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

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Chemotherapy; Drug: bevacizumab [Avastin]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01250379

MO22998

2010-020998-16

Details and patient eligibility

About

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.

Enrollment: 494 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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494 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: Chemotherapy

2

Experimental group

Treatment:

Drug: bevacizumab [Avastin]

Drug: Chemotherapy