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Cryosurgery in Treating Women With Breast Lesions



Cryosurgery in Treating Women With Breast Lesions

For Condition: stage 1 breast cancer,stage 2 breast cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
HelenaChang,  Principal Investigator,  Jonsson Comprehensive Cancer Center

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-7028
United States
Recruiting Helena  Chang 310-794-5640


Additional Information:
Study ID Numbers:
  CDR0000068724;  NCI-G01-1964,UCLA-9908076
Study Start Date: 
Record last reviewed: January 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020852

Other Stage 1 Breast Cancer Studies:
1. MRI-Guided Ultrasound Energy in Treating Patients With Stage I, Stage II, or Stage IIIA Breast Cancer

2. Tamoxifen in Treating Women With Breast Cancer

3. Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer

4. Trastuzumab in Treating Women With Breast Cancer

5. Exemestane Compared With Anastrozole, With or Without Celecoxib, in Treating Postmenopausal Women After Surgery for Primary Breast Cancer

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