Radiofrequency Ablation After Breast Lumpectomy (ABLATE)
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 3/30/2013 |
| Start Date: | April 2011 |
| End Date: | July 2016 |
| Contact: | Marilee K McGinness, MD, FACS |
| Email: | mmcginness@kumc.edu |
| Phone: | 913-588-5166 |
ABLATE Trial: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
The main purpose of the study is to study the effectiveness of using a technique called
RadioFrequency Ablation (RFA) after the breast tumor has been surgically removed. Ablation
means cells are destroyed. The RFA device creates heat that destroys any cells in the area
around where the tumor is removed, an area called the cavity or tumor bed
This study will evaluate 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 and potentially obviate the need for XRT in early breast cancer. 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-II
- 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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