Status:
COMPLETED
A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
2296 Patients enrolled
Trial Details
Trial ID
NCT00448591
Start Date
September 1 2006
End Date
February 1 2013
Last Update
May 25 2015
Active Locations (457)
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1
Buenos Aires, Argentina, 1406
2
Buenos Aires, Argentina, 1878
3
La Plata, Argentina, B1902CMK
4
Rosario, Argentina, S2002KDS