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Brief Title: A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
Official Title: A Randomized, Open-label Study of the Effect of Herceptin Plus Arimidex Compared With Arimidex Alone on Progression-free Survival in Patients With HER2-positive and Hormone-receptor Positive Metastatic Breast Cancer
Study ID: NCT00022672
Brief Summary: This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal growth factor receptor-2 (HER2) overexpressing metastatic breast cancer (ER+ve and/or PR+ve). Patients were randomized to receive either anastrazole 1 mg per os (po) daily, or anastrazole 1 mg po daily + a loading dose of Herceptin® 4 mg/kg intravenous (iv) followed by weekly doses of Herceptin® 2 mg/kg iv. The anticipated time on study treatment was until disease progression, and the target sample size was 100-500 individuals.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
, Phoenix, Arizona, United States
, Little Rock, Arkansas, United States
, Los Angeles, California, United States
, Vallejo, California, United States
, Gainsville, Florida, United States
, Miami, Florida, United States
, Plantation, Florida, United States
, Chicago, Illinois, United States
, Chicago, Illinois, United States
, Kansas City, Kansas, United States
, Scarborough, Maine, United States
, Detroit, Michigan, United States
, Omaha, Nebraska, United States
, Hackensack, New Jersey, United States
, Albuquerque, New Mexico, United States
, Santa Fe, New Mexico, United States
, Rochester, New York, United States
, Cincinnati, Ohio, United States
, Cleveland, Ohio, United States
, Hershey, Pennsylvania, United States
, Box Hill, , Australia
, Darlinghurst, , Australia
, Waratah, , Australia
, Porto Alegre, , Brazil
, Plovdiv, , Bulgaria
, Sofia, , Bulgaria
, Stara Zagora, , Bulgaria
, Calgary, Alberta, Canada
, Edmonton, Alberta, Canada
, Victoria, British Columbia, Canada
, Winnipeg, Manitoba, Canada
, Oshawa, Ontario, Canada
, Toronto, Ontario, Canada
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Quebec City, Quebec, Canada
, Beijing, , China
, Beijing, , China
, Shanghai, , China
, Shanghai, , China
, Wuhan, , China
, Avignon, , France
, Nice, , France
, Frankfurt, , Germany
, Kiel, , Germany
, München, , Germany
, Trier, , Germany
, Hong Kong, , Hong Kong
, Budapest, , Hungary
, Ahmedabad, , India
, Bangalore, , India
, Chennai, , India
, Cuttack, , India
, Ludhiana, , India
, Mumbai, , India
, New Delhi, , India
, New Delhi, , India
, New Delhi, , India
, Haifa, , Israel
, Haifa, , Israel
, Petach Tikva, , Israel
, Ramat-gan, , Israel
, Rehovot, , Israel
, Tel Aviv, , Israel
, Genova, , Italy
, Vilnius, , Lithuania
, Guadalajara, , Mexico
, Mexico City, , Mexico
, Amsterdam, , Netherlands
, Rotterdam, , Netherlands
, Trondheim, , Norway
, Bialystok, , Poland
, Bydgoszcz, , Poland
, Gliwice, , Poland
, Krakow, , Poland
, Lodz, , Poland
, Szczecin, , Poland
, Warszawa, , Poland
, Warszawa, , Poland
, Barnaul, , Russian Federation
, Izhevsk, , Russian Federation
, Kazan, , Russian Federation
, Krasnodar, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, St Petersburg, , Russian Federation
, St Petersburg, , Russian Federation
, St Petersburg, , Russian Federation
, UFA, , Russian Federation
, Floracliffe, , South Africa
, Pretoria, , South Africa
, Barcelona, , Spain
, Córdoba, , Spain
, Girona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Mataro, , Spain
, Reus, , Spain
, Valencia, , Spain
, Boras, , Sweden
, Gaelve, , Sweden
, Stockholm, , Sweden
, Örebro, , Sweden
, Taipei, , Taiwan
, Taoyuan, , Taiwan
, Ankara, , Turkey
, Ankara, , Turkey
, Istanbul, , Turkey
, Istanbul, , Turkey
, Izmir, , Turkey
, Shhiye, Ankara, , Turkey
, Kiev, , Ukraine
, Kiev, , Ukraine
, Lvov, , Ukraine
, Odessa, , Ukraine
, Sumy, , Ukraine
, Zaporozhye, , Ukraine
, Cardiff, , United Kingdom
, Edinburgh, , United Kingdom
, Guildford, , United Kingdom
, Ipswich, , United Kingdom
, London, , United Kingdom
, London, , United Kingdom
, Manchester, , United Kingdom
, Merseyside, , United Kingdom
, Newcastle Upon Tyne, , United Kingdom
, Southampton, , United Kingdom
, Swansea, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR