Percutaneous Removal and Margin Ablation for Breast Cancer

University of Arkansas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Percutaneous Removal and Margin Ablation

Study type: Interventional

Funder types: Other; Other U.S. Federal agency; Industry

Identifiers

NCT00574301

UAMS 07050

NIH Grant 5 R21 CA097715-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 32 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

1

Experimental group

Treatment:

Procedure: Percutaneous Removal and Margin Ablation