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Phase I Study of Cryosurgery in Women With Highly Suspicious Breast Lesions

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Cryosurgery in Treating Women With Breast Lesions

Basic Trial Information

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 Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Helena Chang, MD, PhD, Principal investigator
Ph: 310-794-5640; 888-798-0719
Email: hchang@mednet.ucla.edu

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.