Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information
Cryosurgery in Treating Women With Breast Lesions
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase I | Treatment | Completed | Any age | NCI | UCLA-9908076 NCI-G01-1964, NCT00020852 |
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.
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
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
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
Expected Enrollment
A maximum of 25 patients will be accrued for this study.
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.
Trial Lead Organizations
Jonsson Comprehensive Cancer Center at UCLA
 | | | ||
| Helena Chang, MD, PhD, Principal investigator | |
| ||
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| Registry Information | ||
| ||
| Official Title | Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation | |
| ||
| Trial Start Date | 2001-05-03 | |
| ||
| Registered in ClinicalTrials.gov | NCT00020852 | |
| ||
| Date Submitted to PDQ | 2001-05-08 | |
| ||
| Information Last Verified | 2004-05-18 | |
| ||
| NCI Grant/Contract Number | P30-CA16042 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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