Clinical trial NCT00248170: Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Official title: Comparison Trial of Letrozole to Anastrozole in the Adjuvant Treatment of Postmenopausal Women With Hormone Receptor and Node Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
letrozole
anastrozole
adjuvant
postmenopausal
FACE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-03
Enrollment: 4172
Sex: FEMALE
Minimum age (years): 33
Maximum age (years): 96
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Disease Free Survival
timeFrame: 84 months
Secondary outcomes:
measure: Overall Survival
timeFrame: 84 months
measure: Time to Development of Distant Metastases
timeFrame: 84 months
measure: Time to Development of Contra Lateral Breast Cancer
timeFrame: 84 months
measure: Distant Disease-free Survival
timeFrame: 84 months
measure: Change From Baseline in Serum Lipid Profiles
timeFrame: baseline, 6, 12, 24, 36, 48 and 60 months
measure: Percentage of Participants Who Experienced Clinical Fracture Events
timeFrame: 84 months
measure: Percentage of Participants Who Experienced Cardiovascular Events
timeFrame: 84 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates
state: Alabama
city: Huntsville
country: United States
facility: Comprehensive Cancer Institute
state: Alabama
city: Flagstaff
country: United States
facility: Northern Arizona Hematology/Oncology Associates, P.C.
state: Arizona
city: New London
country: United States
facility: Oncology & Hematology Associates, PC
state: Connecticut
city: Fort Meyers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Jacksonville
country: United States
facility: Sarah Cannon Research Institute
state: Florida
city: Ocoee
country: United States
facility: Cancer Centers of Florida PA
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Institute
state: Florida
city: St. Petersburg
country: United States
facility: Gulfcoast Oncology Associates
state: Florida
city: Athens
country: United States
facility: University Cancer & Blood Center, LLC
state: Georgia
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Center
state: Kansas
city: Wichita
country: United States
facility: Wichita Community Clinical Oncology Program
state: Kansas
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders
state: Maryland
city: St. Louis
country: United States
facility: St. Louis Cancer & Breast Institute
state: Missouri
city: Troy
country: United States
facility: New York Oncology Hematology, P.C. NYOH Latham
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Canton
country: United States
facility: Aultman Cancer Center
state: Ohio
city: Cincinnati
country: United States
facility: Sarah Cannon Oncology Hematology Care, Inc
state: Ohio
city: Eugene
country: United States
facility: Oncology Associates of Oregon, PC
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates of Wyorning Valley, PC
state: Pennsylvania
city: Chattanooga
country: United States
facility: Chattanooga Oncology and Hematology Assoicates, PC
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment, PA
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center ( Medical City Dallas Hospital)
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology Texas Oncology PA
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center Denton
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr-East
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fredericksburg
country: United States
facility: San Antonio Tumor and Blood Clinic
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center/University of Texas
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: McAllen
country: United States
facility: South Texas Cancer Center- McAllen
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center- Sherman
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Waco Cancer and Research Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists, PC
state: Virginia
city: Vancover
country: United States
facility: Northwest Cancer Specialists, P.C.
state: Washington
city: Garran
country: Australia
facility: Novartis Investigative Site
state: Australian Capital Territory
city: Port Macquarie
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Randwick
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Sydney
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Tweed Heads
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Waratah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Nambour
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Redcliff
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Toorak Gardens
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: East Bentleigh
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Epping
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Footscray
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Franston
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Malvern
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Wodonga
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Auckland
country: Australia
facility: Novartis Investigative Site
city: Dunedin
country: Australia
facility: Novartis Investigative Site
city: Hamilton
country: Australia
facility: Novartis Investigative Site
city: Feldkirch
country: Austria
facility: Novartis Investigative Site
city: Friesach
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Güssing
country: Austria
facility: Novartis Investigative Site
city: Innsbruck
country: Austria
facility: Novartis Investigative Site
city: Leoben
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Linz
country: Austria
facility: Novartis Investigative Site
city: Salzburg
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Villach
country: Austria
facility: Novartis Investigative Site
city: Wels
country: Austria
facility: Novartis Investigative Site
city: Wiener Neustadt
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Wien
country: Austria
facility: Novartis Investigative Site
city: Aalst
country: Belgium
facility: Novartis Investigative Site
city: Antwerpen
country: Belgium
facility: Novartis Investigative Site
city: Bonheiden
country: Belgium
facility: Novartis Investigative Site
city: Brasschaat
country: Belgium
facility: Novartis Investigative Site
city: Brugge
country: Belgium
facility: Novartis Investigative Site
city: Bruxelles
country: Belgium
facility: Novartis Investigative Site
city: Gent
country: Belgium
facility: Novartis Investigative Site
city: Libramont
country: Belgium
facility: Novartis Investigative Site
city: Liege
country: Belgium
facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Turnhout
country: Belgium
facility: Novartis Investigative Site
city: Verviers
country: Belgium
facility: Novartis Investigative Site
city: Wilrijk
country: Belgium
facility: Novartis Investigative Site
city: Newmarket
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Regina
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Tianjin
country: China
facility: Novartis Investigative Site
state: Tianjin
city: Beijing
country: China
facility: Novartis Investigative Site
city: Guangzhou
country: China
facility: Novartis Investigative Site
city: Shanghai
country: China
facility: Novartis Investigative Site
city: Aalborg
country: Denmark
facility: Novartis Investigative Site
city: Copenhagen
country: Denmark
facility: Novartis Investigative Site
city: Herlev
country: Denmark
facility: Novartis Investigative Site
city: Herning
country: Denmark
facility: Novartis Investigative Site
city: Hillerød
country: Denmark
facility: Novartis Investigative Site
city: Næstved
country: Denmark
facility: Novartis Investigative Site
city: Odense C
country: Denmark
facility: Novartis Investigative Site
city: Roskilde
country: Denmark
facility: Novartis Investigative Site
city: Vejle
country: Denmark
facility: Novartis Investigative Site
city: Viborg
country: Denmark
facility: Novartis Investigative Site
city: Angers cedex 9
country: France
facility: Novartis Investigative Site
city: Caen Cedex
country: France
facility: Novartis Investigative Site
city: Creteil
country: France
facility: Novartis Investigative Site
city: Le Chesnay
country: France
facility: Novartis Investigative Site
city: Lyon
country: France
facility: Novartis Investigative Site
city: Marseille
country: France
facility: Novartis Investigative Site
city: Montbeliard
country: France
facility: Novartis Investigative Site
city: Montpellier
country: France
facility: Novartis Investigative Site
city: Nice
country: France
facility: Novartis Investigative Site
city: Perpignan
country: France
facility: Novartis Investigative Site
city: Périgueux Cédex
country: France
facility: Novartis Investigative Site
city: Rennes Cedex
country: France
facility: Novartis Investigative Site
city: Strasbourg
country: France
facility: Novartis Investigative Site
city: Toulouse Cedex
country: France
facility: Novartis Investigative Site
city: Amberg
country: Germany
facility: Novartis Investigative Site
city: Bayreuth
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bremen
country: Germany
facility: Novartis Investigative Site
city: Duesseldorf
country: Germany
facility: Novartis Investigative Site
city: Erlangen
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Freiburg
country: Germany
facility: Novartis Investigative Site
city: Halle/'Saale
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Kiel
country: Germany
facility: Novartis Investigative Site
city: Lübeck
country: Germany
facility: Novartis Investigative Site
city: Lüneburg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Offenbach
country: Germany
facility: Novartis Investigative Site
city: Regensburg
country: Germany
facility: Novartis Investigative Site
city: Trier
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Witten
country: Germany
facility: Novartis Investigative Site
city: Cork
country: Ireland
facility: Novartis Investigative Site
city: Dublin 24
country: Ireland
facility: Novartis Investigative Site
city: Dublin 4
country: Ireland
facility: Novartis Investigative Site
city: Dublin 7
country: Ireland
facility: Novartis Investigative Site
city: Dublin 8
country: Ireland
facility: Novartis Investigative Site
city: Dublin
country: Ireland
facility: Novartis Investigative Site
city: Galway
country: Ireland
facility: Novartis Investigative Site
city: Letterkenny
country: Ireland
facility: Novartis Investigative Site
city: Limerick
country: Ireland
facility: Novartis Investigative Site
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Rehovot
country: Israel
facility: Novartis Investigative Site
city: Tel-Aviv
country: Israel
facility: Novartis Investigative Site
city: Tel-Hashomer
country: Israel
facility: Novartis Investigative Site
city: Montevarchi
country: Italy
facility: Novartis Investigative Site
state: AR
city: Bari
country: Italy
facility: Novartis Investigative Site
state: BA
city: Biella
country: Italy
facility: Novartis Investigative Site
state: BI
city: Bologna
country: Italy
facility: Novartis Investigative Site
state: BO
city: Chieti
country: Italy
facility: Novartis Investigative Site
state: CH
city: Catania
country: Italy
facility: Novartis Investigative Site
state: CT
city: Antella - Bagno a Ripoli
country: Italy
facility: Novartis Investigative Site
state: FI
city: Forli
country: Italy
facility: Novartis Investigative Site
state: FO
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Milano
country: Italy
facility: Novartis Investigative Site
state: MI
city: Modena
country: Italy
facility: Novartis Investigative Site
state: MO
city: Aviano
country: Italy
facility: Novartis Investigative Site
state: PN
city: Parma
country: Italy
facility: Novartis Investigative Site
state: PR
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Castelfranco Veneto
country: Italy
facility: Novartis Investigative Site
state: TV
city: Udine
country: Italy
facility: Novartis Investigative Site
state: UD
city: Verona
country: Italy
facility: Novartis Investigative Site
state: VR
city: Fermo
country: Italy
facility: Novartis Investigative Site
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Matsuyama
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Kitakyushu
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Maebashi-city
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Sapporo
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Isehara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kawasaki-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kyoto-city
country: Japan
facility: Novartis Investigative Site
state: Kyoto
city: Suita-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Shimotsuke-city
country: Japan
facility: Novartis Investigative Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Koto
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Novartis Investigative Site
city: Osaka
country: Japan
facility: Novartis Investigative Site
city: Shizuoka
country: Japan
facility: Novartis Investigative Site
city: Goyang
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
city: Enschede
country: Netherlands
facility: Novartis Investigative Site
city: Nijmegen
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Veldhoven
country: Netherlands
facility: Novartis Investigative Site
city: Skien
country: Norway
facility: Novartis Investigative Site
city: Malaga
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Sabadell
country: Spain
facility: Novartis Investigative Site
state: Barcelona
city: Santander
country: Spain
facility: Novartis Investigative Site
state: Cantabria
city: Valencia
country: Spain
facility: Novartis Investigative Site
state: Comunidad Valenciana
city: A Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: La Coruna
country: Spain
facility: Novartis Investigative Site
state: Galicia
city: Alicante
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zaragoza
country: Spain
facility: Novartis Investigative Site
city: Lund
country: Sweden
facility: Novartis Investigative Site
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Chur
country: Switzerland
facility: Novartis Investigative Site
city: Luzern
country: Switzerland
facility: Novartis Investigative Site
city: Schaffhausen
country: Switzerland
facility: Novartis Investigative Site
city: Winterthur
country: Switzerland
facility: Novartis Investigative Site
city: Hull
country: United Kingdom
facility: Novartis Investigative Site
state: East Yorkshire
city: Northwood
country: United Kingdom
facility: Novartis Investigative Site
state: Middlesex
city: Belfast
country: United Kingdom
facility: Novartis Investigative Site
city: Bournemouth
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Chelmsford
country: United Kingdom
facility: Novartis Investigative Site
city: Colchester
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Manchester
country: United Kingdom
facility: Novartis Investigative Site
city: Merseyside
country: United Kingdom
facility: Novartis Investigative Site
city: Plymouth
country: United Kingdom
facility: Novartis Investigative Site
city: Rhyl
country: United Kingdom
facility: Novartis Investigative Site
city: Sheffiled
country: United Kingdom
facility: Novartis Investigative Site
city: Shrewsbury
country: United Kingdom
facility: Novartis Investigative Site
city: Surrey
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: