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

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bionovo

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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-.