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 range
18 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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