Cryosurgery in Treating Women With Breast Lesions - Full Text View

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Procedure: conventional surgery Procedure: cryosurgery	Phase I

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 2001

Detailed 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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020852

Locations


United States, California
	Jonsson Comprehensive Cancer Center, UCLA
	Los Angeles, California, United States, 90095-7028

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators


Principal Investigator:	Helena R. Chang, MD, PhD	Jonsson Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000068724, UCLA-9908076, NCI-G01-1964
First Received:	July 11, 2001
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00020852
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer

stage II breast cancer

Study placed in the following topic categories:

Skin Diseases

Breast Neoplasms

Breast Diseases

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Site

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00020852