Excision Followed by Radiofrequency Ablation for Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study will be to evaluate, in a multi-center setting, the ability of radiofrequency ablation (RFA) of breast cancer lumpectomy sites to extend the final negative margin and consequently decrease the rates of re-operation. During the initial breast conservation procedure (lumpectomy), immediately following routine surgical resection of the tumor, radiofrequency energy (RFA) is applied to the wall (bed) of the fresh lumpectomy cavity, thus extending tumor free margin radially beyond the volume of the resected specimen.

Official Title
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ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Radiofrequency Ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is a female, ≥ 50 years of age The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam) The tumor is unicentric and unilateral The tumor is not involving the skin Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+) Patient signs current written informed consent and HIPAA forms Exclusion Criteria: Patient is under 50 years of age Patient is male Tumor > 3 cm in diameter Bilateral malignancy Clinically positive lymph nodes Tumor involving the skin Pathology confirms invasive lobular carcinoma Breast implants Less than 2 years disease-free survival from previous breast cancer Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgery followed by RFA<br> | Device: Radiofrequency Ablation<br>* Breast conservation surgery followed by Radiofrequency Ablation of the cavity<br>* Other names: AngioDynamics, Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimate the re-excision rate for close (<3mm) or positive margins | How many patients must go back for re-excision of margins | Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed) | 
| Decrease local recurrence | The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences. | Monitor throughout 5 year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Conservation Therapy, Lumpectomy, Radiofrequency Ablation, Radiation