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

March 20, 2016 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4172

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

33 years to 96 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
84 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
84 months
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.
84 months
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.
84 months
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.
84 months
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.
baseline, 6, 12, 24, 36, 48 and 60 months
Percentage of Participants Who Experienced Clinical Fracture Events
Time Frame: 84 months
The incidence of clinical fractures was analyzed.
84 months
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.
84 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 2, 2005

First Submitted That Met QC Criteria

November 2, 2005

First Posted (Estimate)

November 3, 2005

Study Record Updates

Last Update Posted (Estimate)

April 19, 2016

Last Update Submitted That Met QC Criteria

March 20, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345D2411
  • 2005-004263-35 (EudraCT Number)
  • EUDRACT number 2005-004263-35 (Registry Identifier: EUDRACT)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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