Trial information
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
Status: Completed
Protocol number: ML19869
Sponsor: Roche PA
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the effect of Avastin in combination with Docetaxel and Xeloda on response rate in the neoadjuvant treatment of breast cancer patients.
Brief summary: This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
18.
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 complete response rate
Key secondary outcomes: 1. Efficacy: Clinical objective response rate; rate of breast-conserving surgery. Safety: Serious and specific AEs
Inclusion criteria:
- female patients, 18-70years of age;
- histologically-proven invasive breast cancer;
- no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
- no distant disease/secondary cancer.
Exclusion criteria:
- pregnant or lactating women;
- pre-operative local treatment for breast cancer;
- prior or concurrent systemic antitumor therapy;
- clinically significant cardiac disease.
Gender: Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Trial registration date: 03/10/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Austria
