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