Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
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Trial Identification
Brief Title: A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Official Title: A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.
Study ID: NCT00391092
Conditions
Study Description
Brief Summary: This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Buenos Aires, , Argentina
, Cordoba, , Argentina
, La Plata, , Argentina
, Mar del Plata, , Argentina
, Mendoza, , Argentina
, Salta, , Argentina
, San Martin, , 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
, Vöcklabruck, , Austria
, Wien, , Austria
, Banja Luka, , Bosnia and Herzegovina
, Sarajevo, , Bosnia and Herzegovina
, Tuzla, , Bosnia and Herzegovina
, Goiania, GO, Brazil
, Porto Alegre, RS, Brazil
, Florianopolis, SC, Brazil
, Barretos, SP, Brazil
, Sao Paulo, SP, Brazil
, Calgary, Alberta, Canada
, Vancouver, British Columbia, Canada
, Halifax, Nova Scotia, Canada
, Hamilton, Ontario, Canada
, Sudbury, Ontario, Canada
, Toronto, Ontario, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Saskatoon, Saskatchewan, Canada
, Quebec, , Canada
, Praha 2, , Czech Republic
, Praha 5, , Czech Republic
, Avignon, , France
, Besancon, , 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
, Milano, Lombardia, Italy
, Pavia, Lombardia, Italy
, Acapulco, , Mexico
, Guadalajara, , Mexico
, Merida, , Mexico
, Monterrey, , Mexico
, Torreon, , Mexico
, Bucharest, , Romania
, Bucuresti, , Romania
, Cluj Napoca, , Romania
, Cluj-Napoca, , Romania
, Iasi, , Romania
, Kazan, , Russian Federation
, Moscow, , Russian Federation
, Obninsk, , Russian Federation
, Ryazan, , Russian Federation
, Saint-Petersburg, , Russian Federation
, UFA, , Russian Federation
, Sabadell, Barcelona, Barcelona, Spain
, Barcelona, , Spain
, Cordoba, , Spain
, Madrid, , Spain
, Zaragoza, , Spain
, Izmir, , Turkey
, Sıhhiye, ANKARA, , Turkey
, 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
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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