Breast Cancer Clinical Trial
Cryosurgery in Treating Women With Breast Lesions
Summary
RATIONALE: Cryosurgery kills cancer cells by freezing them. Cryosurgery followed by lumpectomy or mastectomy may be an effective treatment for breast lesions.
PURPOSE: Phase I trial to study the effectiveness of cryosurgery in treating women who have breast lesions.
Full Description
OBJECTIVES:
Determine the feasibility of temperature-monitored, ultrasound-guided cryosurgery in women with highly suspicious breast lesions.
Determine the safety of this procedure in these patients.
OUTLINE: This is a multicenter study.
Patients undergo cryoablation of up to two breast lesions. Within 3-21 days, patients undergo lumpectomy or mastectomy.
Patients are followed at 1, 4, 8, and 12 weeks after lumpectomy or mastectomy.
PROJECTED ACCRUAL: A maximum of 25 patients will be accrued for this study.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy
Tumor no greater than 2.0 cm in diameter
Eligible for lumpectomy or mastectomy
No superficial breast lesions
No prior open surgical biopsy
Hormone receptor status:
Not specified
PATIENT CHARACTERISTICS:
Age:
Any age
Sex:
Female
Menopausal status:
Not specified
Performance status:
Not specified
Life expectancy:
Not specified
Hematopoietic:
Not specified
Hepatic:
Not specified
Renal:
Not specified
Other:
No other illness that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
Not specified
Endocrine therapy:
Not specified
Radiotherapy:
Not specified
Surgery:
See Disease Characteristics
No other surgery that would preclude study participation
Other:
No other medical treatment that would preclude study participation
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There is 1 Location for this study
Los Angeles California, 90095, United States
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