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

Breast Cancer Clinical Trial

Official title: A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma in Situ

• NCT number: NCT00388115
• Study type: Interventional
• Source: University of California, Davis
• Status: Completed
• Phase: N/A
• Start date: October 2001
• Completion date: May 2007