Percutaneous Removal and Margin Ablation for Breast Cancer

NCT ID: NCT00574301

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2011-10-31

Brief 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).

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Percutaneous Removal and Margin Ablation

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Mammotome Breast Biopsy System (IVEB), Ethicon Endo-Surgery; Radiofrequency Ablation (RFA), RITA Medical Systems; Lumpectomy; Mastectomy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: collaborator

RITA Medical Systems

INDUSTRY

Sponsor Role: collaborator

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

V. Suzanne Klimberg, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

References

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. doi: 10.1016/s0002-9610(02)01099-1.

Reference Type: BACKGROUND

PMID: 12488164 (View on PubMed)

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: 10.1245/s10434-011-2002-y. Epub 2011 Sep 9.

Reference Type: RESULT

PMID: 21904959 (View on PubMed)

Other Identifiers

NIH Grant 5 R21 CA097715-01

Identifier Type: -

Identifier Source: secondary_id

UAMS 07050

Identifier Type: -

Identifier Source: org_study_id