Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation
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.
OBJECTIVES:
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.
DISEASE CHARACTERISTICS:
Highly suspicious breast lesion on prior mammogram and/or ultrasound with confirmation of malignancy on ultrasound-guided core biopsy
Eligible for lumpectomy or mastectomy
No superficial breast lesions
No prior open surgical biopsy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other: