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Brief Title: A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)
Official Title: Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment
Study ID: NCT01156961
Brief Summary: This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR