Conditions: Breast Cancer
Keywords: Breast Cancer
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 102
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days. arm 2: Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle

Interventions: intervention 1: Liposomal Doxorubicin intervention 2: Docetaxel
Intervention descriptions: intervention 1: Liposomal Doxorubicin intervention 2: Docetaxel

Protocol document: