Trial information
A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer.
Status: Recruiting
Protocol number: ML19884
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open label neoadjuvant study to assess the effect of Avastin on tumor response in patients with inflammatory or locally advanced breast cancer
Brief summary: This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and Avastin, before surgery and/or radiotherapy, in patients with inflammatory or locally advanced operable breast cancer. Patients will receive FEC, followed by paclitaxel, given concomitantly with Avastin (10mg/kg i.v. every 2 weeks). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
53.
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. Rate of pathological complete response Time frame: Event driven
Key secondary outcomes: 1. Objective response rate, disease-free interval, overall survival, rate of breast conservative surgery. Time frame: Event driven
2. AEs, laboratory parameters Time frame: Throughout study
Inclusion criteria:
- female patients, >=18 years of age;
- stage III, or inflammatory breast cancer;
- ER/PgR positive or negative and HER-2 negative;
- normal LVEF.
Exclusion criteria:
- previous chemotherapy/endocrine therapy;
- evidence of distant metastatic disease;
- other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
- chronic daily treatment with >325mg/day aspirin, or >75mg/day clopidogrel.
Gender: Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2008
Trial registration date: 11/14/2007
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Italy
- Cuneo
- Genova
- Mantova
- Napoli
- Negrar
- Pordenone
- Potenza
- Reggio Emilia
- Torino
