NCT00907959

A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

A Phase 2 Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Bionovo · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators' proposed phase 2 clinical trial will be an open-label, non-randomized study among 80 women with metastatic breast cancer. The study treatment period will be up to twelve months and enrollment will be open at 10-15 clinical sites in the United States. In this Phase 2 trial, 40 participants with hormone receptor positive tumors and 40 with hormone receptor negative tumors will be enrolled and treated with BZL101 20 grams/day (10 grams BID). Hormone receptor positive will be defined as estrogen receptor (ER)+ and progesterone receptor (PR)+, ER+ and PR-, or ER- and PR+. Hormone receptor negative will be defined as ER- and PR-.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	BZL101	Oral BZL101 20 grams/day (10 grams BID).

Timeline

• Start date: 2012-01-01
• Primary completion: 2015-01-01
• Completion: 2015-07-01
• First posted: 2009-05-25
• Last updated: 2012-02-08

Locations

1 site across 1 country: United States