Status:
COMPLETED
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line th...
Eligibility Criteria
Inclusion
- Female patients, \>/= 18 years of age
- Histologically confirmed HER2-negative breast cancer
- Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
- Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
- ECOG performance status 0-2
- At least 28 days since prior radiation therapy or surgery and recovery from treatment
Exclusion
- Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
- Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
- Inadequate renal function
- Clinically relevant cardio-vascular disease
- Known CNS disease except for treated brain metastases
- Chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
- Pregnant or lactating women
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT01250379
Start Date
February 1 2011
End Date
March 1 2015
Last Update
February 11 2016
Active Locations (132)
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1
Buenos Aires, Argentina, C1199ACI
2
Buenos Aires, Argentina, C1280AEB
3
Buenos Aires, Argentina, C1426ANZ
4
San Miguel de Tucumán, Argentina, T4000IAK