Breast Cancer Clinical Trial
Excision Followed by Radiofrequency Ablation for Breast Cancer
Summary
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.
Eligibility Criteria
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
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There are 6 Locations for this study
Tucson Arizona, 85704, United States
Little Rock Arkansas, 72205, United States
San Diego California, 92123, United States
Denver Colorado, 80218, United States
Westwood Kansas, 66205, United States
New York New York, 10032, United States
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