cancer Treatment Centers of America .
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • ST Bernards Medical Center
  • California
    • Bakersfield, California, United States, 93309
      • Comprehensive Blood and Cancer SC-2
    • Beverly Hills, California, United States, 90212
      • UCLA Beverly Hills
    • Burbank, California, United States, 91505
      • UCLA Burbank
    • Encino, California, United States, 91436
      • Encino Research Center .
    • Fullerton, California, United States, 92835
      • St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr
    • Laguna Hills, California, United States, 92653
      • UCLA Hematology Oncology .
    • Los Angeles, California, United States, 91405
      • Valley Breast Care and Women s Health Center
    • Los Angeles, California, United States, 90057
      • Southern California Oncology Research Alliance SCORA .
    • Palo Alto, California, United States, 94304-1509
      • Stanford University Medical Center .
    • Pasadena, California, United States, 941105
      • UCLA Pasadena Health Care Hematology Oncology .
    • Porter Ranch, California, United States, 91326
      • UCLA Porter Ranch Hematology and Oncology .
    • Redondo Beach, California, United States, 90277
      • Cancer Care Associates Medical Group
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital Regulatory
    • San Francisco, California, United States, 94115
      • University of California San Francisco .
    • Santa Maria, California, United States, 93454
      • Central Coast Medical Oncology Corporation Onc Dept
    • Santa Monica, California, United States, 90404
      • UCLA Santa Monica Hematology / Oncology Regulatory-2
    • Torrance, California, United States, 90509-2910
      • Lundquist Inst BioMed at Harbor .
    • Valencia, California, United States, 91355
      • UCLA Valencia
    • Westlake Village, California, United States, 91361
      • UCLA Cancer Center, Westlake Village .
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital .
    • Longmont, Colorado, United States, 80501
      • Rocky Mountain Cancer Centers .
  • Connecticut
    • New Britain, Connecticut, United States, 06052
      • Hospital of Central Connecticut .
    • New Haven, Connecticut, United States, 06520
      • Yale University School Of Medicine .
    • Norwalk, Connecticut, United States, 06856
      • Norwalk Hospital Pulmonary Medicine
    • Norwich, Connecticut, United States, 06360
      • Eastern Connecticut Hematology and Oncology Associates Regulatory
  • Florida
    • Fort Lauderdale, Florida, United States, 33308
      • Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01
    • Fort Myers, Florida, United States, 33901
      • Florida Cancer Specialists .
    • Hollywood, Florida, United States, 33021
      • Memorial Cancer Institute .
    • Jacksonville, Florida, United States, 32207
      • Baptist MD Anderson Cancer Center
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32806
      • Orlando Health Clinical Trials Orlando Health Inc
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists-North .
    • Tallahassee, Florida, United States, 32308
      • Florida Cancer Specialists Pan
    • West Palm Beach, Florida, United States, 33401
      • Florida Cancer Specialists- East Region .
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute of Emory University .
    • Newnan, Georgia, United States, 30265
      • Southeastern Regional Medical Center
  • Illinois
    • Zion, Illinois, United States, 60099
      • Cancer Treatment Centers of America .
  • Indiana
    • New Albany, Indiana, United States, 47150
      • Cancer Care Center .
  • Kansas
    • Westwood, Kansas, United States, 66205
      • University of Kansas Cancer Center
    • Wichita, Kansas, United States, 67214-3728
      • Cancer Center of Kansas
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute .
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center .
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Cancer Center .
  • Minnesota
    • Maple Grove, Minnesota, United States, 55369
      • Fairview Health Services
    • Saint Louis Park, Minnesota, United States, 55416
      • Metro Minnesota CCOP Metro Minneapolis CCOP
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Institute .
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Kansas City, Missouri, United States, 64132
      • HCA Midwest Division .
    • Saint Louis, Missouri, United States, 63141
      • David C Pratt Cancer Center
  • Montana
    • Billings, Montana, United States, 59102
      • St Vincent Frontier Cancer Center .
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Saint Francis Medical Center .
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Comprehensive Cancer Centers of Nevada .
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Saint Barnabas Medical Center .
  • New York
    • New York, New York, United States, 10016
      • Perlmutter Cancer Centre
  • North Carolina
    • Asheboro, North Carolina, United States, 27204
      • Randolph Medical Associates .
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center .
  • Oregon
    • Clackamas, Oregon, United States, 97015
      • Kaiser Permanente NW Region .
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Cancer Institute .
    • Philadelphia, Pennsylvania, United States, 19124
      • Cancer Treatment Centers of America Eastern Regional Medical Center
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • The West Clinic .
    • Nashville, Tennessee, United States, 37203
      • Sarah Cannon Research Institute .
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor Charles A. Sammons Cancer Center .
    • Fort Worth, Texas, United States, 76104
      • Center for Cancer and Blood Disorders Research Department
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center/University of Texas .
  • Utah
    • Salt Lake City, Utah, United States, 84106
      • Utah Cancer Specialists .
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists .
    • Richmond, Virginia, United States, 23230
      • Virginia Cancer Institute .
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutchinson Cancer Center Medical Oncology
  • Wisconsin
    • Madison, Wisconsin, United States, 53792-6164
      • University of Wisconsin / Paul P. Carbone Comp Cancer Center .

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient is ≥ 18 years-old at the time of PICF signature
• Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.
• Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
• Patient has breast cancer that is positive for ER and/or PgR
• Patient has HER2-negative breast cancer
• Patient has available archival tumor tissue from the surgical specimen
• 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 II or III
• If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
• If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines
• Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
• Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years

Exclusion Criteria:

• Patient has received any CDK4/6 inhibitor
• 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.
• 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.
• Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
• 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.
• Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
• Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization
• Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
• Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization
• Patient has known HIV infection, Hepatitis B or C infection
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
• Patient is currently receiving any of the following substances within 7 days before randomization - Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
• is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment
• Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
• 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
• 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.
• Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ribociclib + Endocrine Therapy; Participants will receive ribociclib 400 mg once daily on days 1-21 of a 28-day cycle and endocrine therapy once daily continuously	Drug: Ribociclib; Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle; Other: Endocrine Therapy; ET will be administered according to the local clinical guidelines and current local prescribing information
Active Comparator: Endocrine Therapy; Participants will receive endocrine therapy only once daily continuously	Other: Endocrine Therapy; ET will be administered according to the local clinical guidelines and current local prescribing information

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease-Free Survival (iDFS)	iDFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator. iDFS is defined as 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).	Up to approximately 91 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence-free survival (RFS)	RFS using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials). 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).	Up to approximately 91 months
Distant disease-free survival (DDFS)	DDFS using STEEP criteria. 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).	Up to approximately 91 months
Overall Survival (OS)	OS is defined as the time from date of randomization to date of death due to any cause.	Up to approximately 91 months
Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30	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 91 months
Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30	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 91 months
PK parameters: Ctrough and other applicable parameters for ribociclib	Pharmacokinetics of ribociclib: Ctrough and other applicable parameters	Cycle 1 Day 15

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Collaborators: Translational Research in Oncology
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Estimated): May 29, 2026
• Study Completion (Estimated): May 29, 2026

Study Registration Dates

• First Submitted: September 21, 2018
• First Submitted That Met QC Criteria: October 7, 2018
• First Posted (Actual): October 10, 2018

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: adjuvant; LEE011; ribociclib; CDK4/6 inhibitor; early breast cancer (EBC); HR+/HER2-
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011O12301C; 2018-002998-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No