Radiofrequency Ablation in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ

Phase

N/A

Condition

Precancerous Condition

Cancer

Genitourinary Cancer

Treatment

N/A

Clinical Study ID

NCT00388115

CDR0000505536

UCD-123

P30CA093373

UCD-200210277-6

Ages > 18
All Genders

Study Summary

RATIONALE: Radiofrequency ablation uses a high-frequency, electric current to kill tumor cells. Giving radiofrequency ablation before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying how well radiofrequency ablation followed by surgery works in treating patients with early invasive breast cancer or ductal carcinoma in situ.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Females of ages ≥18 years.
Core biopsy proven invasive breast cancer OR
Core biopsy proven low or intermediate grade DCIS.
Tumor less than or equal to 2.0 cm in diameter.
No prior surgical treatment for breast cancer within 30 days.
Life expectancy of > 10 years, not including the diagnosis of cancer.
ECOG performance status of 0-2.
Informed consent given.
Multifocal invasive breast cancer patients are eligible. All tumors that are palpableor visualized by USS can be treated.

Exclusion

Exclusion Criteria:

Male subjects.
Ages < 18 years.
Breast tumor > 2.0 cm in diameter.
Evidence of distant metastatic disease.
Evidence of diffuse calcification suggestive of extensive or multifocal DCIS.
High grade DCIS or presence of comedo-necrosis because these lesions can be associatedwith invasive breast cancer, which would go undetected if the lesion is entirelydestroyed by the RF ablation.

Study Design

October 01, 2001

May 31, 2007

Study Description

OBJECTIVES:

Primary

Determine the effectiveness of radiofrequency ablation (RFA), in terms of amount of tumor coagulated and viable cell count, in patients with early invasive breast cancer or low- or intermediate-grade ductal carcinoma in situ.

Secondary

Determine the size, configuration, and pathological features of human breast tumors after treatment with RFA.
Determine whether RFA energy applied to breast cancer will result in cancer cell death.
Determine whether tumor-free margins are achieved by RFA in these patients.
Determine the rate of acute toxicities to skin after surgery in patients treated with this regimen.

OUTLINE: This is a pilot study.

Pre-radiofrequency ablation (RFA) procedures: Patients undergo staging by MRI assessment to determine the size of their tumor. Patients with nonpalpable lesions must undergo placement of a metallic clip in the center of their tumor and a hook wire to guide surgical excision by intraoperative ultrasound imaging. Patients with invasive breast cancer undergo axillary lymph node dissection or sentinel lymph node biopsy (SLNB) for axillary lymph node staging. Patients with ductal carcinoma in situ proceed directly to RFA/resection since they do not require axillary staging.
RFA: Patients undergo RFA comprising insertion of a multiple-needle electrode into the breast tumor under direct guidance of ultrasonography and the metallic clip placed preoperatively in the lesion.
Surgical resection of RFA area: After RFA is completed, the electrode is removed and patients undergo wide local excision of the residual tumor or mastectomy.

After completion of study therapy, patients are followed periodically for up to 4 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Connect with a study center

University of California Davis Cancer Center
Sacramento, California 95817
United States
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.