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


N/A
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Estimate the re-excision rate for close (<2mm) or positive margins and decrease recurrence and obviate need for XRT in early breast cancer

Outcome Description:

In this study, we will review the number of patients that will go back for re-excision of margins. The patient will be monitored through a period of 5 years to assess the frequency of local recurrence. It is anticipated that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.

Outcome Time Frame:

2 weeks after surgery to allow for pathology report

Safety Issue:

No

Principal Investigator

Marilee K McGinness, MD, FACS

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

12347

NCT ID:

NCT01420380

Start Date:

April 2011

Completion Date:

July 2016

Related Keywords:

  • Breast Cancer
  • breast cancer
  • breast neoplasms
  • breast diseases
  • Breast Neoplasms

Name

Location
University of Kansas Medical Center Kansas City, Kansas  66160-7353