Clinical trial NCT00571987: Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
Official title: Pilot Study of Radiofrequency Ablation of Breast Cancer Lumpectomy Sites to Decrease Re-operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cancer of the Breast
Keywords: Breast cancer
Lumpectomy
Radiofrequency Ablation
Negative margins
Breast Conserving Surgery
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Angiodynamics, Inc.
First posted: 2007-12-12
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: While RFA alone is not approved for tumor destruction in breast it is FDA-approved for ablation of soft tissue after the breast cancer is removed. This study seeks to remove the tumor and then ablate a tumor-free zone (margin) of tissue around the lumpectomy site instead of removing more tissue. The primary short-term goal is to obviate the need for re-excision in the event of close or positive margins (\< 3 mm) which occurs on average in \~40 percent of the cases. Permanent pathology is only an estimation of margin status since 90% of recurrences occur at the site of the original lumpectomy. RFA ensures a sterilized margin regardless of the accuracy of the permanent pathology.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Number of Patients Requiring 2nd Surgery for Close or Positive Margins
timeFrame: Margins assessed at Final Pathology, approximately 1 week post-RF surgery
Secondary outcomes:
measure: Recurrence of Breast Cancer at Prior Site of Disease
timeFrame: Until study end (2 years)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas For Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: V. Suzanne Klimberg, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.