A Phase I/II Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer

Key Inclusion Criteria: * Women 18 years or older * Histologically confirmed breast cancer * Clinical evidence of metastatic (stage IV) metastasis (other than bone metastasis) * Availability of estrogen and progesterone receptor status * At least one measurable disease site defined by RECIST criteria, 30 days prior to study therapy * For the phase 1, no more that 3 prior cytotoxic regimens for metastatic breast cancer. For the phase 2, no more than 2 prior cytotoxic regimens for metastatic breast cancer * Life expectancy ≥ 12 weeks * Eastern Cooperative Oncology Group performance status ≤2 * Women of child bearing potential must agree to 2 forms of contraception during the course of the trial. Key Exclusion Criteria: * Inability to understand/unwillingness to sign a written informed consent * Any significant side effects related to prior chemo, radiation, biology or hormonal therapy that did not resolve in the judgment of the investigator * Currently using an investigational agent * Clinically significant gastrointestinal abnormalities * Currently using coumadin at therapeutic doses or within 2 weeks of taking study medication * Concurrent palliative radiation or anti-cancer treatment * Women who report pregnancy, are breast-feeding or have a positive pregnancy test