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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00388115
First received: October 12, 2006
Last updated: March 25, 2010
Last verified: March 2010
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Procedure: conventional surgery
Procedure: neoadjuvant therapy
Procedure: radiofrequency ablation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy [ Time Frame: At completion of study ] [ Designated as safety issue: No ]
  • Number and proportion of patients with and without tumor in the margin [ Time Frame: At completion of study ] [ Designated as safety issue: No ]
  • Rate of acute skin toxicity [ Time Frame: At completion of study ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: October 2001
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00388115

Locations
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)
Investigators
Principal Investigator: Vijay Khatri, MD University of California, Davis
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Vijay Khatri, MD, University of California, Davis
ClinicalTrials.gov Identifier: NCT00388115     History of Changes
Other Study ID Numbers: CDR0000505536, P30CA093373, UCD-123, UCD-200210277-6
Study First Received: October 12, 2006
Last Updated: March 25, 2010
Health Authority: United States: Federal Government

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:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on March 06, 2013