Microwave Thermotherapy in Treating Women With Stage I or Stage II Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed primary breast cancer by core needle biopsy
• •* T1a, b, c, or T2
• •* Diagnosis not made with a lumpectomy or incisional biopsy
• •Candidate for breast conservation surgery (lumpectomy/radiotherapy)
• •Tumor measurable by breast ultrasound
• •No metastatic disease, including skin metastases
• •No bilateral breast cancer
• •No high-probability of extensive intraductal disease in situ
• •No clinical fixation to the pectoralis major muscle or skin
• •No involvement of the nipple
• •No inflammatory breast cancer
• •No multicentric disease
• •Hormone receptor status:
• •* Not specified
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Sex:
• •Female
• •Menopausal status:
• •Not specified
• •Performance status:
• •Karnofsky 70-100%
• •Life expectancy:
• •At least 6 months
• •Hematopoietic:
• •Platelet count at least 100,000/mm\^3 (no thrombocytopenia)
• •No bleeding disorders
• •Hepatic:
• •PT, INR, and PTT less than 1.5 times normal
• •Bilirubin no greater than 2.0 mg/dL
• •Transaminases no greater than 2 times normal
• •No coagulopathy
• •No liver disease
• •Renal:
• •BUN less than 30 mg/dL
• •Creatinine less than 1.9 mg/dL
• •No renal insufficiency
• •Cardiovascular:
• •No pacemakers or defibrillators
• •No clinically significant heart disease
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use 2 forms of effective contraception, including 1 barrier method
• •Able to tolerate prone position and breast compression
• •No breast implants
• •No prior collagen vascular disease
• •No other factor or condition (other than tumor size) that would preclude lumpectomy
• •No mental condition that would preclude study
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Not specified
• •Chemotherapy:
• •Not specified
• •Endocrine therapy:
• •Not specified
• •Radiotherapy:
• •See Disease Characteristics
• •Surgery:
• •See Disease Characteristics
• •Other:
• •No prior participation in this study
• •More than 30 days since prior participation in another clinical study
• •No concurrent anticoagulants