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

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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



- 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.


- 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.

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
palpable or visualized by USS can be treated.

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
associated with invasive breast cancer, which would go undetected if the lesion is
entirely destroyed by the RF ablation.

Type of Study:


Study Design:

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

Outcome Measure:

Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis and amount of tumor coagulated at post-treatment biopsy

Outcome Time Frame:

At completion of study

Safety Issue:


Principal Investigator

Vijay Khatri, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of California, Davis


United States: Federal Government

Study ID:




Start Date:

October 2001

Completion Date:

May 2007

Related Keywords:

  • Breast Cancer
  • ductal breast carcinoma in situ
  • stage I breast cancer
  • stage II breast cancer
  • breast cancer in situ
  • Breast Neoplasms
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating



University of California Davis Cancer Center Sacramento, California  95817