Excision Followed by Radiofrequency Ablation for Breast Cancer

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	50 - 100
Updated:	7/1/2018
Start Date:	June 2010
End Date:	June 2020

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

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.

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

We found this trial at

sites

University of Arkansas for Medical Sciences

529 West Markham Street
Little Rock, Arkansas 72205

(501) 686-7000