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Brief Title: A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
Official Title: A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer
Study ID: NCT00811135
Brief Summary: This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Herlev, , Denmark
, Vejle, , Denmark
, Aix En Provence, , France
, Beziers, , France
, Creteil, , France
, Dechy, , France
, Lormont, , France
, Marseille, , France
, Narbonne, , France
, Paris, , France
, Paris, , France
, Paris, , France
, Paris, , France
, Rodez, , France
, Saint Jean, , France
, Saint Quentin, , France
, Toulouse, , France
, Moscow, , Russian Federation
, Moscow, , Russian Federation
, Saint-Petersburg, , Russian Federation
, Bratislava, , Slovakia
, Barakaldo, Vizcaya, Spain
, Barcelona, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Malaga, , Spain
, Pontevedra, , Spain
, Salamanca, , Spain
, Sevilla, , Spain
, Valencia, , Spain
, Valencia, , Spain
, Eskilstuna, , Sweden
, Sundsvall, , Sweden
, Uppsala, , Sweden
, Vaxjo, , Sweden
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR