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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Docetaxel; Paclitaxel; Taxane

Criteria

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