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

Study Overview
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Brief Summary
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RATIONALE: Microwave thermotherapy kills tumor cells by heating them to several degrees above body temperature. PURPOSE: Randomized phase II trial to compare the effectiveness of microwave thermotherapy before surgery to that of surgery alone in treating women who have stage I or stage II breast cancer.

Detailed Description
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OBJECTIVES: Compare the safety and efficacy of preoperative focused microwave thermotherapy followed by surgery vs surgery alone in women with early-stage primary breast cancer. Compare the reduction of tumor cells at surgical margins and second incision rates in women treated with these regimens. Compare the percentage of pathological cell death in women treated with these regimens. Compare the amount of surgically removed breast and tumor tissue in women treated with these regimens. Compare the measurement of the extent tumor margins of the surgically removed breast and tumor tissue in women treated with these regimens. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to tumor classification (T1 vs T2) and participating center. Patients are randomized to 1 of 2 treatment arms. Arm I:Patients undergo ultrasound-guided placement of a microwave sensor and a temperature probe (before or after compression of the breast) and external placement of 2 large opposing microwave emitters and up to 7 skin temperature sensors on the compressed breast. Patients then receive focused microwave thermotherapy that slowly heats the primary breast tumor and deep proximal breast tissue. In the absence of undue heating of the skin, a tumor temperature of 48-52° C is targeted and maintained for an equivalent thermal dose of 140-180 minutes. Within 60 days of thermotherapy, patients undergo lumpectomy. Arm II: Patients undergo lumpectomy only. Patients are followed at 30 and 90 days after surgery, and then at the discretion of the physician. PROJECTED ACCRUAL: A total of 200-222 patients (100-111 per treatment arm) will be accrued for this study.

Official Title
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A Randomized Pivotal Clinical Trial In Breast Cancer Patients Of Pre-Operative Focal Microwave Thermotherapy Treatment For Early-Stage Breast Disease In Intact Breast

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: conventional surgery
* Procedure: neoadjuvant therapy
* Procedure: thermal ablation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: conventional surgery|nan|
|Procedure: neoadjuvant therapy|nan|
|Procedure: thermal ablation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer