COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH:
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00388115
Recruitment Status : Completed
First Posted : October 13, 2006
Last Update Posted : March 29, 2010
National Cancer Institute (NCI)
Information provided by:
University of California, Davis

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: conventional surgery Procedure: neoadjuvant therapy Procedure: radiofrequency ablation Not Applicable

Detailed Description:



  • 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer
Study Start Date : October 2001
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: RFA prior to surgery Procedure: conventional surgery
Standard of care lumpectomy or mastectomy following RFA

Procedure: neoadjuvant therapy
Standard of care lumpectomy or mastectomy following RFA

Procedure: radiofrequency ablation
A small diameter needle is inserted through the skin and directly into the tumor for the purpose of supplying RF current. Initial power of the RF generator will start at 5-10 watts. The power will increase by 5-10 watts every minute until impedance of the system automatically stops the RF treatment.
Other Name: RFA

Primary Outcome Measures :
  1. 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 [ Time Frame: At completion of study ]

Secondary Outcome Measures :
  1. Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy [ Time Frame: At completion of study ]
  2. Number and proportion of patients with and without tumor in the margin [ Time Frame: At completion of study ]
  3. Rate of acute skin toxicity [ Time Frame: At completion of study ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00388115

Layout table for location information
United States, California
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
National Cancer Institute (NCI)
Layout table for investigator information
Principal Investigator: Vijay Khatri, MD University of California, Davis
Layout table for additonal information
Responsible Party: Vijay Khatri, MD, University of California, Davis Identifier: NCT00388115    
Other Study ID Numbers: CDR0000505536
P30CA093373 ( U.S. NIH Grant/Contract )
UCD-123 ( Other Identifier: University of California, Davis - Cancer Center )
UCD-200210277-6 ( Other Identifier: University of California, Davis - IRB )
First Posted: October 13, 2006    Key Record Dates
Last Update Posted: March 29, 2010
Last Verified: March 2010
Keywords provided by University of California, Davis:
ductal breast carcinoma in situ
stage I breast cancer
stage II breast cancer
breast cancer in situ
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Carcinoma in Situ
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type