Percutaneous Removal and Margin Ablation for Breast Cancer (NCT00574301) | Clinical Trial Compass
CompletedPhase 1/2
Percutaneous Removal and Margin Ablation for Breast Cancer
United States32 participantsStarted 2002-03
Plain-language 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).
Who can participate
Age range18 Years – 90 Years
SexFEMALE
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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
What they're measuring
1
To quantify the degree of tumor-free margin achieved with image-guided vacuum assisted biopsy followed by ablation with radiofrequency ablation