Percutaneous Removal and Margin Ablation for Breast Cancer

University of Arkansas32 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Percutaneous Removal and Margin AblationPROCEDURE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation

Time frame: Post-surgical pathology review

Secondary Outcomes

The proportion of patients with viable tumor cells beyond the margin

Time frame: Post-surgical pathology review

Data from ClinicalTrials.gov

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