Excision Followed by Radiofrequency Ablation for Breast Cancer
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Between 50 Years and 100 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Surgery followed by RFA |
|
Recruiting Locations
More Details
- NCT ID
- NCT01153035
- Status
- Active, not recruiting
- Sponsor
- University of Arkansas