Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation

NCT00571987 | Completed Phase 1 Results

• 1 other identifier: UAMS 29143
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

In this protocol we combine two available and reliable treatments - lumpectomy and RFA. This combination method will provide for excision of the cancer as routinely accomplished and ablation of the cancer bed (lumpectomy site) to ensure negative margins without removing large volumes of tissue. This combined open technique will allow for full histologic analysis of the primary tumor and margin. Because no extra tissue is removed from the breast to generate negative margins it will result in better cosmesis than re-excision to obtain negative margins.

Conditions

Cancer of the Breast

Keywords

Breast cancer; Lumpectomy; Radiofrequency Ablation; Negative margins; Breast Conserving Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Patients Requiring 2nd Surgery for Close or Positive Margins

  A "close" surgical margin implies that cancer cells are found on pathology to be very close to the surgical margin, and a "wide" surgical margin implies the tumor exists far from the cut edge or the surgical margin. For this study, we defined "close" as less than 3 mm.

  Margins assessed at Final Pathology, approximately 1 week post-RF surgery

Secondary Outcomes (1)

• Recurrence of Breast Cancer at Prior Site of Disease

  Until study end (2 years)

Study Arms (1)

1

OTHER

This is a non-randomized one arm study, all subjects receive treatment (radiofrequency ablation).

Device: AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe)

Interventions

AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe) DEVICE

Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.

1

Eligibility Criteria

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

You may qualify if:

• Female, 18-100 years old
• Not pregnant or breastfeeding
• Pre-study radiologic documentation of:
• size ≤ 5 cm
• unicentric, unilateral
• suspicious mass or calcification
• BIRADS classification ≥ IV
• location of abnormality \> 1 cm from skin
• Ductal or Infiltrating Ductal Carcinoma
• Grade I-III on final pathology
• Good general health
• Zubrod Performance Status of 0,1, or 2
• No previous chemotherapy
• No palpable axillary or supraclavicular lymph nodes
• If prior non-breast malignancy, must have \> 5 year disease-free survival

You may not qualify if:

• Patient \< 18 y/o or \> 100 y/o
• Pregnant or breastfeeding
• Male
• Breast implants
• Multicentric disease or bilateral disease
• Lesions \> 5 cm in diameter
• Lesions \< 1.0 cm from the skin
• Previous prior radiation to the breast
• Need for mastectomy
• Diffuse microcalcifications (as determined by the Investigator)

Sponsors & Collaborators

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

Study Sites (1)

University of Arkansas For Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Related Publications (4)

• Klimberg VS, Kepple J, Shafirstein G, Adkins L, Henry-Tillman R, Youssef E, Brito J, Talley L, Korourian S. eRFA: excision followed by RFA-a new technique to improve local control in breast cancer. Ann Surg Oncol. 2006 Nov;13(11):1422-33. doi: 10.1245/s10434-006-9151-4. Epub 2006 Sep 29.

  PMID: 17009144 BACKGROUND

• Klimberg VS, Boneti C, Adkins LL, Smith M, Siegel E, Zharov V, Ferguson S, Henry-Tillman R, Badgwell B, Korourian S. Feasibility of percutaneous excision followed by ablation for local control in breast cancer. Ann Surg Oncol. 2011 Oct;18(11):3079-87. doi: 10.1245/s10434-011-2002-y. Epub 2011 Sep 9.

  PMID: 21904959 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 BACKGROUND

• 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

Related Links

• Long-Term Results of Phase II Ablation after Breast Lumpectomy Added to Extend Intraoperative Margins (ABLATE l) Trial Presented at the Southern Surgical Association 125th Annual Meeting, Hot Springs, VA, December 2013.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Suzanne Klimberg
• Organization: UAMS

klimbergsuzanne@uams.edu

501-686-6504

Study Officials

• V. Suzanne Klimberg, M.D.

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: September 1, 2004
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 24, 2015
• Results First Posted: October 6, 2015

Record last verified: 2015-10

Locations

US (1)