A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer (BATMAN)

Roche

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Bevacizumab; Drug: Paclitaxel; Drug: Docetaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01094184

ML22780

2009-014279-37

Details and patient eligibility

About

This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.

Enrollment: 49 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease
• Participant who in the Investigator's opinion requires combination therapy for their disease
• Life expectancy of greater than or equal to (>/=)12 weeks

Exclusion criteria

• Previous chemotherapy for metastatic breast cancer
• Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
• Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Bevacizumab 10 mg/kg Q2W

Experimental group

Description:

Participants will receive bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

Treatment:

Drug: Docetaxel

Drug: Paclitaxel

Drug: Bevacizumab

Bevacizumab 15 mg/kg Q3W

Experimental group

Description:

Participants will receive bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.

Treatment:

Drug: Docetaxel

Drug: Paclitaxel

Drug: Bevacizumab