Cryosurgery in Treating Women With Breast Lesions

Jonsson Comprehensive Cancer Center

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: conventional surgery; Procedure: cryosurgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00020852

NCI-G01-1964

UCLA-9908076

CDR0000068724 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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