Efficacy and Safety Study of LEP-ETU to Treat Metastatic Breast Cancer

Exclusion Criteria

• •1. Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any leptomeningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
• •2. Patient has received more than 1 prior treatment with a non-taxane agent in the metastatic setting.
• •3. The only evidence of metastasis is lytic or blastic bone metastases or pleural effusion or ascites.
• •4. Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
• •5. Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
• •6. Any condition which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug (e.g., uncontrolled bleeding or bleeding diathesis).
• •7. Any active infection requiring parenteral or oral antibiotics.
• •8. The patient receives treatment with any:
• •* Hormonal or other non-investigational agent therapy within 2 weeks prior to first dose of study drug;
• •* Herceptin, mitomycin, or nitrosoureas therapy within 6 weeks prior to first dose;
• •* Chemotherapy (except for palliative bisphosphonate therapy for bone pain which can be administered as clinically indicated) within 4 weeks prior to first dose study drug;
• •* Investigational drug or immunotherapy within 4 weeks prior to first dose study drug;
• •* Concurrent radiation therapy (except for palliative radiotherapy for
• •* Radiation therapy within 4 weeks prior to first dose of study drug.
• •9. Patient has pre-existing peripheral neuropathy of NCI-CTCAE Grade \>1.
• •10. Patient has received paclitaxel, docetaxel, or Abraxane because of metastatic carcinoma.
• •11. Known hypersensitivity to paclitaxel, Cremophor EL, or liposomes.
• •12. Pregnant or nursing female patients.
• •13. Unwilling or unable to follow protocol requirements.