The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:
Liposomal Doxorubicin Docetaxel
For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.
To be included in this study, you must meet the following criteria:
Metastatic breast cancer confirmed by biopsy Prior adjuvant/neoadjuvant treatment allowed Measurable disease Able to perform activities of daily living with minimal assistance Age 18 years or older Adequate bone marrow, liver and kidney function Normal heart function Written informed consent
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
Pre-existing moderate peripheral neuropathy History of significant heart disease Meningeal metastases. Prior chemotherapy for metastatic breast cancer No measurable disease (including bone only, pleural effusions, etc.) Receiving Herceptin therapy. Women who are pregnant or lactating.
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
