Excision Followed by Radiofrequency Ablation for Breast Cancer

Running, not enrolling · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01153035

Run by

University of Arkansas

People needed

104

Starts

2010-06-01

Expected to finish

2027-06-01

Last updated by the study team

2025-11-10

Who can join

Age: 50 and older, up to 100. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Sharp Oncology (Comprehensive Breast Care of San Diego) — San Diego, California, United States
• Comprehensive Breast Care of Denver — Denver, Colorado, United States
• The University of Kansas Cancer Center — Westwood, Kansas, United States
• Columbia — New York, New York, United States

Full record on ClinicalTrials.gov

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