Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer

Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy
and heat treatment for recurrent breast cancer located on the chestwall following
mastectomy. This protocol also includes patients with metastatic breast cancer who have not
had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug
adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a
small amount of lipid (fat). This chemotherapy is in a newer form which can be better
delivered to the tumor tissue without causing as much systemic toxicity. We are combining
heat treatment with this drug in an effort to further increase the delivery of drug to the
tumor, which may give an increased tumor response.

Methods: The patients will be treated with chemotherapy followed by heat treatment. This
will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will
need to be hospitalized 3 days for measurement of blood levels of drug as well as some
additional radiology studies which will help us to determine whether the drug is
preferentially distributed within tumor.