ABI-007 in Taxol Resistant Patients With Metastatic Breast Cancer
Breast Neoplasms, Metastases, Neoplasm
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Metastatic Breast Cancer, Taxol
Eligibility Criteria
Patients must be: If female, non-pregnant and not lactating, with a negative serum pregnancy test, and either not of child-bearing potential or practicing an approved contraception method Eighteen years of age or older Karnofsky Perfomance Status of 70% or 0-2 SWOG Performance Status No other malignancy, except non-melanoma skin cancer, CIN, or in-situ cervical cancer Measurable disease Suitable candidate for treatment with paclitaxel Previously treated with Taxol weekly or every three weeks, including adjuvant therapy, for metastatic breast cancer and relapsed within 12 months If, at baseline, patient has absolute neutrophil count of at least 1500 cells/mm3, platelet count of at least 100,000 cells/mm3,and hemoglobin of at least 9 g/dL If, at baseline, patient has AST and ALT of less than or equal to 2.5 x the upper limit of normal range; a total bilirubin less than or equal to 1.5 mg/dL; creatinine levels less than or equal to 2 mg/dL; and alkaline phosphatase levels less than or equal to 5 x the upper limit of normal range (unless there are bone but not liver metastases) Patient has an expected survival of at least 12 weeks Patient or his/her representative has signed an informed consent statement
Sites / Locations
- Abraxis BioScience, Inc.