Trial information
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
Status: No longer recruiting
Protocol number: ML20561
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: "An open label study to assess the effect of neoadjuvant treatment with docetaxel + Xeloda + Avastin on pathological response rate in inflammatory or locally advanced breast cancer"
Brief summary: 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. Target sample size is
33.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: bevacizumab [Avastin]
Primary outcome: 1. Pathological response rate Time frame: Event driven
Key secondary outcomes: 1. Clinical response rate, breast-conservative surgery rate, disease-free survival. Time frame: Event driven
2. AEs, laboratory parameters. Time frame: Throughout study
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.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: November, 2007
Trial registration date: 12/17/2007
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Spain
