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
NCT ID: NCT00022672
Last Updated: 2013-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
208 participants
INTERVENTIONAL
2001-01-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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trastuzumab + anastrozole
Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
trastuzumab (Herceptin®)
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
anastrazole (Arimidex®)
1 mg tablet taken orally daily
anastrozole
1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
anastrazole (Arimidex®)
1 mg tablet taken orally daily
Interventions
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trastuzumab (Herceptin®)
4mg/kg iv loading dose, followed by 2mg/kg iv weekly
anastrazole (Arimidex®)
1 mg tablet taken orally daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* metastatic breast cancer suitable for endocrine therapy;
* positive hormone receptor status;
* Human epidermal growth factor receptor 2 (HER2) overexpression.
Exclusion Criteria
* previous chemotherapy for metastatic disease;
* uncontrolled cardiac disease and history of cardiac failure.
18 Years
FEMALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Québec, 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
Petah 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
Warsaw, , Poland
Warsaw, , Poland
Barnaul, , Russia
Izhevsk, , Russia
Kazan', , Russia
Krasnodar, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Ufa, , Russia
Floracliffe, , South Africa
Pretoria, , South Africa
Barcelona, , Spain
Córdoba, , Spain
Girona, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Mataró, , Spain
Reus, , Spain
Valencia, , Spain
Borås, , Sweden
Gaelve, , Sweden
Örebro, , Sweden
Stockholm, , Sweden
Taipei, , Taiwan
Taoyuan District, , Taiwan
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Shhiye, Ankara, , Turkey (Türkiye)
Kiev, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Sumy, , Ukraine
Zaporizhzhya, , 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
Countries
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Other Identifiers
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BO16216
Identifier Type: -
Identifier Source: org_study_id
NCT00112450
Identifier Type: -
Identifier Source: nct_alias
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