Trial Information
An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer
Inclusion Criteria:
- patients, >=18 years of age;
- HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic
disease; (HER-2 positive patients only if previously treated with Herceptin in the
adjuvant setting;
- candidates for chemotherapy.
Exclusion Criteria:
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- concomitant hormonal therapy for metastatic or locally recurrent disease;
- concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2
positive disease;
- previous radiotherapy for treatment of metastatic disease;
- evidence of CNS metastases.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of AEs, and SAEs related to Avastin
Outcome Time Frame:
Throughout study
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Australia: Joint Human Research Ethics Committee
Study ID:
MO19391
NCT ID:
NCT00448591
Start Date:
September 2006
Completion Date:
March 2011
Related Keywords:
- Breast Cancer
- Breast Neoplasms