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Brief Title: A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer
Official Title: A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy
Study ID: NCT00929240
Brief Summary: This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
, Fortaleza, CE, Brazil
, Belo Horizonte, MG, Brazil
, Rio de Janeiro, RJ, Brazil
, Ijui, RS, Brazil
, Porto Alegre, RS, Brazil
, Jau, SP, Brazil
, Santo Andre, SP, Brazil
, Sao Paulo, SP, Brazil
, Sao Paulo, SP, Brazil
, Beijing, , China
, Beijing, , China
, Beijing, , China
, Hangzhou, , China
, Hangzhou, , China
, Shanghai, , China
, Alexandria, , Egypt
, Cairo, , Egypt
, Amiens, , France
, Angers, , France
, Besancon, , France
, Bobigny, , France
, Dijon, , France
, Hyeres, , France
, Le Coudray, , France
, Lille, , France
, Paris, , France
, Paris, , France
, Perigueux, , France
, Rodez, , France
, St Priest En Jarez, , France
, Strasbourg, , France
, Hong Kong, , Hong Kong
, Hong Kong, , Hong Kong
, Bangalore, , India
, Hyderabad, , India
, Mumbai, , India
, Mumbai, , India
, New Delhi, , India
, New Delhi, , India
, Napoli, Campania, Italy
, Trieste, Friuli-Venezia Giulia, Italy
, Genova, Liguria, Italy
, Saronno, Lombardia, Italy
, Brindisi, Puglia, Italy
, Antella (FI), Toscana, Italy
, Bydgoszcz, , Poland
, Wroclaw, , Poland
, Dammam, , Saudi Arabia
, Jeddah, , Saudi Arabia
, Jeddah, , Saudi Arabia
, Alcoy, Alicante, Spain
, Sabadell, Barcelona, Barcelona, Spain
, Alcazar de S. Juan, Ciudad Real, Spain
, Barakaldo, Vizcaya, Spain
, Jaen, , Spain
, Malaga, , Spain
, Toledo, , Spain
, Valencia, , Spain
, Ankara, , Turkey
, Ankara, , Turkey
, Antalya, , Turkey
, Istanbul, , Turkey
, Sıhhiye, ANKARA, , Turkey
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR