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