Temperature-Sensitive Liposomal Doxorubicin and Hyperthermia in Treating Women With Locally Recurrent Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast
• Locally recurrent disease involving the chest wall and/or its overlying skin
• Clinically and biopsy proven disease on the chest wall area measuring ≥ 1 cm
• Overall surface extent of tumor ≤ two 16 x 16 cm fields
• Tumor thickness ≤ 3 cm by clinical exam and CT scan or MRI
• Disease extent on the chest wall that exceeds the above criteria allowed provided no other local therapies are available
• Patients with axillary disease involvement only must meet the above criteria in order to be eligible
• Prior skin changes consistent with inflammatory breast cancer are allowed
• Distant metastasis (excluding known brain metastases) allowed
• No resectable chest wall recurrence as the only site of metastatic disease
• No refractory pain secondary to metastatic disease
• Must have undergone prior local radiotherapy to the chest wall or breast in the adjuvant or metastatic setting
• Must have progressed on ≥ 1 course of hormonal therapy for metastatic disease (if tumor is estrogen receptor positive or progesterone receptor positive) AND ≥ 1 course of chemotherapy
• Prior contralateral breast malignancy allowed provided not previously treated with chemotherapy
• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• Zubrod performance status 0-1 OR Karnofsky performance status 90-100%
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL
• Bilirubin normal
• alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan (MUGA) or echocardiogram
• No nonhealing wounds or active infection in the area of the chest wall
• No clinically significant findings on baseline evaluations, including laboratory and physical examinations, vital signs, and ECG
• No prior sensitivity (e.g., rash, dyspnea, wheezing, urticaria, or other symptoms) attributed to anthracyclines or other liposomally encapsulated drugs
• No other prior or concurrent primary malignancy except for melanoma in situ, nonmelanoma skin cancer, squamous cell carcinoma, or noninvasive cervical carcinoma
• No history of any of the following:
• Cardiac ischemia or acute coronary artery syndrome, myocardial infarction (MI), cerebral vascular accident, or abnormal cardiac stress testing within the last 6 months
• Coronary artery disease (including non-Q wave MI)
• Uncontrolled hypertension or cardiomyopathy
• Cardiac valvular surgery or open heart surgery
• Known structural heart disease
• No other serious medical illness including, but not limited to, the following:
• Congestive heart failure
• Life-threatening cardiac arrhythmias
• Acute or chronic liver disease
• No major psychiatric illness that required inpatient treatment within the past 3 months or that would preclude obtaining informed consent
• No concurrent devices or conditions that might interfere with the hyperthermia portion of the trial, including any of the following:
• Functioning cardiac pacemaker
• Metal plates, rods, or prosthesis of the chest wall
• Severe numbness and/or tingling of the chest wall or breast
• Skin grafts and/or flaps on the breast or chest wall
• Unstable cardiovascular or pulmonary status
• No known allergy to eggs or egg products

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 3 months since prior major surgery
• No prior therapy with anthracyclines exceeding the following doses:
• Doxorubicin hydrochloride > 450 mg/m^2
• Epirubicin hydrochloride > 900 mg/m^2
• More than 42 days since prior trastuzumab (Herceptin®)
• More than 90 days since prior radiotherapy to the involved chest wall area
• No other concurrent systemic anticancer therapy, including hormonal therapy, chemotherapy, or investigational anticancer therapy
• No concurrent radiotherapy, including radiotherapy for pain control
• No concurrent administration of any of the following drugs:
• Amphotericin B by injection
• Antithyroid agents
• Azathioprine
• Chloramphenicol
• Colchicine
• Flucytosine
• Ganciclovir
• Interferon
• Plicamycin
• Zidovudine
• Sulfinpyrazone
• Probenecid
• Cyclosporine
• Phenobarbital
• Phenytoin
• Streptozocin
• Live vaccines
• Concurrent bisphosphonates for palliation of bony metastasis allowed