Status:
COMPLETED
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic bre...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- breast cancer with measurable locally recurrent or metastatic lesions;
- candidate for chemotherapy;
- HER2-positive disease;
- ECOG PS of \<=2.
Exclusion
- previous anticancer therapy for metastatic breast cancer;
- previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy \>=6 months before enrollment);
- chronic daily treatment with corticosteroids (\>=10mg/day), aspirin (\>325 mg/day) or clopidogrel (\>75mg/day);
- other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
- uncontrolled hypertension or significant cardiovascular disease.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00811135
Start Date
December 1 2008
End Date
December 1 2015
Last Update
September 29 2016
Active Locations (35)
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1
Herlev, Denmark, 2730
2
Vejle, Denmark, 7100
3
Aix-en-Provence, France, 13616
4
Béziers, France, 34500