Cryosurgery in Treating Women With Breast Lesions

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00020852
First received: July 11, 2001
Last updated: May 29, 2013
Last verified: May 2004

July 11, 2001
May 29, 2013
May 2001
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Complete list of historical versions of study NCT00020852 on ClinicalTrials.gov Archive Site
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Cryosurgery in Treating Women With Breast Lesions
Evaluation of Freezing Tumors in the Treatment of Breast Cancer Safety Study - 1-Probe CRYOcare Surgical System for Breast Tumor Ablation

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.

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.

Interventional
Phase 1
Primary Purpose: Treatment
Breast Cancer
  • Procedure: conventional surgery
  • Procedure: cryosurgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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July 2004
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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
Female
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020852
UCLA-9908076, CDR0000068724, NCI-G01-1964
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Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Helena R. Chang, MD, PhD Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP