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


Phase 1
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Helena R. Chang, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

UCLA-9908076

NCT ID:

NCT00020852

Start Date:

May 2001

Completion Date:

July 2004

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781