Overview

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