A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA)

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: Female

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 therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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