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

Inclusion criteria

• Be 18 years or older and female.
• Have histologically or cytologically confirmed diagnosis of invasive adenocarcinoma originating in the breast.
• Have at least one target lesion per RECIST criteria
• If the patient has received adjuvant or neoadjuvant taxane therapy, the patient must not have relapsed with breast cancer within one year of completing this therapy.
• Have received prior chemotherapy in the adjuvant or metastatic setting with an anthracycline unless contraindicated.
• Have no other malignancy within the past five years, except non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or in-situ cervical cancer (CIS).
• Have the following hematology levels at Baseline:

• ANC greater than or equal to 1,500 x 106 cells/L;
• Platelets greater than or equal to 100 x 109 cells/L;
• Hgb greater than or equal to 90 g/L.
• Have the following chemistry levels at Baseline:

• AST (SGOT), ALT (SGPT) less than or equal to 2.5 x ULN if no evidence of liver metastases;
• AST (SGOT), ALT (SGPT) less than or equal to 5 x ULN if liver metastases are present;
• Total bilirubin less than or equal to 26 micromol/L (1.5 mg/dL);
• Creatinine less than or equal to 177 micromol/L (2 mg/dL); or 24-hour
• Alkaline phosphatase less than or equal to 5 x ULN (unless bone metastasis is present in the absence of liver metastasis).
• Have a life expectancy of greater than or equal to 12 weeks.
• Have an ECOG Performance status of 0-2.
• Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment.
• Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee -approved written informed consent form prior to receiving any study related procedure.

Exclusion criteria

• Patient has radiographic evidence of active (symptomatic, untreated) intraparenchymal brain metastases; any leptomeningeal metastases; or asymptomatic untreated intraparenchymal brain metastases requiring treatment.
• Patient has received more than 1 prior treatment with a non-taxane agent in the metastatic setting.
• The only evidence of metastasis is lytic or blastic bone metastases or pleural effusion or ascites.
• Patient has a known infection with human immunodeficiency virus or active viral hepatitis.
• Patient has active heart disease including myocardial infarction or congestive heart failure within the previous 6 months, symptomatic coronary artery disease, or uncontrolled arrhythmias.
• 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).
• Any active infection requiring parenteral or oral antibiotics.
• 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.
• Patient has pre-existing peripheral neuropathy of NCI-CTCAE Grade >1.
• Patient has received paclitaxel, docetaxel, or Abraxane because of metastatic carcinoma.
• Known hypersensitivity to paclitaxel, Cremophor EL, or liposomes.
• Pregnant or nursing female patients.
• Unwilling or unable to follow protocol requirements.