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

NCT00248170 | Completed Phase 3 Results

• 3 other identifiers: CFEM345D24112005-004263-35EUDRACT number 2005-004263-35
• Study Type: interventional
• Target: 4,172
• Locations: 19 countries
• Sites: 235

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.

Conditions

Breast Cancer

Keywords

Breast cancer; letrozole; anastrozole; adjuvant; postmenopausal; FACE

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Overall Survival

  84 months

• Time to Development of Distant Metastases

  84 months

• Time to Development of Contra Lateral Breast Cancer

  84 months

• Distant Disease-free Survival

  84 months

• Change From Baseline in Serum Lipid Profiles

  baseline, 6, 12, 24, 36, 48 and 60 months

Study Arms (2)

Letrozole

EXPERIMENTAL

2.5 mg by mouth (p.o.) once daily

Drug: Letrozole

Anastrozole

ACTIVE COMPARATOR

1 mg p.o. once daily

Drug: Anastrozole

Interventions

Letrozole DRUG

2.5 mg tablets

Letrozole

Anastrozole DRUG

1 mg tablets

Anastrozole

Eligibility Criteria

• Age: 33 Years - 96 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (259)

Birmingham Hematology and Oncology Associates

Birmingham, Alabama, 35205, United States

Location

Comprehensive Cancer Institute

Huntsville, Alabama, 35801, United States

Location

Northern Arizona Hematology/Oncology Associates, P.C.

Flagstaff, Arizona, 86001, United States

Location

Oncology & Hematology Associates, PC

New London, Connecticut, 06320, United States

Location

Florida Cancer Specialists

Fort Meyers, Florida, 33901, United States

Location

Sarah Cannon Research Institute

Jacksonville, Florida, 32256, United States

Location

Cancer Centers of Florida PA

Ocoee, Florida, 34761, United States

Location

Florida Cancer Institute

Orlando, Florida, 32804, United States

Location

Gulfcoast Oncology Associates

St. Petersburg, Florida, 33705, United States

Location

University Cancer & Blood Center, LLC

Athens, Georgia, 30607, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46227, United States

Location

Kansas City Cancer Center

Overland Park, Kansas, 66210, United States

Location

Wichita Community Clinical Oncology Program

Wichita, Kansas, 67214, United States

Location

Center for Cancer & Blood Disorders

Bethesda, Maryland, 20817, United States

Location

St. Louis Cancer & Breast Institute

St Louis, Missouri, 63141, United States

Location

New York Oncology Hematology, P.C. NYOH Latham

Troy, New York, 12180, United States

Location

Raleigh Hematology Oncology Associates

Cary, North Carolina, 27511, United States

Location

Aultman Cancer Center

Canton, Ohio, 44710, United States

Location

Sarah Cannon Oncology Hematology Care, Inc

Cincinnati, Ohio, 45242, United States

Location

Oncology Associates of Oregon, PC

Eugene, Oregon, 97401-8122, United States

Location

Medical Oncology Associates of Wyorning Valley, PC

Kingston, Pennsylvania, 18704, United States

Location

Chattanooga Oncology and Hematology Assoicates, PC

Chattanooga, Tennessee, 37404, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Texas Oncology, P.A.

Bedford, Texas, 76022, United States

Location

Center for Oncology Research and Treatment, PA

Dallas, Texas, 75230, United States

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Texas Cancer Center ( Medical City Dallas Hospital)

Dallas, Texas, 75230, United States

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Texas Oncology Presbyterian Hospital

Dallas, Texas, 75246, United States

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Texas Oncology Sammons Cancer Center

Dallas, Texas, 75246, United States

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Texas Oncology Texas Oncology PA

Dallas, Texas, 75251, United States

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Texas Cancer Center Denton

Denton, Texas, 76210, United States

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El Paso Cancer Treatment Ctr-East

El Paso, Texas, 79915, United States

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Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

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San Antonio Tumor and Blood Clinic

Fredericksburg, Texas, 78624, United States

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MD Anderson Cancer Center/University of Texas

Houston, Texas, 77030, United States

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Longview Cancer Center

Longview, Texas, 75601, United States

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South Texas Cancer Center- McAllen

McAllen, Texas, 78503, United States

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Allison Cancer Center

Midland, Texas, 79701-5946, United States

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Texas Cancer Center- Sherman

Sherman, Texas, 75090-0504, United States

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Tyler Cancer Center

Tyler, Texas, 75702, United States

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Waco Cancer and Research Center

Waco, Texas, 76712, United States

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Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031, United States

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Northwest Cancer Specialists, P.C.

Vancover, Washington, 98664, United States

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Novartis Investigative Site

Garran, Australian Capital Territory, 2605, Australia

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Port Macquarie, New South Wales, 2444, Australia

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Randwick, New South Wales, 2031, Australia

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Sydney, New South Wales, 2060, Australia

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Tweed Heads, New South Wales, 2485, Australia

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Waratah, New South Wales, 2298, Australia

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Nambour, Queensland, 4560, Australia

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Redcliff, Queensland, 4020, Australia

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Adelaide, South Australia, 5000, Australia

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Toorak Gardens, South Australia, 5065, Australia

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Box Hill, Victoria, 3128, Australia

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East Bentleigh, Victoria, 3165, Australia

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Epping, Victoria, 3076, Australia

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Footscray, Victoria, 3011, Australia

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Franston, Victoria, 3199, Australia

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Malvern, Victoria, 3144, Australia

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Parkville, Victoria, 3050, Australia

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Wodonga, Victoria, 3690, Australia

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Nedlands, Western Australia, 6009, Australia

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Perth, Western Australia, 6000, Australia

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Perth, Western Australia, 6005, Australia

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Auckland, Australia

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Dunedin, Australia

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Hamilton, 3240, Australia

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Graz, Austria, A-8036, Austria

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Vienna, Austria, 1090, Austria

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Wels, Austria, A-4600, Austria

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Feldkirch, A-6807, Austria

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Friesach, 9360, Austria

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Graz, 8036, Austria

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Güssing, 7540, Austria

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Innsbruck, 6020, Austria

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Leoben, A-8700, Austria

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Linz, 4010, Austria

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Linz, A-4020, Austria

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Salzburg, 5020, Austria

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Vienna, A-1090, Austria

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Vienna, A-1140, Austria

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Villach, 9500, Austria

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Wiener Neustadt, 2700, Austria

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Aalst, 9300, Belgium

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Antwerp, 2020, Belgium

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Bonheiden, 2820, Belgium

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Brasschaat, 2930, Belgium

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Bruges, 8000, Belgium

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Brussels, 1070, Belgium

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Ghent, 9000, Belgium

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Libramont, 6800, Belgium

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Liège, 4000, Belgium

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Turnhout, 2300, Belgium

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Verviers, 4800, Belgium

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Wilrijk, 2610, Belgium

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Newmarket, Ontario, L3Y 2P7, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M4C 3E7, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H1T 2M4, Canada

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Québec, Quebec, G1S 4L8, Canada

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Regina, Saskatchewan, S4T 7T1, Canada

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Saskatoon, Saskatchewan, S7N 4H4, Canada

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Tianjin, Tianjin Municipality, 300060, China

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Beijing, 100021, China

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Guangzhou, 510060, China

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Shanghai, 200032, China

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Aalborg, Denmark, DK-9000, Denmark

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Copenhagen, DK-2100, Denmark

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Herlev, DK-2730, Denmark

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Herning, DK-7400, Denmark

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Hillerød, DK-3400, Denmark

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Næstved, DK-4700, Denmark

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Odense C, DK-5000, Denmark

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Roskilde, DK-4000, Denmark

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Vejle, DK-7100, Denmark

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Viborg, DK-8800, Denmark

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Angers, 49033, France

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Caen, 14021, France

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Créteil, 94010, France

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Le Chesnay, 78157, France

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Lyon, F-69373, France

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Marseille, 13008, France

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Montbéliard, 25209, France

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Montpellier, F-34094, France

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Nice, 06050, France

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Perpignan, 66000, France

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Périgueux Cédex, 24004, France

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Rennes, 35062, France

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Strasbourg, 67091, France

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Toulouse, 31078, France

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Kiel, Germany, 24105, Germany

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Amberg, 92224, Germany

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Bayreuth, 95445, Germany

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Berlin, 10317, Germany

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Berlin, 10365, Germany

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Berlin, 10713, Germany

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Berlin, 10967, Germany

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Berlin, 13125, Germany

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Berlin, 13353, Germany

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Bremen, 28205, Germany

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Düsseldorf, 40225, Germany

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Erlangen, 91054, Germany

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Essen, 45147, Germany

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Frankfurt, 65929, Germany

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Freiburg im Breisgau, 79106, Germany

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Freiburg im Breisgau, 79110, Germany

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Halle, 06120, Germany

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Hanover, 30559, Germany

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Hanover, 30625, Germany

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Homburg, 66421, Germany

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Jena, 07740, Germany

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Lübeck, 23538, Germany

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Lüneburg, 21339, Germany

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Magdeburg, 39108, Germany

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München, 80336, Germany

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München, 81675, Germany

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Münster, 48149, Germany

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Offenbach, 63069, Germany

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Regensburg, 93053, Germany

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Trier, 54290, Germany

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Tübingen, 72076, Germany

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Ulm, 89070, Germany

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Wiesbaden, 65189, Germany

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Wiesbaden, D-65199, Germany

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Witten, 58452, Germany

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Galway, Ireland, Ireland

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Cork, Ireland

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Dublin, DUBLIN 9, Ireland

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Dublin, Ireland

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Letterkenny, Ireland

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Limerick, Ireland

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Jerusalem, 9112001, Israel

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Rehovot, 76100, Israel

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Tel Aviv, 6423906, Israel

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Tel Litwinsky, 52621, Israel

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Montevarchi, AR, 52025, Italy

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Bari, BA, 70126, Italy

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Biella, BI, 13051, Italy

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Bologna, BO, 40138, Italy

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Chieti, CH, 66100, Italy

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Catania, CT, 95124, Italy

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Antella - Bagno A Ripoli, FI, 50011, Italy

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Forlì, FO, 47100, Italy

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Milan, MI, 20121, Italy

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Milan, MI, 20132, Italy

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Modena, MO, 41100, Italy

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Aviano, PN, 33081, Italy

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Parma, PR, 43100, Italy

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Roma, RM, 00135, Italy

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Roma, RM, 00167, Italy

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Roma, RM, 00168, Italy

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Castelfranco Veneto, TV, 31033, Italy

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Udine, UD, 33100, Italy

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Verona, VR, 37126, Italy

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Fermo, 63122, Italy

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Nagoya, Aichi-ken, 464-8681, Japan

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Matsuyama, Ehime, 791-0280, Japan

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Fukuoka, Fukuoka, 811-1395, Japan

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Kitakyushu, Fukuoka, 802-0077, Japan

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Maebashi, Gunma, 371-8511, Japan

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Sapporo, Hokkaido, 003-0804, Japan

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Isehara, Kanagawa, 259-1193, Japan

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Kawasaki, Kanagawa, 216-8511, Japan

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Yokohama, Kanagawa, 241-8515, Japan

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Kyoto, Kyoto, 606-8507, Japan

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Osaka, Osaka, 537-8511, Japan

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Suita, Osaka, 565-0871, Japan

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Kitaadachi-gun, Saitama, 362-0806, Japan

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Shizuoka, Shizuoka, 420-8527, Japan

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Shimotsuke, Tochigi, 329-0498, Japan

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Bunkyo-ku, Tokyo, 113-8677, Japan

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Chuo-ku, Tokyo, 104-0045, Japan

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Chuo-ku, Tokyo, 104-8560, Japan

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Koto, Tokyo, 135-8550, Japan

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Shinjuku-ku, Tokyo, 160-0023, Japan

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Eindhoven, 5623 EJ, Netherlands

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Enschede, 7511 JH, Netherlands

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Nijmegen, 6532 SZ, Netherlands

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Rotterdam, 3083 AN, Netherlands

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Veldhoven, 5504 DB, Netherlands

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Skien, NO-3710, Norway

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Goyang-si, Gyeonggi-do, 410-769, South Korea

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Seoul, Korea, 06351, South Korea

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Seoul, 01812, South Korea

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Alicante, Alicante, 03010, Spain

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Málaga, Andalusia, 29010, Spain

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Seville, Andalusia, 41013, Spain

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Sabadell, Barcelona, 08208, Spain

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Santander, Cantabria, 39008, Spain

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A Coruña, Galicia, 15006, Spain

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A Coruña, Galicia, 15009, Spain

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Madrid, Madrid, 28040, Spain

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Valencia, Valencia, 46009, Spain

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Zaragoza, Zaragoza, 50009, Spain

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Lund, 221 85, Sweden

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Stockholm, SE-118 83, Sweden

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Uppsala, SE-751 85, Sweden

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Chur, 7000, Switzerland

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Lucerne, 6000, Switzerland

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Schaffhausen, 8208, Switzerland

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Winterthur, 8401, Switzerland

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Hull, East Yorkshire, HU8 9HE, United Kingdom

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Glasgow, Glasgow, G11 6NT, United Kingdom

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Northwood, Middlesex, HA6 2RN, United Kingdom

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Belfast, BT9 7AB, United Kingdom

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Bournemouth, BH7 7DW, United Kingdom

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Bristol, BS16 1JE, United Kingdom

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Chelmsford, CM1 7ET, United Kingdom

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Colchester, CO3 3NB, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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London, N18 1QX, United Kingdom

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London, NW3 2QG, United Kingdom

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Manchester, M23 9LT, United Kingdom

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Merseyside, L63 4JY, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Rhyl, LL18 5UJ, United Kingdom

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Sheffiled, S10 2SJ, United Kingdom

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Shrewsbury, SY38XQ, United Kingdom

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Surrey, SM2 5PT, United Kingdom

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 3, 2005
• Study Start: December 1, 2005
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 19, 2016
• Results First Posted: October 9, 2015

Record last verified: 2016-03

Locations

FR (14); GB (18); SE (3); BE (12); NO (1); CA (8); CH (4); US (42); IT (20); KR (3); DE (35); AU (16); JP (20); NL (5); DK (10); IL (4); ES (10); IE (6); CN (4)