Freitag, 23. April 2021
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JOURNAL ONKOLOGIE – STUDIE
NATALEE

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

Rekrutierend

NCT-Nummer:
NCT03701334

Studienbeginn:
Dezember 2018

Letztes Update:
26.02.2021

Wirkstoff:
Ribociclib

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Novartis Pharmaceuticals

Collaborator:
Translational Research in Oncology

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations
(3 von 399)

Novartis Investigative Site
88212 Ravensburg
(Baden-Württemberg)
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Novartis Investigative Site
80637 Muenchen
(Bayern)
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Novartis Investigative Site
49124 Georgsmarienhuette
(Niedersachsen)
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Novartis Investigative Site
30177 Hannover
(Niedersachsen)
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Novartis Investigative Site
40325 Duesseldorf
(Nordrhein-Westfalen)
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Novartis Investigative Site
45136 Essen
(Nordrhein-Westfalen)
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Novartis Investigative Site
42551 Velbert
(Nordrhein-Westfalen)
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Novartis Investigative Site
86150 Augsburg
(Bayern)
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Novartis Investigative Site
86179 Augsburg
(Bayern)
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Novartis Investigative Site
04924 Bad Liebenwerda
(Brandenburg)
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Novartis Investigative Site
13125 Berlin
(Berlin)
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Novartis Investigative Site
53111 Bonn
(Nordrhein-Westfalen)
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Novartis Investigative Site
46236 Bottrop
(Nordrhein-Westfalen)
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Novartis Investigative Site
03048 Cottbus
(Brandenburg)
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Novartis Investigative Site
01307 Dresden
(Sachsen)
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Novartis Investigative Site
91054 Erlangen
(Bayern)
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Novartis Investigative Site
45147 Essen
(Nordrhein-Westfalen)
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Novartis Investigative Site
73730 Esslingen
(Baden-Württemberg)
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Novartis Investigative Site
60431 Frankfurt
(Hessen)
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06120 Halle S
(Sachsen-Anhalt)
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20246 Hamburg
(Hamburg)
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20357 Hamburg
(Hamburg)
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24105 Kiel
(Schleswig-Holstein)
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21339 Lüneburg
(Niedersachsen)
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Novartis Investigative Site
55131 Mainz
(Rheinland-Pfalz)
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Novartis Investigative Site
68167 Mannheim
(Baden-Württemberg)
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Novartis Investigative Site
41061 Moenchengladbach
(Nordrhein-Westfalen)
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Novartis Investigative Site
81377 Muenchen
(Bayern)
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Novartis Investigative Site
48149 Muenster
(Nordrhein-Westfalen)
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Novartis Investigative Site
81675 Munchen
(Bayern)
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Novartis Investigative Site
93053 Regensburg
(Bayern)
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Novartis Investigative Site
18059 Rostock
(Mecklenburg-Vorpommern)
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Novartis Investigative Site
97422 Schweinfurt
(Bayern)
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72076 Tübingen
(Baden-Württemberg)
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Novartis Investigative Site
89081 Ulm
(Baden-Württemberg)
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Novartis Investigative Site
97080 Wuerzburg
(Bayern)
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University of Alabama at Birmingham/ Kirklin Clinic
35294-0006 Birmingham
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Cancer Treatment Centers of America
85338 Goodyear
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St Bernards Medical Center
72401 Jonesboro
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UCLA Hematology Oncology
92653 Laguna Hills
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Southern California Oncology Research Alliance SCORA
90057 Los Angeles
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Valley Breast Care and Women s Health Center
91405 Los Angeles
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Stanford University Medical Center
94304-1509 Palo Alto
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UCLA Pasadena Health Care Hematology Oncology
941105 Pasadena
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UCLA Porter Ranch Hematology and Oncology
91326 Porter Ranch
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University of California San Francisco Gynecologic Oncology
94115 San Francisco
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Central Coast Medical Oncology Corporation Onc Dept
93454 Santa Maria
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Lundquist Inst BioMed at Harbor
90509-2910 Torrance
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Gene Upshaw Memorial Tahoe Forest Cancer Cntr
96161 Truckee
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Wellness Oncology Hematology TRM
91307 West Hills
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UCLA Cancer Center, Westlake Village
91361 Westlake Village
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University of Colorado Hospital
80045 Aurora
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Rocky Mountain Cancer Centers
80303 Greenwood Village
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Hospital of Central Connecticut
06052 New Britain
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Yale University School of Medicine
06520 New Haven
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Eastern Connecticut Hematology and Oncology Associates Regulatory
06360 Norwich
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Memorial Cancer Institute
33021 Hollywood
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Orlando Health, Clinical Trials Orlando Health Inc
32806 Orlando
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Florida Cancer Specialists - North
33705 Saint Petersburg
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Florida Cancer Specialists Panhandle
32308 Tallahassee
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Florida Cancer Specialists- East Region
33401 West Palm Beach
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Winship Cancer Institute of Emory University
30322 Atlanta
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Cancer Treatment Centers of America
60099 Zion
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Fort Wayne Medical Oncology/Hematology, Inc.
46815 Fort Wayne
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University of Michigan Cancer Center
48109 Ann Arbor
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Fairview Health Services
55369 Maple Grove
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Park Nicollet Institute
55416 Saint Louis Park
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HCA Midwest Division
64132 Kansas City
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Comprehensive Cancer Centers of Nevada
89109 Las Vegas
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Saint Barnabas Medical Center
07039 Livingston
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Perlmutter Cancer Centre
10016 New York
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Randolph Medical Associates
27204 Asheboro
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Alamance Regional Medical Cancer Center
27215 Burlington
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Kaiser Permanente NW Region
97015 Clackamas
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Tidelands Health Oncology
29576 Murrells Inlet
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Baylor Charles A. Sammons Cancer Center
75246 Dallas
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Center for Cancer and Blood Disorders Research Department
76104 Fort Worth
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USO Central Regulatory
77380 The Woodlands
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Utah Cancer Specialists
84106 Salt Lake City
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Virginia Cancer Specialists
22031 Fairfax
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Virginia Cancer Institute
23230 Richmond
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Seattle Cancer Care Alliance Medical Oncology
98109 Seattle
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Novartis Investigative Site
S2000 Rosario
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S200KZE Rosario
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T4000IAK San Miguel De Tucuman
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8500 Rio Negro
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C1419AHN Caba
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X5004FHP Cordoba
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5300 La Rioja
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3000 Santa Fe
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2560 Campbelltown
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2450 Coffs Harbour
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2010 Darlinghurst
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2747 Kingswood
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2217 Kogarah
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2170 Liverpool
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2109 North Ryde
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2065 St Leonards
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2076 Wahroonga
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2145 Westmead
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4066 Auchenflower
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Novartis Investigative Site
4575 Birtinya
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4102 Wooloongabba
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5042 Bedford Park
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3550 Bendigo
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3002 East Melbourne
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3065 Fitzroy
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3199 Franston
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3084 Heidelberg
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3000 Melbourne
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3630 Shepparton
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6150 Murdoch
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6009 Nedlands
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6020 Innsbruck
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1000 Bruxelles
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1090 Bruxelles
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Novartis Investigative Site
1200 Bruxelles
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6000 Charleroi
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6800 Libramont
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86015-520 Londrina
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90050-170 Porto Alegre
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90610-000 Porto Alegre
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90035-903 Porto Alegre
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90560-030 Porto Alegre
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90880-480 Porto Alegre
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14784 400 Barretos
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09060-650 Santo Andre
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01317 000 Sao Paulo
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03102-002 Sao Paulo
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95070-560 Caxias do Sul
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99010-080 Passo Fundo
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13419-155 Piracicaba
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50040-000 Recife
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20560-120 Rio De Janeiro
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41810 570 Salvador
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01255-000 Sao Paulo
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T2N 4N2 Calgary
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T6G 1Z2 Edmonton
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V1Y 5L3 Kelowna
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V7L 2L7 North Vancouver
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V5Z 4E6 Vancouver
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B3H 1V7 Halifax
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N2G 1G3 Kitchener
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J7Y 2P9 Newmarket
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P6B 0A8 Sault Ste Marie
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P3E 5J1 Sudbury
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M4N 3M5 Toronto
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M5G 2M9 Toronto
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N8W 2X3 Windsor
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J4V 2H1 Greenfield Park
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H1T 2M4 Montreal
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H2W 1T8 Montreal
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H3T 1E2 Montreal
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H4A 3J1 Montreal
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J1H 5N4 Sherbrooke
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J7Z 5T3 St-Jerome
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130021 Chang Chun
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06189 Nice Cedex 2
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21034 Dijon Cedex
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87000 Limoges cedex
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92210 Saint-Cloud
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35062 Rennes Cedex
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49055 Angers Cedex 02
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95107 Argenteuil
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84082 Avignon Cedex
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25030 Besancon cedex
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93009 Bobigny Cedex
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33076 Bordeaux Cedex
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14021 Caen Cedex
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38028 Grenoble cedex
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13008 Marseille
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34298 Montpellier Cedex 5
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34070 Montpellier
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44202 Nantes cedex 2
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75651 Paris Cedex 13
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69495 Pierre Benite Cedex
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76038 Rouen Cedex 1
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44805 Saint Herblain cedex
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F 67085 Strasbourg
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31059 Toulouse Cedex 9
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54519 Vandoeuvre-les-Nancy cedex
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94800 Villejuif Cedex
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8900 Zalaegerszeg
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H-1032 Budapest
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6000 Kecskemet
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7100 Szekszard
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9700 Szombathely
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H 2800 Tatabanya
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V94 F858 County Limerick
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60126 Torrette AN
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28644 Cheongju si
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41404 Seoul
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26426 Wonju-si
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13620 Bundang Gu
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10408 Gyeonggi do
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03722 Seoul
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16499 Suwon
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06591 Seoul
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22332 Incheon
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405 760 Incheon
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463-712 Seongnam Si Gyeonggi Do
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02841 Seoul
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03080 Seoul
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05505 Seoul
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06351 Seoul
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158-710 Seoul
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44033 Ulsan
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15 027 Bialystok
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86 300 Grudziadz
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07 410 Ostroleka
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05 135 Wieliszew
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200347 Craiova
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200535 Craiova
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010991 Bucuresti
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011171 Bucuresti
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400124 Cluj-Napoca
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300239 Timisoara
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188663 Leningrad Region
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195271 St Petersburg
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454087 Chelyabinsk
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420029 Kazan
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156005 Kostroma
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660022 Krasnoyarsk
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305035 Kursk
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111123 Moscow
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115478 Moscow
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143423 Moscow
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603137 Nizhny Novgorod
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249036 Obninsk
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644013 Omsk
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460021 Orenburg
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344037 Rostov-na-Donu
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390011 Ryazan
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197758 St Petersburg
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197022 St- Petersburg
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625041 Tyumen
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450054 Ufa
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150054 Yaroslavl
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28942 Fuenlabrada
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20080 San Sebastian
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01009 Vitoria-Gasteiz
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TR1 3LJ Truro
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M16 9QQ Maidstone
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CF14 2TL Cardiff
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Studien-Informationen

Brief Summary:

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

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Invasive Disease-Free Survival (Time Frame - 44 months):
Invasive Disease-Free Survival for ribociclib + Endocrine Therapy versus Endocrine Therapy in patients with HR-positive, HER2-negative Early Breast Cancer using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator



Secondary outcome:

1. Recurrence-free survival (Time Frame - 44 months):
using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)

2. Distant disease-free survival (Time Frame - 44 months):
using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)

3. Overall Survival (Time Frame - 91 months):
overall survival

4. Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30 (Time Frame - 44 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.

5. Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30 (Time Frame - 44 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.

6. PK parameter Ctrough and other applicable parameters for ribociclib (Time Frame - 44 months):
Pharmacokinetics of ribociclib when given in combination with Non-Steroidal Aromatase Inhibitor (and goserelin if applicable)

Studien-Arme

  • Experimental: Ribociclib + Endocrine Therapy
    ribociclib 400 mg once daily on days 1-21 of a 28 day cycle followed by 7 days off" and endocrine therapy (ET) once daily continuously
  • Active Comparator: Endocrine Therapy
    endocrine therapy (ET) only once daily continuously

Geprüfte Regime

  • Ribociclib:
    Ribociclib + ET
  • Endocrine Therapy:
    Endocrine Therapy (ET)

Quelle: ClinicalTrials.gov


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