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

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)

ClinicalTrials.gov Identifier: NCT03701334

Novartis Reference Number: CLEE011O12301C

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Early Breast Cancer
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
5000 participants
Start date 
Dec 07, 2018
Completion date 
May 29, 2026
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Drug
Ribociclib
Ribociclib + ET
Other
Endocrine Therapy
Endocrine Therapy (ET)

Eligibility Criteria

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 Locations

United States
University of Alabama at Birmingham/ Kirklin Clinic
Recruiting
Birmingham, 35294-0006
Alabama
United States
Cancer Treatment Centers of America
Recruiting
Goodyear, 85338
Arizona
United States
St Bernards Medical Center
Recruiting
Jonesboro, 72401
Arkansas
United States
Comprehensive Blood and Cancer Center SC-2
Recruiting
Bakersfield, 93309
California
United States
UCLA Beverly Hills
Recruiting
Beverly Hills, 90212
California
United States
UCLA Burbank
Recruiting
Burbank, 91505
California
United States
Encino Research Center
Recruiting
Encino, 91436
California
United States
UCLA Hematology Oncology
Recruiting
Laguna Hills, 92653
California
United States
Southern California Oncology Research Alliance SCORA
Recruiting
Los Angeles, 90057
California
United States
UCLA Central Regulatory
Recruiting
Los Angeles, 90095
California
United States
Valley Breast Care and Women s Health Center
Recruiting
Los Angeles, 91405
California
United States
Stanford University Medical Center
Recruiting
Palo Alto, 94304-1509
California
United States
UCLA Pasadena Health Care Hematology Oncology
Recruiting
Pasadena, 941105
California
United States
UCLA Porter Ranch Hematology and Oncology
Recruiting
Porter Ranch, 91326
California
United States
Cancer Care Associates Medical Group
Recruiting
Redondo Beach, 90277
California
United States
Sharp Memorial Hospital Regulatory
Recruiting
San Diego, 92123
California
United States
University of California San Francisco Gynecologic Oncology
Recruiting
San Francisco, 94115
California
United States
Central Coast Medical Oncology Corporation Onc Dept
Recruiting
Santa Maria, 93454
California
United States
UCLA Santa Monica Hematology / Oncology Regulatory-2
Recruiting
Santa Monica, 90404
California
United States
Lundquist Inst BioMed at Harbor
Recruiting
Torrance, 90509-2910
California
United States
Gene Upshaw Memorial Tahoe Forest Cancer Cntr
Withdrawn
Truckee, 96161
California
United States
UCLA Valencia
Recruiting
Valencia, 91355
California
United States
Wellness Oncology Hematology TRM
Withdrawn
West Hills, 91307
California
United States
UCLA Cancer Center, Westlake Village
Recruiting
Westlake Village, 91361
California
United States
St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr
Recruiting
Yorba Linda, 92886
California
United States
University of Colorado Hospital
Recruiting
Aurora, 80045
Colorado
United States
Rocky Mountain Cancer Centers
Recruiting
Greenwood Village, 80303
Colorado
United States
Hospital of Central Connecticut
Recruiting
New Britain, 06052
Connecticut
United States
Yale University School of Medicine
Recruiting
New Haven, 06520
Connecticut
United States
Norwalk Hospital Pulmonary Medicine
Recruiting
Norwalk, 06856
Connecticut
United States
Eastern Connecticut Hematology and Oncology Associates Regulatory
Recruiting
Norwich, 06360
Connecticut
United States
Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01
Recruiting
Fort Lauderdale, 33308
Florida
United States
Florida Cancer Specialists
Recruiting
Fort Myers, 33901
Florida
United States
Memorial Cancer Institute
Recruiting
Hollywood, 33021
Florida
United States
Baptist MD Anderson Cancer Center
Recruiting
Jacksonville, 32207
Florida
United States
University of Miami
Recruiting
Miami, 33136
Florida
United States
Orlando Health, Clinical Trials Orlando Health Inc
Recruiting
Orlando, 32806
Florida
United States
Florida Cancer Specialists - North
Recruiting
Saint Petersburg, 33705
Florida
United States
Florida Cancer Specialists Panhandle
Recruiting
Tallahassee, 32308
Florida
United States
Florida Cancer Specialists- East Region
Recruiting
West Palm Beach, 33401
Florida
United States
Winship Cancer Institute of Emory University
Recruiting
Atlanta, 30322
Georgia
United States
Southeastern Regional Medical Center
Recruiting
Newnan, 30265
Georgia
United States
Cancer Treatment Centers of America
Recruiting
Zion, 60099
Illinois
United States
Fort Wayne Medical Oncology/Hematology, Inc.
Withdrawn
Fort Wayne, 46815
Indiana
United States
Cancer Care Center
Recruiting
New Albany, 47150
Indiana
United States
University of Kansas Cancer Center
Recruiting
Westwood, 66205
Kansas
United States
Cancer Center of Kansas
Recruiting
Wichita, 67214-3728
Kansas
United States
Mercy Medical Center
Recruiting
Baltimore, 21202
Maryland
United States
Massachusetts General Hospital
Recruiting
Boston, 02114
Massachusetts
United States
University of Michigan Cancer Center
Recruiting
Ann Arbor, 48109
Michigan
United States
Fairview Health Services
Recruiting
Maple Grove, 55369
Minnesota
United States
Metro Minnesota CCOP Metro Minneapolis CCOP
Recruiting
Saint Louis Park, 55416
Minnesota
United States
Park Nicollet Institute
Recruiting
Saint Louis Park, 55416
Minnesota
United States
Saint Luke's Hospital of Kansas City
Recruiting
Kansas City, 64111
Missouri
United States
HCA Midwest Division
Recruiting
Kansas City, 64132
Missouri
United States
David C Pratt Cancer Center
Recruiting
Saint Louis, 63141
Missouri
United States
St Vincent Frontier Cancer Center
Recruiting
Billings, 59102
Montana
United States
Saint Francis Medical Center
Recruiting
Grand Island, 68803
Nebraska
United States
Comprehensive Cancer Centers of Nevada
Recruiting
Las Vegas, 89109
Nevada
United States
Saint Barnabas Medical Center
Recruiting
Livingston, 07039
New Jersey
United States
Perlmutter Cancer Centre
Recruiting
New York, 10016
New York
United States
Randolph Medical Associates
Recruiting
Asheboro, 27204
North Carolina
United States
Alamance Regional Medical Cancer Center
Recruiting
Burlington, 27215
North Carolina
United States
Cone Health Cancer Center
Recruiting
Greensboro, 27403
North Carolina
United States
Kaiser Permanente NW Region
Recruiting
Clackamas, 97015
Oregon
United States
Penn State Hershey Cancer Institute
Recruiting
Hershey, 17033
Pennsylvania
United States
Cancer Treatment Centers of America Eastern Regional Medical Center
Recruiting
Philadelphia, 19124
Pennsylvania
United States
Tidelands Health Oncology
Recruiting
Murrells Inlet, 29576
South Carolina
United States
The West Clinic
Recruiting
Germantown, 38138
Tennessee
United States
Sarah Cannon Research Institute
Recruiting
Nashville, 37203
Tennessee
United States
Baylor Charles A. Sammons Cancer Center
Recruiting
Dallas, 75246
Texas
United States
Center for Cancer and Blood Disorders Research Department
Recruiting
Fort Worth, 76104
Texas
United States
MD Anderson Cancer Center/University of Texas
Recruiting
Houston, 77030
Texas
United States
USO Central Regulatory
Recruiting
The Woodlands, 77380
Texas
United States
Utah Cancer Specialists
Recruiting
Salt Lake City, 84106
Utah
United States
Virginia Cancer Specialists
Recruiting
Fairfax, 22031
Virginia
United States
Virginia Cancer Institute
Recruiting
Richmond, 23230
Virginia
United States
Seattle Cancer Care Alliance Medical Oncology
Recruiting
Seattle, 98109
Washington
United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center
Recruiting
Madison, 53792-6164
Wisconsin
United States
Argentina
Novartis Investigative Site
Recruiting
Rosario, S2000
Santa Fe
Argentina
Novartis Investigative Site
Recruiting
Rosario, S200KZE
Sante Fe
Argentina
Novartis Investigative Site
Recruiting
San Miguel De Tucuman, T4000IAK
Tucuman
Argentina
Novartis Investigative Site
Recruiting
Rio Negro, 8500
Viedma
Argentina
Novartis Investigative Site
Recruiting
Caba, C1419AHN
-
Argentina
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Recruiting
Cordoba, X5004FHP
-
Argentina
Novartis Investigative Site
Recruiting
Jujuy, 4600
-
Argentina
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La Rioja, 5300
-
Argentina
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Santa Fe, 3000
-
Argentina
Australia
Novartis Investigative Site
Recruiting
Campbelltown, 2560
New South Wales
Australia
Novartis Investigative Site
Recruiting
Coffs Harbour, 2450
New South Wales
Australia
Novartis Investigative Site
Recruiting
Darlinghurst, 2010
New South Wales
Australia
Novartis Investigative Site
Recruiting
Kingswood, 2747
New South Wales
Australia
Novartis Investigative Site
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Kogarah, 2217
New South Wales
Australia
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Liverpool, 2170
New South Wales
Australia
Novartis Investigative Site
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North Ryde, 2109
New South Wales
Australia
Novartis Investigative Site
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St Leonards, 2065
New South Wales
Australia
Novartis Investigative Site
Recruiting
Wahroonga, 2076
New South Wales
Australia
Novartis Investigative Site
Recruiting
Westmead, 2145
New South Wales
Australia
Novartis Investigative Site
Recruiting
Auchenflower, 4066
Queensland
Australia
Novartis Investigative Site
Recruiting
Birtinya, 4575
Queensland
Australia
Novartis Investigative Site
Recruiting
Wooloongabba, 4102
Queensland
Australia
Novartis Investigative Site
Recruiting
Bedford Park, 5042
South Australia
Australia
Novartis Investigative Site
Recruiting
Bendigo, 3550
Victoria
Australia
Novartis Investigative Site
Recruiting
East Melbourne, 3002
Victoria
Australia
Novartis Investigative Site
Recruiting
Epping, 3076
Victoria
Australia
Novartis Investigative Site
Recruiting
Fitzroy, 3065
Victoria
Australia
Novartis Investigative Site
Recruiting
Franston, 3199
Victoria
Australia
Novartis Investigative Site
Recruiting
Heidelberg, 3084
Victoria
Australia
Novartis Investigative Site
Recruiting
Melbourne, 3000
Victoria
Australia
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Recruiting
Shepparton, 3630
Victoria
Australia
Novartis Investigative Site
Recruiting
Murdoch, 6150
Western Australia
Australia
Novartis Investigative Site
Recruiting
Nedlands, 6009
Western Australia
Australia
Austria
Novartis Investigative Site
Recruiting
Graz, 8036
Styria
Austria
Novartis Investigative Site
Recruiting
Innsbruck, 6020
Tyrol
Austria
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Recruiting
Linz, 4020
-
Austria
Novartis Investigative Site
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Salzburg, 5020
-
Austria
Novartis Investigative Site
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Wien, 1090
-
Austria
Belgium
Novartis Investigative Site
Recruiting
Edegem, 2650
Antwerpen
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1000
-
Belgium
Novartis Investigative Site
Recruiting
Bruxelles, 1090
-
Belgium
Novartis Investigative Site
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Bruxelles, 1200
-
Belgium
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Recruiting
Charleroi, 6000
-
Belgium
Novartis Investigative Site
Recruiting
Hasselt, 3500
-
Belgium
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Recruiting
Leuven, 3000
-
Belgium
Novartis Investigative Site
Recruiting
Libramont, 6800
-
Belgium
Novartis Investigative Site
Recruiting
Liege, 4000
-
Belgium
Novartis Investigative Site
Recruiting
Namur, 5000
-
Belgium
Novartis Investigative Site
Recruiting
Wilrijk, 2610
-
Belgium
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Recruiting
Yvoir, 5530
-
Belgium
Brazil
Novartis Investigative Site
Recruiting
Londrina, 86015-520
PR
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90050-170
Rio Grande Do Sul
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90610-000
Rio Grande Do Sul
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90035-903
RS
Brazil
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Recruiting
Porto Alegre, 90560-030
RS
Brazil
Novartis Investigative Site
Recruiting
Porto Alegre, 90880-480
RS
Brazil
Novartis Investigative Site
Recruiting
Barretos, 14784 400
Sao Paulo
Brazil
Novartis Investigative Site
Recruiting
Santo Andre, 09060-650
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 01317 000
SP
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 03102-002
SP
Brazil
Novartis Investigative Site
Recruiting
Caxias do Sul, 95070-560
-
Brazil
Novartis Investigative Site
Recruiting
Ijui, 98700-000
-
Brazil
Novartis Investigative Site
Recruiting
Passo Fundo, 99010-080
-
Brazil
Novartis Investigative Site
Recruiting
Piracicaba, 13419-155
-
Brazil
Novartis Investigative Site
Recruiting
Recife, 50040-000
-
Brazil
Novartis Investigative Site
Recruiting
Rio De Janeiro, 20560-120
-
Brazil
Novartis Investigative Site
Recruiting
Salvador, 41810 570
-
Brazil
Novartis Investigative Site
Recruiting
Sao Paulo, 01255-000
-
Brazil
Canada
Novartis Investigative Site
Recruiting
Calgary, T2N 4N2
Alberta
Canada
Novartis Investigative Site
Recruiting
Edmonton, T6G 1Z2
Alberta
Canada
Novartis Investigative Site
Recruiting
Kelowna, V1Y 5L3
British Columbia
Canada
Novartis Investigative Site
Recruiting
North Vancouver, V7L 2L7
British Columbia
Canada
Novartis Investigative Site
Recruiting
Surrey, V3V 1Z2
British Columbia
Canada
Novartis Investigative Site
Recruiting
Vancouver, V5Z 4E6
British Columbia
Canada
Novartis Investigative Site
Recruiting
Halifax, B3H 1V7
Nova Scotia
Canada
Novartis Investigative Site
Recruiting
Kitchener, N2G 1G3
Ontario
Canada
Novartis Investigative Site
Recruiting
London, N6A 4L6
Ontario
Canada
Novartis Investigative Site
Recruiting
Newmarket, J7Y 2P9
Ontario
Canada
Novartis Investigative Site
Recruiting
Oshawa, L1G 2B9
Ontario
Canada
Novartis Investigative Site
Recruiting
Sault Ste Marie, P6B 0A8
Ontario
Canada
Novartis Investigative Site
Recruiting
Sudbury, P3E 5J1
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M4N 3M5
Ontario
Canada
Novartis Investigative Site
Recruiting
Toronto, M5G 2M9
Ontario
Canada
Novartis Investigative Site
Recruiting
Windsor, N8W 2X3
Ontario
Canada
Novartis Investigative Site
Recruiting
Greenfield Park, J4V 2H1
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H1T 2M4
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H2W 1T8
Quebec
Canada
Novartis Investigative Site
Recruiting
Montreal, H3T 1E2
Quebec
Canada
Novartis Investigative Site
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Montreal, H4A 3J1
Quebec
Canada
Novartis Investigative Site
Recruiting
Sherbrooke, J1H 5N4
Quebec
Canada
Novartis Investigative Site
Recruiting
St-Jerome, J7Z 5T3
Quebec
Canada
Novartis Investigative Site
Recruiting
Quebec, G1S 4L8
-
Canada
China
Novartis Investigative Site
Recruiting
Chang Chun, 130021
Jilin
China
Novartis Investigative Site
Recruiting
Hangzhou, 310016
Zhejiang
China
France
Novartis Investigative Site
Recruiting
Nice Cedex 2, 06189
Alpes Maritimes
France
Novartis Investigative Site
Recruiting
Dijon Cedex, 21034
Cote D Or
France
Novartis Investigative Site
Recruiting
Limoges cedex, 87000
Haute Vienne
France
Novartis Investigative Site
Recruiting
Saint-Cloud, 92210
Hauts De Seine
France
Novartis Investigative Site
Recruiting
Rennes Cedex, 35062
Ille Et Vilaine
France
Novartis Investigative Site
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Amiens, 80000
-
France
Novartis Investigative Site
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Angers Cedex 02, 49055
-
France
Novartis Investigative Site
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Argenteuil, 95107
-
France
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Avignon Cedex, 84082
-
France
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Besancon cedex, 25030
-
France
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Bobigny Cedex, 93009
-
France
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Bordeaux Cedex, 33076
-
France
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Caen Cedex, 14021
-
France
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Grenoble cedex, 38028
-
France
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Le Mans, 72000
-
France
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Lyon, 69317
-
France
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Lyon, 69677
-
France
Novartis Investigative Site
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Marseille, 13008
-
France
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Montpellier Cedex 5, 34298
-
France
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Montpellier, 34070
-
France
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Nantes cedex 2, 44202
-
France
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Paris Cedex 13, 75651
-
France
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Paris, 75010
-
France
Novartis Investigative Site
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Paris, 75015
-
France
Novartis Investigative Site
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Paris, 75231
-
France
Novartis Investigative Site
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Paris, 75970
-
France
Novartis Investigative Site
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Pierre Benite Cedex, 69495
-
France
Novartis Investigative Site
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Rouen Cedex 1, 76038
-
France
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Saint Herblain cedex, 44805
-
France
Novartis Investigative Site
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Strasbourg, F 67085
-
France
Novartis Investigative Site
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Toulouse Cedex 9, 31059
-
France
Novartis Investigative Site
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Vandoeuvre-les-Nancy cedex, 54519
-
France
Novartis Investigative Site
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Villejuif Cedex, 94800
-
France
Germany
Novartis Investigative Site
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Ravensburg, 88212
Baden-Wuerttemberg
Germany
Novartis Investigative Site
Recruiting
Muenchen, 80637
Bavaria
Germany
Novartis Investigative Site
Recruiting
Georgsmarienhuette, 49124
Lower Saxony
Germany
Novartis Investigative Site
Recruiting
Hannover, 30177
Niedersachsen
Germany
Novartis Investigative Site
Recruiting
Duesseldorf, 40325
Nordrhein Westfalen
Germany
Novartis Investigative Site
Recruiting
Essen, 45136
Nordrhein-Westfalen
Germany
Novartis Investigative Site
Recruiting
Velbert, 42551
North Rhine-westphalia
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86150
-
Germany
Novartis Investigative Site
Recruiting
Augsburg, 86179
-
Germany
Novartis Investigative Site
Recruiting
Bad Liebenwerda, 04924
-
Germany
Novartis Investigative Site
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Berlin, 13125
-
Germany
Novartis Investigative Site
Recruiting
Bonn, 53111
-
Germany
Novartis Investigative Site
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Bottrop, 46236
-
Germany
Novartis Investigative Site
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Cottbus, 03048
-
Germany
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Dresden, 01307
-
Germany
Novartis Investigative Site
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Erlangen, 91054
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Germany
Novartis Investigative Site
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Essen, 45147
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Germany
Novartis Investigative Site
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Esslingen, 73730
-
Germany
Novartis Investigative Site
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Frankfurt, 60431
-
Germany
Novartis Investigative Site
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Halle S, 06120
-
Germany
Novartis Investigative Site
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Hamburg, 20246
-
Germany
Novartis Investigative Site
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Hamburg, 20357
-
Germany
Novartis Investigative Site
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Kiel, 24105
-
Germany
Novartis Investigative Site
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Lüneburg, 21339
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Germany
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Mainz, 55131
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Germany
Novartis Investigative Site
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Mannheim, 68167
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Germany
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Moenchengladbach, 41061
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Germany
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Muenchen, 81377
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Germany
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Muenster, 48149
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Germany
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Munchen, 81675
-
Germany
Novartis Investigative Site
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Regensburg, 93053
-
Germany
Novartis Investigative Site
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Rostock, 18059
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Germany
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