Radiofrequency Ablation Followed By Surgery in Treating Patients With Early Invasive Breast Cancer or Ductal Carcinoma in Situ - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00388115

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study of Radiofrequency Ablation of Early Invasive and In Situ Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Number and proportion of patients with viable cancer cells remaining in the resected specimen as measured by enzyme cell viability analysis at post-treatment biopsy [ Designated as safety issue: No ]
Amount of tumor coagulated [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number and proportion of patients with uncoagulated tumor remnant at post-treatment biopsy [ Designated as safety issue: No ]
Number and proportion of patients with and without tumor in the margin [ Designated as safety issue: No ]
Rate of acute skin toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	October 2001

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

DISEASE CHARACTERISTICS:

Histologically confirmed early invasive breast cancer or low- or intermediate-grade ductal carcinoma in situ (DCIS)
- Tumor measures ≤ 2.0 cm in diameter
- Multifocal invasive breast cancer allowed
  - Tumors must be palpable or visualized by ultrasound scan
- No evidence of diffuse calcification suggestive of extensive or multifocal DCIS
- No high-grade DCIS or presence of comedo-necrosis
Disease confirmed by stereotactic- or ultrasound-guided core biopsy for mammographic lesions and by needle core biopsy for clinically palpable lesions
No evidence of distant metastatic disease
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
ECOG performance status 0-2
Life expectancy > 10 years (not including diagnosis of breast cancer)

PRIOR CONCURRENT THERAPY:

At least 30 days since prior surgical treatment for breast cancer

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

Investigators

Investigator:

Corinne Turrell, CCRP

University of California, Davis

More Information

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

Study ID Numbers:	CDR0000505536, UCD-123, UCD-200210277-6
Study First Received:	October 12, 2006
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00388115
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Carcinoma, Ductal
Skin Diseases
Carcinoma in Situ
Breast Neoplasms
Carcinoma, Ductal, Breast

Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary

ClinicalTrials.gov processed this record on January 30, 2009