Cryosurgery in Treating Women With Breast Lesions - Tabular View

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Cryosurgery in Treating Women With Breast Lesions

This study has been completed.

Study NCT00020852. Last updated on July 23, 2008. Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Cryosurgery in Treating Women With Breast Lesions

Official Title ^†

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

Brief 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.

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.

Study Phase

Phase I

Study Type ^†

Interventional

Study Design ^†

Treatment

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Breast Cancer

Intervention ^†

Procedure: conventional surgery
Procedure: cryosurgery

MEDLINE PMIDs

Links

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

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

May 2001

Completion Date

Eligibility 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

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00020852

Organization ID

CDR0000068724

Secondary IDs ^††

UCLA-9908076, NCI-G01-1964

Study Sponsor ^†

Jonsson Comprehensive Cancer Center

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Principal Investigator:

Helena R. Chang, MD, PhD

Jonsson Comprehensive Cancer Center

Information Provided By

National Cancer Institute (NCI)

Verification Date

May 2004

First Received Date ^†

July 11, 2001

Last Updated Date

July 23, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.