Excision Followed by Radiofrequency Ablation for Breast Cancer

NCT01153035 | Active Not Recruiting

• 1 other identifier: 104603
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Conservation Therapy; Lumpectomy; Radiofrequency Ablation; Radiation

Outcome Measures

Primary Outcomes (2)

• Estimate the re-excision rate for close (<3mm) or positive margins

  How many patients must go back for re-excision of margins

  Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)

• Decrease local recurrence

  The patient will be followed closely from the time of surgery through a period of 5 years in order to assess the frequency of local recurrence, defined as a new diagnosis of cancer at or near the site of primary surgery. It is our thought that the addition of RFA to the standard surgical treatment will reduce the number of local recurrences.

  Monitor throughout 5 year follow-up

Study Arms (1)

Surgery followed by RFA

OTHER

Device: Radiofrequency Ablation

Interventions

Radiofrequency Ablation DEVICE

Breast conservation surgery followed by Radiofrequency Ablation of the cavity

Also known as: AngioDynamics, Inc.

Surgery followed by RFA

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Arkansas: lead
• Angiodynamics, Inc.: collaborator

Study Sites (6)

University of Arizona

Tucson, Arizona, 85704, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Sharp Oncology (Comprehensive Breast Care of San Diego)

San Diego, California, 92123, United States

Location

Comprehensive Breast Care of Denver

Denver, Colorado, 80218, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Columbia

New York, New York, 10032, United States

Location

Related Publications (3)

• Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11.

  PMID: 24655863 BACKGROUND

• Mackey A, Feldman S, Vaz A, Durrant L, Seaton C, Klimberg VS. Radiofrequency ablation after breast lumpectomy added to extend intraoperative margins in the treatment of breast cancer (ABLATE): a single-institution experience. Ann Surg Oncol. 2012 Aug;19(8):2618-9. doi: 10.1245/s10434-012-2293-7. Epub 2012 Mar 16.

  PMID: 22422482 RESULT

• Wilson M, Korourian S, Boneti C, Adkins L, Badgwell B, Lee J, Suzanne Klimberg V. Long-term results of excision followed by radiofrequency ablation as the sole means of local therapy for breast cancer. Ann Surg Oncol. 2012 Oct;19(10):3192-8. doi: 10.1245/s10434-012-2476-2. Epub 2012 Aug 22.

  PMID: 22911363 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Daniela Ochoa, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (6)