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

Sponsor

University of California, Davis (Other)

Overall Status

Completed

CT.gov ID

NCT00388115

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arm

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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.

Study Design

Study Type:

Interventional

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 :

Oct 1, 2001

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

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 Names: RFA

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 Names:

RFA

Outcome Measures

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 [At completion of study]

Secondary Outcome Measures

Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy [At completion of study]
Number and proportion of patients with and without tumor in the margin [At completion of study]
Rate of acute skin toxicity [At completion of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.