Status:
COMPLETED
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cance...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- HER2 positive breast cancer with locally recurrent or metastatic lesions;
- eligible for chemotherapy;
- baseline LVEF \>=50%.
Exclusion
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
- other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
- clinically significant cardiovascular disease;
- chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day).
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT00391092
Start Date
September 1 2006
End Date
August 1 2014
Last Update
August 28 2015
Active Locations (89)
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1
Buenos Aires, Argentina, 1417
2
Córdoba, Argentina, 5004
3
La Plata, Argentina, B1902CMK
4
Mar del Plata, Argentina, 7600