Percutaneous Removal and Margin Ablation for Breast Cancer

Breast Cancer Clinical Trial

Official title:

Percutaneous Removal and Margin Ablation for Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574301
• Other study ID #: UAMS 07050
• Secondary ID: NIH Grant 5 R21
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 14, 2007
• Last updated: July 24, 2013
• Start date: March 2002
• Est. completion date: October 2011

Study information

• Verified date: July 2013
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

We hypothesize that radiofrequency ablation after single-insertion image guided vacuum assisted biopsy (IVEB) can be used to achieve negative margins in small unicentric breast cancers (≤1.5 cm).

Description:

Using the Mammotome Breast Biopsy System (IVEB) in conjunction with MRI to predict extent of disease, ultrasound to direct removal of the tumor, touch preparation cytology for diagnosis, and ablation of margins using radiofrequency ablation (RFA), we propose to develop a comprehensive system for same-day diagnosis and treatment of patients with small breast lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 2011
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Female, 18 to 90 years of age

• Non-pregnant, not breastfeeding

• Pre-study documentation of:

• Size =1.5 cm cancer successfully removed by US-guided IVEB within 30 days of registration

• Uni-centricity, unilateral cancer by radiology (mammogram and MRI)

• Location of abnormality > 1 cm from the skin

• Ductal Carcinoma, Invasive (Grade I-III) or In-Situ

• No palpable axillary or supraclavicular lymph nodes

• Good general health

• Zubrod Performance Status of 0, 1, or 2

• If prior non-breast malignancy, must have 5 year disease-free survival

• No prior chemotherapy

• Hormonal therapy must be stopped

• Therapy with tamoxifen must have been of 14 days or less duration

Exclusion Criteria:

• Subjects less than 18 years of age or greater than 90 years of age

• Pregnant or breastfeeding

• Male

• Prior Breast Biopsy affected breast

• Breast implants

• Multicentric disease, bilateral disease

• Residual disease after IVEB of > 1cm on MRI

• Lesions > 1.5 cm in diameter

• Lesions < 1 cm from skin surface

• Previous radiation therapy to the breast

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Percutaneous Removal and Margin Ablation
Patients with a diagnosis of unicentric invasive breast cancer diagnosed by IVEB will then be assigned to the next available surgery date. On that day, the patient's axillary staging will be done, followed by ablation of the biopsy cavity using RFA. The breast surgery may include lumpectomy (which will be directed with US-guidance to assure more accurate removal of the en bloc IVEB site and the margin zone of ablation) or simple mastectomy with or without reconstruction. The tissue specimen will be sent immediately from the operating room to Pathology for routine processing.

Locations

Country	Name	City	State
United States	University of Arkansas For Medical Sciences	Little Rock	Arkansas

Sponsors (4)

Lead Sponsor	Collaborator
University of Arkansas	Department of Health and Human Services, Ethicon Endo-Surgery, RITA Medical Systems

Country where clinical trial is conducted

United States, 

References & Publications (2)

Johnson AT, Henry-Tillman RS, Smith LF, Harshfield D, Korourian S, Brown H, Lane S, Colvert M, Klimberg VS. Percutaneous excisional breast biopsy. Am J Surg. 2002 Dec;184(6):550-4; discussion 554. — View Citation

Klimberg VS, Boneti C, Adkins LL, Smith M, Siegel E, Zharov V, Ferguson S, Henry-Tillman R, Badgwell B, Korourian S. Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol. 2011 Oct;18(11):3079-87. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation		Post-surgical pathology review	No
Secondary	The proportion of patients with viable tumor cells beyond the margin		Post-surgical pathology review	No