Study of ABI-007 and Taxol in 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, Taxane
Eligibility Criteria
Patients will be eligible for this trial if: Female, non-pregnant, non-lactating, and, if of child-bearing potential, have a negative serum pregnancy test, and use approved contraception Sixteen years of age or older Histologically or cytologically confirmed breast cancer (stage III or IV) with evidence of inoperable local recurrence or metastasis, with measurable disease If patient has received taxane therapy as an adjuvant he/she has not relapsed within one year of completing adjuvant taxane No other malignancy present within the past 5 years, except non-melanoma skin cancer, cervical intraepithelial neoplasia or in-situ cervical cancer Suitable candidate for paclitaxel therapy Hematology levels at baseline of: absolute neutrophil count of at least 1500 cells/mm3; platelet count of at least 100,000 cells/mm3; hemoglobin of at least 9 g/dL Chemistry levels at baseline of: AST and ALT of less than or equal to 2.5 x the upper limit of normal, if no evidence of liver metastasis; total bilirubin of less than or equal to 1.5 mg/dL; creatinine of less than or equal to 2 mg/dL; alkaline phosphatase of less than or equal to 5 x the upper limit of normal, unless there is bone metastasis but not liver metastasis Expected survival of at least 12 weeks Patient or his/her representative has signed an informed consent form
Sites / Locations
- Abraxis Bioscience, Inc