CompletedNCT00388115Updated Mar 29, 2010

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

An interventional study of conventional surgery and neoadjuvant therapy in Breast Cancer, sponsored by University of California, Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-29.

Sponsored by University of California, Davis · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Breast Cancer

Browse trials for

Keywords

ductal breast carcinoma in situ
stage I breast cancer
stage II breast cancer
breast cancer in situ

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 15 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of California, Davis is the lead sponsor of 798 studies on the registry; 146 are open to participants now.

Of its 65 completed or terminated interventional studies of FDA-regulated products, 43 (66%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: 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

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (actual)

Study arms

Experimental
RFA prior to surgery
Procedure: conventional surgery · Procedure: neoadjuvant therapy · Procedure: radiofrequency ablation

Interventions

Procedureconventional surgery
Standard of care lumpectomy or mastectomy following RFA
Procedureneoadjuvant therapy
Standard of care lumpectomy or mastectomy following RFA
Procedureradiofrequency 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.
Also known as: RFA

What researchers measure

Primary outcomes

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 outcomes

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

Study locations

1 site

University of California Davis Cancer Center
Sacramento, California 95817, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 29, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00388115
Lead sponsor: University of California, Davis
Collaborators: National Cancer Institute (NCI)
First posted: Oct 13, 2006
Start date: Oct 2001
Primary completion: May 2007
Completion: May 2007
Last update: Mar 29, 2010

Study contacts

Vijay Khatri, MD

principal investigator · University of California, Davis

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

University of California, Davis

Start the discussion