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Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer (FACE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248170
First Posted: November 3, 2005
Last Update Posted: April 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
Eligible patients will be post-menopausal hormone receptor- and lymph node-positive females who recently underwent primary surgery for breast cancer. Patients will be randomized to letrozole (2.5 mg per day for 5 years) vs anastrozole (1 mg per day for 5 years). Follow up will occur for 5 years after the completion of enrollment for survival and disease status updates.

Condition Intervention Phase
Breast Cancer Drug: Letrozole Drug: Anastrozole Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: 84 months ]
    Disease-free survival was defined as the time from the date of randomization to the date of the first documentation of re-occurrence of invasive breast cancer in local, regional or distant sites, new invasive breast cancer in the contra-lateral breast, or death from any cause.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 84 months ]
    Overall survival was defined as the time from the date of randomization to the date of death from any cause.

  • Time to Development of Distant Metastases [ Time Frame: 84 months ]
    Time to development of distant metastases was defined as the time from date of randomization to the date of the first development of any recurrent or metastatic disease in sites other than the local mastectomy scar, the ipsilateral breast in case of breast conservation or the contra lateral breast.

  • Time to Development of Contra Lateral Breast Cancer [ Time Frame: 84 months ]
    Time to development of contra lateral breast cancer was defined as the time from the date of randomization to the date of the first development of any disease in the contra lateral breast.

  • Distant Disease-free Survival [ Time Frame: 84 months ]
    Distant disease-free survival was defined as the time from date of randomization to the date of the first development of any relapse at a distant site or death from any cause.

  • Change From Baseline in Serum Lipid Profiles [ Time Frame: baseline, 6, 12, 24, 36, 48 and 60 months ]
    Total cholesterol was analyzed to assess the impact on serum lipids profiles. The adjusted means was calculated.

  • Percentage of Participants Who Experienced Clinical Fracture Events [ Time Frame: 84 months ]
    The incidence of clinical fractures was analyzed.

  • Percentage of Participants Who Experienced Cardiovascular Events [ Time Frame: 84 months ]
    The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.


Enrollment: 4172
Study Start Date: December 2005
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole
2.5 mg by mouth (p.o.) once daily
Drug: Letrozole
2.5 mg tablets
Active Comparator: Anastrozole
1 mg p.o. once daily
Drug: Anastrozole
1 mg tablets

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   33 Years to 96 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recent primary surgery for breast cancer
  • Early stage breast cancer
  • Postmenopausal
  • Hormone receptor positive
  • Positive lymph node involvement

Exclusion Criteria:

  • Metastatic disease
  • Presence of contralateral breast cancer including DCIS
  • Progression

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00248170


  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States, 35205
Comprehensive Cancer Institute
Huntsville, Alabama, United States, 35801
United States, Arizona
Northern Arizona Hematology/Oncology Associates, P.C.
Flagstaff, Arizona, United States, 86001
United States, Connecticut
Oncology & Hematology Associates, PC
New London, Connecticut, United States, 06320
United States, Florida
Florida Cancer Specialists
Fort Meyers, Florida, United States, 33901
Sarah Cannon Research Institute
Jacksonville, Florida, United States, 32256
Cancer Centers of Florida PA
Ocoee, Florida, United States, 34761
Florida Cancer Institute
Orlando, Florida, United States, 32804
Gulfcoast Oncology Associates
St. Petersburg, Florida, United States, 33705
United States, Georgia
University Cancer & Blood Center, LLC
Athens, Georgia, United States, 30607
United States, Indiana
Central Indiana Cancer Centers
Indianapolis, Indiana, United States, 46227
United States, Kansas
Kansas City Cancer Center
Overland Park, Kansas, United States, 66210
Wichita Community Clinical Oncology Program
Wichita, Kansas, United States, 67214
United States, Maryland
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Missouri
St. Louis Cancer & Breast Institute
St. Louis, Missouri, United States, 63141
United States, New York
New York Oncology Hematology, P.C. NYOH Latham
Troy, New York, United States, 12180
United States, North Carolina
Raleigh Hematology Oncology Associates
Cary, North Carolina, United States, 27511
United States, Ohio
Aultman Cancer Center
Canton, Ohio, United States, 44710
Sarah Cannon Oncology Hematology Care, Inc
Cincinnati, Ohio, United States, 45242
United States, Oregon
Oncology Associates of Oregon, PC
Eugene, Oregon, United States, 97401-8122
United States, Pennsylvania
Medical Oncology Associates of Wyorning Valley, PC
Kingston, Pennsylvania, United States, 18704
United States, Tennessee
Chattanooga Oncology and Hematology Assoicates, PC
Chattanooga, Tennessee, United States, 37404
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States, 75230
Texas Cancer Center ( Medical City Dallas Hospital)
Dallas, Texas, United States, 75230
Texas Oncology Presbyterian Hospital
Dallas, Texas, United States, 75246
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology Texas Oncology PA
Dallas, Texas, United States, 75251
Texas Cancer Center Denton
Denton, Texas, United States, 76210
El Paso Cancer Treatment Ctr-East
El Paso, Texas, United States, 79915
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
San Antonio Tumor and Blood Clinic
Fredericksburg, Texas, United States, 78624
MD Anderson Cancer Center/University of Texas
Houston, Texas, United States, 77030
Longview Cancer Center
Longview, Texas, United States, 75601
South Texas Cancer Center- McAllen
McAllen, Texas, United States, 78503
Allison Cancer Center
Midland, Texas, United States, 79701-5946
Texas Cancer Center- Sherman
Sherman, Texas, United States, 75090-0504
Tyler Cancer Center
Tyler, Texas, United States, 75702
Waco Cancer and Research Center
Waco, Texas, United States, 76712
United States, Virginia
Virginia Cancer Specialists, PC
Fairfax, Virginia, United States, 22031
United States, Washington
Northwest Cancer Specialists, P.C.
Vancover, Washington, United States, 98664
Australia, Australian Capital Territory
Novartis Investigative Site
Garran, Australian Capital Territory, Australia, 2605
Australia, New South Wales
Novartis Investigative Site
Port Macquarie, New South Wales, Australia, 2444
Novartis Investigative Site
Randwick, New South Wales, Australia, 2031
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Sydney, New South Wales, Australia, 2060
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Tweed Heads, New South Wales, Australia, 2485
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Waratah, New South Wales, Australia, 2298
Australia, Queensland
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Nambour, Queensland, Australia, 4560
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Redcliff, Queensland, Australia, 4020
Australia, South Australia
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Adelaide, South Australia, Australia, 5000
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Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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East Bentleigh, Victoria, Australia, 3165
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Epping, Victoria, Australia, 3076
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Footscray, Victoria, Australia, 3011
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Franston, Victoria, Australia, 3199
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Malvern, Victoria, Australia, 3144
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Parkville, Victoria, Australia, 3050
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Wodonga, Victoria, Australia, 3690
Australia, Western Australia
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Nedlands, Western Australia, Australia, 6009
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Perth, Western Australia, Australia, 6000
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Perth, Western Australia, Australia, 6005
Australia
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Auckland, Australia
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Dunedin, Australia
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Hamilton, Australia, 3240
Austria
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Feldkirch, Austria, A-6807
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Friesach, Austria, 9360
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Graz, Austria, 8036
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Graz, Austria, A-8036
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Güssing, Austria, 7540
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Innsbruck, Austria, 6020
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Leoben, Austria, A-8700
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Linz, Austria, 4010
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Linz, Austria, A-4020
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Salzburg, Austria, 5020
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Vienna, Austria, 1090
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Villach, Austria, 9500
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Wels, Austria, A-4600
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Wiener Neustadt, Austria, 2700
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Wien, Austria, A-1090
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Wien, Austria, A-1140
Belgium
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Aalst, Belgium, 9300
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Antwerpen, Belgium, 2020
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Bonheiden, Belgium, 2820
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Brasschaat, Belgium, 2930
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Brugge, Belgium, 8000
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Bruxelles, Belgium, 1070
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Gent, Belgium, 9000
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Libramont, Belgium, 6800
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Liege, Belgium, 4000
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Liège, Belgium, 4000
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Turnhout, Belgium, 2300
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Verviers, Belgium, 4800
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Wilrijk, Belgium, 2610
Canada, Ontario
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Newmarket, Ontario, Canada, L3Y 2P7
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4C 3E7
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Montreal, Quebec, Canada, H1T 2M4
Canada, Saskatchewan
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Regina, Saskatchewan, Canada, S4T 7T1
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Saskatoon, Saskatchewan, Canada, S7N 4H4
Canada
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Quebec, Canada, G1S 4L8
China, Tianjin
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Tianjin, Tianjin, China, 300060
China
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Beijing, China, 100021
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Guangzhou, China, 510060
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Shanghai, China, 200032
Denmark
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Aalborg, Denmark, DK-9000
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Copenhagen, Denmark, DK-2100
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Herlev, Denmark, DK-2730
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Herning, Denmark, DK-7400
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Hillerød, Denmark, DK-3400
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Næstved, Denmark, DK-4700
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Odense C, Denmark, DK-5000
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Roskilde, Denmark, DK-4000
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Vejle, Denmark, DK-7100
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Viborg, Denmark, DK-8800
France
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Angers cedex 9, France, 49033
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Caen Cedex, France, 14021
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Creteil, France, 94010
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Le Chesnay, France, 78157
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Lyon, France, F-69373
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Marseille, France, 13008
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Montbeliard, France, 25209
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Montpellier, France, F-34094
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Nice, France, 06050
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Perpignan, France, 66000
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Périgueux Cédex, France, 24004
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Rennes Cedex, France, 35062
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Strasbourg, France, 67091
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Toulouse Cedex, France, 31078
Germany
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Amberg, Germany, 92224
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Bayreuth, Germany, 95445
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Berlin, Germany, 10317
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Berlin, Germany, 10365
Novartis Investigative Site
Berlin, Germany, 10713
Novartis Investigative Site
Berlin, Germany, 10967
Novartis Investigative Site
Berlin, Germany, 13125
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Bremen, Germany, 28205
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Duesseldorf, Germany, 40225
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Erlangen, Germany, 91054
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Essen, Germany, 45147
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Frankfurt, Germany, 65929
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Freiburg, Germany, 79106
Novartis Investigative Site
Freiburg, Germany, 79110
Novartis Investigative Site
Halle/'Saale, Germany, 06120
Novartis Investigative Site
Hannover, Germany, 30559
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Homburg, Germany, 66421
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Jena, Germany, 07740
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Kiel, Germany, 24105
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Lübeck, Germany, 23538
Novartis Investigative Site
Lüneburg, Germany, 21339
Novartis Investigative Site
Magdeburg, Germany, 39108
Novartis Investigative Site
Muenchen, Germany, 80336
Novartis Investigative Site
Muenster, Germany, 48149
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München, Germany, 81675
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Offenbach, Germany, 63069
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Regensburg, Germany, 93053
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Trier, Germany, 54290
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Tuebingen, Germany, 72076
Novartis Investigative Site
Ulm, Germany, 89070
Novartis Investigative Site
Wiesbaden, Germany, 65189
Novartis Investigative Site
Wiesbaden, Germany, D-65199
Novartis Investigative Site
Witten, Germany, 58452
Ireland
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Cork, Ireland
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Dublin 24, Ireland
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Dublin 4, Ireland
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Dublin 7, Ireland
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Dublin 8, Ireland
Novartis Investigative Site
Dublin, Ireland, DUBLIN 9
Novartis Investigative Site
Galway, Ireland
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Letterkenny, Ireland
Novartis Investigative Site
Limerick, Ireland
Israel
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Jerusalem, Israel, 9112001
Novartis Investigative Site
Rehovot, Israel, 76100
Novartis Investigative Site
Tel-Aviv, Israel, 6423906
Novartis Investigative Site
Tel-Hashomer, Israel, 52621
Italy
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Montevarchi, AR, Italy, 52025
Novartis Investigative Site
Bari, BA, Italy, 70126
Novartis Investigative Site
Biella, BI, Italy, 13051
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Bologna, BO, Italy, 40138
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Chieti, CH, Italy, 66100
Novartis Investigative Site
Catania, CT, Italy, 95124
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Antella - Bagno a Ripoli, FI, Italy, 50011
Novartis Investigative Site
Forli, FO, Italy, 47100
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Milano, MI, Italy, 20121
Novartis Investigative Site
Milano, MI, Italy, 20132
Novartis Investigative Site
Modena, MO, Italy, 41100
Novartis Investigative Site
Aviano, PN, Italy, 33081
Novartis Investigative Site
Parma, PR, Italy, 43100
Novartis Investigative Site
Roma, RM, Italy, 00135
Novartis Investigative Site
Roma, RM, Italy, 00167
Novartis Investigative Site
Roma, RM, Italy, 00168
Novartis Investigative Site
Castelfranco Veneto, TV, Italy, 31033
Novartis Investigative Site
Udine, UD, Italy, 33100
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Verona, VR, Italy, 37126
Novartis Investigative Site
Fermo, Italy, 63122
Japan
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Nagoya, Aichi, Japan, 464-8681
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Matsuyama, Ehime, Japan, 791-0280
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan, 802-0077
Novartis Investigative Site
Maebashi-city, Gunma, Japan, 371-8511
Novartis Investigative Site
Sapporo, Hokkaido, Japan, 003-0804
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Isehara-city, Kanagawa, Japan, 259-1193
Novartis Investigative Site
Kawasaki-city, Kanagawa, Japan, 216-8511
Novartis Investigative Site
Yokohama, Kanagawa, Japan, 241-8515
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Kyoto-city, Kyoto, Japan, 606-8507
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Suita-city, Osaka, Japan, 565-0871
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Kitaadachi-gun, Saitama, Japan, 362-0806
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Shimotsuke-city, Tochigi, Japan, 329-0498
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Bunkyo-ku, Tokyo, Japan, 113-8677
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Chuo-ku, Tokyo, Japan, 104-0045
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Chuo-ku, Tokyo, Japan, 104-8560
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Koto, Tokyo, Japan, 135-8550
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Shinjuku-ku, Tokyo, Japan, 160-0023
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Fukuoka, Japan, 811-1395
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Osaka, Japan, 537-8511
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Shizuoka, Japan, 420-8527
Korea, Republic of
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Goyang, Gyeonggi-do, Korea, Republic of, 410-769
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Seoul, Korea, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 01812
Netherlands
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Eindhoven, Netherlands, 5623 EJ
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Enschede, Netherlands, 7511 JH
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Nijmegen, Netherlands, 6532 SZ
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Rotterdam, Netherlands, 3083 AN
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Veldhoven, Netherlands, 5504 DB
Norway
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Skien, Norway, NO-3710
Spain
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Malaga, Andalucia, Spain, 29010
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Sabadell, Barcelona, Spain, 08208
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Santander, Cantabria, Spain, 39008
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Valencia, Comunidad Valenciana, Spain, 46009
Novartis Investigative Site
A Coruna, Galicia, Spain, 15009
Novartis Investigative Site
La Coruna, Galicia, Spain, 15006
Novartis Investigative Site
Alicante, Spain, 03010
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Madrid, Spain, 28040
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Zaragoza, Spain, 50009
Sweden
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Lund, Sweden, 221 85
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Stockholm, Sweden, SE-118 83
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Uppsala, Sweden, SE-751 85
Switzerland
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Chur, Switzerland, 7000
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Luzern, Switzerland, 6000
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Schaffhausen, Switzerland, 8208
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Winterthur, Switzerland, 8401
United Kingdom
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Hull, East Yorkshire, United Kingdom, HU8 9HE
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Northwood, Middlesex, United Kingdom, HA6 2RN
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Belfast, United Kingdom, BT9 7AB
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Bournemouth, United Kingdom, BH7 7DW
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Bristol, United Kingdom, BS16 1JE
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Chelmsford, United Kingdom, CM1 7ET
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Colchester, United Kingdom, CO3 3NB
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Glasgow, United Kingdom, G11 6NT
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Liverpool, United Kingdom, L7 8XP
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London, United Kingdom, N18 1QX
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London, United Kingdom, NW3 2QG
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Manchester, United Kingdom, M23 9LT
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Merseyside, United Kingdom, L63 4JY
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Plymouth, United Kingdom, PL6 8DH
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Rhyl, United Kingdom, LL18 5UJ
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Sheffiled, United Kingdom, S10 2SJ
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Shrewsbury, United Kingdom, SY38XQ
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Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00248170     History of Changes
Other Study ID Numbers: CFEM345D2411
2005-004263-35 ( EudraCT Number )
EUDRACT number 2005-004263-35 ( Registry Identifier: EUDRACT )
First Submitted: November 2, 2005
First Posted: November 3, 2005
Results First Submitted: September 8, 2015
Results First Posted: October 9, 2015
Last Update Posted: April 19, 2016
Last Verified: March 2016

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Breast cancer
letrozole
anastrozole
adjuvant
postmenopausal
FACE

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Letrozole
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal