Status:
COMPLETED
A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HE...
Eligibility Criteria
Inclusion
- Female patients, ≥ 18 years of age.
- Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
- HER-2 negative disease.
- Candidates for chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Exclusion
- Previous chemotherapy for metastatic or locally advanced breast cancer.
- Previous radiotherapy for treatment of metastatic breast cancer.
- Any prior adjuvant treatment with anthracyclines completed \< 6 months prior to enrollment.
- Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (\> 325 mg/day) or clopidogrel (\> 75mg/day).
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00846027
Start Date
January 1 2009
End Date
January 1 2013
Last Update
July 23 2014
Active Locations (23)
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1
Elda, Alicante, Spain, 03600
2
Barcelona, Barcelona, Spain, 08022
3
Barcelona, Barcelona, Spain, 08907
4
Manresa, Barcelona, Spain, 08243