NCT00388115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2001

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2006

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

March 29, 2010

Status Verified

March 1, 2010

Enrollment Period

5.6 years

First QC Date

October 12, 2006

Last Update Submit

March 25, 2010

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situstage I breast cancerstage II breast cancerbreast cancer in situ

Outcome Measures

Primary Outcomes (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

    At completion of study

Secondary Outcomes (3)

  • 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

Study Arms (1)

RFA prior to surgery

EXPERIMENTAL
Procedure: conventional surgeryProcedure: neoadjuvant therapyProcedure: radiofrequency ablation

Interventions

conventional surgeryPROCEDURE

Standard of care lumpectomy or mastectomy following RFA

RFA prior to surgery
neoadjuvant therapyPROCEDURE

Standard of care lumpectomy or mastectomy following RFA

RFA prior to surgery
radiofrequency ablationPROCEDURE

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
RFA prior to surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Cancer Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, NoninfiltratingBreast Carcinoma In Situ

Interventions

Neoadjuvant TherapyRadiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsRadiofrequency TherapyAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Vijay Khatri, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2006

First Posted

October 13, 2006

Study Start

October 1, 2001

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

March 29, 2010

Record last verified: 2010-03

Locations

US(1)