Cryosurgery in Treating Women With Breast Lesions

Breast Cancer Clinical Trial

Official title:

Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00020852
• Other study ID #: UCLA-9908076
• Secondary ID: CDR0000068724NCI
• Status: Completed
• Phase: Phase 1
• First received: July 11, 2001
• Last updated: May 29, 2013
• Start date: May 2001
• Est. completion date: July 2004

Study information

• Verified date: May 2004
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• conventional surgery

• cryosurgery

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,