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

Breast Cancer Clinical Trial

— FACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00248170
• Other study ID #: CFEM345D2411
• Secondary ID: 2005-004263-35EU
• Status: Completed
• Phase: Phase 3
• First received: November 2, 2005
• Last updated: October 14, 2015
• Start date: December 2005
• Est. completion date: September 2014

Study information

• Verified date: October 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustria: The Austrian Agency for Health and Food Safety (AGES)Belgium: Federal Agency for Medicines and Health Products, FAMHPCanada: Health Canada (Therapeutic Products Directorate - TPD)China: State Food and Drug Administration (SFDA)Denmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: Agence francaise de securite sanitaire des produits de santeGermany: Federal Institute for Drugs and Medical DevicesIreland: Irish Medicines BoardIsrael: Ministry of HealthItaly: Agenzia Italiana del FarmacoJapan: Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA)South Korea: Korea Food and Drug Administration (KFDA)Netherlands: Medicines Evaluation Board (MEB)New Zealand: Medsafe - Medicines and Medical Defices Safety AuthoritySpain: Agencia Española de Medicamentos y Productos SanitariosSweden: Medical Products Agency (MPA)Switzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4172
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 33 Years to 96 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole
2.5 mg tablets
• Anastrozole
1 mg tablets

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Auckland
Australia	Novartis Investigative Site	Box Hill	Victoria
Australia	Novartis Investigative Site	Dunedin
Australia	Novartis Investigative Site	East Bentleigh	Victoria
Australia	Novartis Investigative Site	Epping	Victoria
Australia	Novartis Investigative Site	Footscray	Victoria
Australia	Novartis Investigative Site	Franston	Victoria
Australia	Novartis Investigative Site	Garran	Australian Capital Territory
Australia	Novartis Investigative Site	Hamilton
Australia	Novartis Investigative Site	Malvern	Victoria
Australia	Novartis Investigative Site	Nambour	Queensland
Australia	Novartis Investigative Site	Nedlands	Western Australia
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	Perth	Western Australia
Australia	Novartis Investigative Site	Perth	Western Australia
Australia	Novartis Investigative Site	Port Macquarie	New South Wales
Australia	Novartis Investigative Site	Randwick	New South Wales
Australia	Novartis Investigative Site	Redcliff	Queensland
Australia	Novartis Investigative Site	Sydney	New South Wales
Australia	Novartis Investigative Site	Toorak Gardens	South Australia
Australia	Novartis Investigative Site	Tweed Heads	New South Wales
Australia	Novartis Investigative Site	Waratah	New South Wales
Australia	Novartis Investigative Site	Wodonga	Victoria
Austria	Novartis Investigative Site	Feldkirch
Austria	Novartis Investigative Site	Friesach
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Graz
Austria	Novartis Investigative Site	Güssing
Austria	Novartis Investigative Site	Innsbruck
Austria	Novartis Investigative Site	Leoben
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Salzburg
Austria	Novartis Investigative Site	Vienna
Austria	Novartis Investigative Site	Villach
Austria	Novartis Investigative Site	Wels
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wien
Austria	Novartis Investigative Site	Wiener Neustadt
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Antwerpen
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Brasschaat
Belgium	Novartis Investigative Site	Brugge
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Libramont
Belgium	Novartis Investigative Site	Liege
Belgium	Novartis Investigative Site	Liège
Belgium	Novartis Investigative Site	Turnhout
Belgium	Novartis Investigative Site	Verviers
Belgium	Novartis Investigative Site	Wilrijk
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Newmarket	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Quebec
Canada	Novartis Investigative Site	Regina	Saskatchewan
Canada	Novartis Investigative Site	Saskatoon	Saskatchewan
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Tianjin	Tianjin
Denmark	Novartis Investigative Site	Aalborg
Denmark	Novartis Investigative Site	Copenhagen
Denmark	Novartis Investigative Site	Herlev
Denmark	Novartis Investigative Site	Herning
Denmark	Novartis Investigative Site	Hillerød
Denmark	Novartis Investigative Site	Næstved
Denmark	Novartis Investigative Site	Odense C
Denmark	Novartis Investigative Site	Roskilde
Denmark	Novartis Investigative Site	Vejle
Denmark	Novartis Investigative Site	Viborg
France	Novartis Investigative Site	Angers cedex 9
France	Novartis Investigative Site	Caen Cedex
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Le Chesnay
France	Novartis Investigative Site	Lyon
France	Novartis Investigative Site	Marseille
France	Novartis Investigative Site	Montbeliard
France	Novartis Investigative Site	Montpellier
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Périgueux Cédex
France	Novartis Investigative Site	Perpignan
France	Novartis Investigative Site	Rennes Cedex
France	Novartis Investigative Site	Strasbourg
France	Novartis Investigative Site	Toulouse Cedex
Germany	Novartis Investigative Site	Amberg
Germany	Novartis Investigative Site	Bayreuth
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bremen
Germany	Novartis Investigative Site	Duesseldorf
Germany	Novartis Investigative Site	Erlangen
Germany	Novartis Investigative Site	Essen
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Halle/'Saale
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Homburg
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Lübeck
Germany	Novartis Investigative Site	Lüneburg
Germany	Novartis Investigative Site	Magdeburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Offenbach
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Trier
Germany	Novartis Investigative Site	Tuebingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Witten
Ireland	Novartis Investigative Site	Cork
Ireland	Novartis Investigative Site	Dublin
Ireland	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
Israel	Novartis Investigative Site	Jerusalem
Israel	Novartis Investigative Site	Rehovot
Israel	Novartis Investigative Site	Tel-Aviv
Israel	Novartis Investigative Site	Tel-Hashomer
Italy	Novartis Investigative Site	Antella - Bagno a Ripoli	FI
Italy	Novartis Investigative Site	Aviano	PN
Italy	Novartis Investigative Site	Bari	BA
Italy	Novartis Investigative Site	Biella	BI
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Castelfranco Veneto	TV
Italy	Novartis Investigative Site	Catania	CT
Italy	Novartis Investigative Site	Chieti	CH
Italy	Novartis Investigative Site	Fermo
Italy	Novartis Investigative Site	Forli	FO
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Modena	MO
Italy	Novartis Investigative Site	Montevarchi	AR
Italy	Novartis Investigative Site	Parma	PR
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Udine	UD
Italy	Novartis Investigative Site	Verona	VR
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Chuo-ku	Tokyo
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Isehara-city	Kanagawa
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kitaadachi-gun	Saitama
Japan	Novartis Investigative Site	Kitakyushu	Fukuoka
Japan	Novartis Investigative Site	Koto	Tokyo
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Maebashi-city	Gunma
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Nagoya	Aichi
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Shimotsuke-city	Tochigi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shizuoka
Japan	Novartis Investigative Site	Suita-city	Osaka
Japan	Novartis Investigative Site	Yokohama	Kanagawa
Korea, Republic of	Novartis Investigative Site	Goyang	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Netherlands	Novartis Investigative Site	Eindhoven
Netherlands	Novartis Investigative Site	Enschede
Netherlands	Novartis Investigative Site	Nijmegen
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Veldhoven
Norway	Novartis Investigative Site	Skien
Spain	Novartis Investigative Site	A Coruna	Galicia
Spain	Novartis Investigative Site	Alicante
Spain	Novartis Investigative Site	La Coruna	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Sabadell	Barcelona
Spain	Novartis Investigative Site	Santander	Cantabria
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Zaragoza
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Stockholm
Sweden	Novartis Investigative Site	Uppsala
Switzerland	Novartis Investigative Site	Chur
Switzerland	Novartis Investigative Site	Luzern
Switzerland	Novartis Investigative Site	Schaffhausen
Switzerland	Novartis Investigative Site	Winterthur
United Kingdom	Novartis Investigative Site	Belfast
United Kingdom	Novartis Investigative Site	Bournemouth
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Chelmsford
United Kingdom	Novartis Investigative Site	Colchester
United Kingdom	Novartis Investigative Site	Glasgow
United Kingdom	Novartis Investigative Site	Hull	East Yorkshire
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Merseyside
United Kingdom	Novartis Investigative Site	Northwood	Middlesex
United Kingdom	Novartis Investigative Site	Plymouth
United Kingdom	Novartis Investigative Site	Rhyl
United Kingdom	Novartis Investigative Site	Sheffiled
United Kingdom	Novartis Investigative Site	Shrewsbury
United Kingdom	Novartis Investigative Site	Surrey
United States	University Cancer & Blood Center, LLC	Athens	Georgia
United States	Texas Oncology, P.A.	Bedford	Texas
United States	Center for Cancer & Blood Disorders	Bethesda	Maryland
United States	Birmingham Hematology and Oncology Associates	Birmingham	Alabama
United States	Aultman Cancer Center	Canton	Ohio
United States	Raleigh Hematology Oncology Associates	Cary	North Carolina
United States	Chattanooga Oncology and Hematology Assoicates, PC	Chattanooga	Tennessee
United States	Sarah Cannon Oncology Hematology Care, Inc	Cincinnati	Ohio
United States	Center for Oncology Research and Treatment, PA	Dallas	Texas
United States	Texas Cancer Center ( Medical City Dallas Hospital)	Dallas	Texas
United States	Texas Oncology Presbyterian Hospital	Dallas	Texas
United States	Texas Oncology Sammons Cancer Center	Dallas	Texas
United States	Texas Oncology Texas Oncology PA	Dallas	Texas
United States	Texas Cancer Center Denton	Denton	Texas
United States	El Paso Cancer Treatment Ctr-East	El Paso	Texas
United States	Oncology Associates of Oregon, PC	Eugene	Oregon
United States	Virginia Cancer Specialists, PC	Fairfax	Virginia
United States	Northern Arizona Hematology/Oncology Associates, P.C.	Flagstaff	Arizona
United States	Florida Cancer Specialists	Fort Meyers	Florida
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	San Antonio Tumor and Blood Clinic	Fredericksburg	Texas
United States	MD Anderson Cancer Center/University of Texas	Houston	Texas
United States	Comprehensive Cancer Institute	Huntsville	Alabama
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Sarah Cannon Research Institute	Jacksonville	Florida
United States	Medical Oncology Associates of Wyorning Valley, PC	Kingston	Pennsylvania
United States	Longview Cancer Center	Longview	Texas
United States	South Texas Cancer Center- McAllen	McAllen	Texas
United States	Allison Cancer Center	Midland	Texas
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Oncology & Hematology Associates, PC	New London	Connecticut
United States	Cancer Centers of Florida PA	Ocoee	Florida
United States	Florida Cancer Institute	Orlando	Florida
United States	Kansas City Cancer Center	Overland Park	Kansas
United States	Texas Cancer Center- Sherman	Sherman	Texas
United States	St. Louis Cancer & Breast Institute	St. Louis	Missouri
United States	Gulfcoast Oncology Associates	St. Petersburg	Florida
United States	New York Oncology Hematology, P.C. NYOH Latham	Troy	New York
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists, P.C.	Vancover	Washington
United States	Waco Cancer and Research Center	Waco	Texas
United States	Wichita Community Clinical Oncology Program	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  China,  Denmark,  France,  Germany,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival	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	No
Secondary	Overall Survival	Overall survival was defined as the time from the date of randomization to the date of death from any cause.	84 months	No
Secondary	Time to Development of Distant Metastases	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	No
Secondary	Time to Development of Contra Lateral Breast Cancer	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	No
Secondary	Distant Disease-free Survival	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	No
Secondary	Change From Baseline in Serum Lipid Profiles	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	Yes
Secondary	Percentage of Participants Who Experienced Clinical Fracture Events	The incidence of clinical fractures was analyzed.	84 months	Yes
Secondary	Percentage of Participants Who Experienced Cardiovascular Events	The incidence of ischemic heart disease, cardiac failures, cerebrovascular accidents and thromboembolic events was analyzed.	84 months	Yes