Trial of Paclitaxel, Bevacizumab, and Enzastaurin Versus Paclitaxel, Bevacizumab and Placebo for Breast Cancer

A Randomized, Double-Blind, Phase 2 Trial of Paclitaxel Plus Bevacizumab and Enzastaurin Versus Paclitaxel Plus Bevacizumab and Placebo for Locally Recurrent or Metastatic Breast Cancer

The purpose of this study is to determine efficacy and safety of paclitaxel, bevacizumab and enzastaurin versus paclitaxel, bevacizumab, and placebo in participants who are diagnosed with locally recurrent or metastatic breast cancer.

Inclusion Criteria:

• Must have signed an inform consent document
• Have histologic or cytologic diagnosis of breast cancer with evidence of unresectable locally recurrent or metastatic disease
• Have not received any prior chemotherapy for locally recurrent or metastatic disease
• Have not had adjuvant or neoadjuvant taxane therapy within 12 months prior to assignment to study treatment
• Age 18 years or older at time of informed consent

Exclusion Criteria:

• Have any clinical evidence of central nervous system (CNS) metastases
• Have a history of seizure
• Have had a major surgical procedure within 4 weeks prior to assignment to study treatment
• Have had a minor surgical procedure, placement of an access device, or fine needle aspiration within 7 days prior to assignment to study treatment
• Have symptomatic peripheral vascular disease