A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

• Clinical response rate, breast-conservative surgery rate, disease-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
• AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

• Drug: bevacizumab [Avastin]
  15mg/kg iv on day 1 of each 3 week cycle
• Drug: Docetaxel
  75mg/m2 iv on day 1 of each 3 week cycle
• Drug: Xeloda
  2000mg/m2 po on days 1-15 of each 3 week cycle

Inclusion Criteria:

• female patients, >=18 years of age;
• HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
• ECOG performance status 0-1.

Exclusion Criteria:

• metastatic disease (stage IV);
• previous treatment for breast cancer;
• evidence of CNS metastasis;
• current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
• clinically significant cardiovascular disease.