A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
NCT ID: NCT00391092
Last Updated: 2015-08-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
424 participants
INTERVENTIONAL
2006-09-30
2014-08-31
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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1
bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Docetaxel
100mg/m2 iv every 3 weeks
Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
2
Docetaxel
100mg/m2 iv every 3 weeks
Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Interventions
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bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Docetaxel
100mg/m2 iv every 3 weeks
Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Eligibility Criteria
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Inclusion Criteria
* HER2 positive breast cancer with locally recurrent or metastatic lesions;
* eligible for chemotherapy;
* baseline LVEF \>=50%.
Exclusion Criteria
* previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
* other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
* clinically significant cardiovascular disease;
* chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day).
18 Years
ALL
No
Sponsors
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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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Buenos Aires, , Argentina
Córdoba, , Argentina
La Plata, , Argentina
Mar del Plata, , Argentina
Mendoza, , Argentina
Salta, , Argentina
San Martín, , Argentina
Santa Fe, , Argentina
Santa Fe, , Argentina
Lismore, New South Wales, Australia
Newcastle, New South Wales, Australia
Port Macquarie, New South Wales, Australia
Wahroonga, New South Wales, Australia
Wollongong, New South Wales, Australia
Auchenflower, Queensland, Australia
Nambour, Queensland, Australia
Fitzroy, Victoria, Australia
Geelong, Victoria, Australia
Perth, Western Australia, Australia
Graz, , Austria
Salzburg, , Austria
Vienna, , Austria
Vöcklabruck, , Austria
Banja Luka, , Bosnia and Herzegovina
Sarajevo, , Bosnia and Herzegovina
Tuzla, , Bosnia and Herzegovina
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Florianópolis, Santa Catarina, Brazil
Barretos, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Greater Sudbury, Ontario, Canada
Hamilton, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Prague, , Czechia
Prague, , Czechia
Avignon, , France
Besançon, , France
Bordeaux, , France
Caen, , France
Clermont-Ferrand, , France
Dijon, , France
Lille, , France
Montpellier, , France
Villejuif, , France
Parma, Emilia-Romagna, Italy
Udine, Friuli Venezia Giulia, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Acapulco, , Mexico
Guadalajara, , Mexico
Mérida, , Mexico
Monterrey, , Mexico
Torreón, , Mexico
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Iași, , Romania
Kazan', , Russia
Moscow, , Russia
Obninsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Ufa, , Russia
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Barcelona, Spain
Córdoba, Cordoba, Spain
Madrid, Madrid, Spain
Zaragoza, Zaragoza, Spain
Izmir, , Turkey (Türkiye)
Sıhhiye, Ankara, , Turkey (Türkiye)
Exeter, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Preston, , United Kingdom
Rhyl, , United Kingdom
Stoke-on-Trent, , United Kingdom
Weston-super-Mare, , United Kingdom
Montevideo, , Uruguay
Montevideo, , Uruguay
Countries
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References
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Gianni L, Romieu GH, Lichinitser M, Serrano SV, Mansutti M, Pivot X, Mariani P, Andre F, Chan A, Lipatov O, Chan S, Wardley A, Greil R, Moore N, Prot S, Pallaud C, Semiglazov V. AVEREL: a randomized phase III Trial evaluating bevacizumab in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive locally recurrent/metastatic breast cancer. J Clin Oncol. 2013 May 10;31(14):1719-25. doi: 10.1200/JCO.2012.44.7912. Epub 2013 Apr 8.
Other Identifiers
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BO20231
Identifier Type: -
Identifier Source: org_study_id
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