Trial Information

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

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.