Clinical trial NCT01153035: Excision Followed by Radiofrequency Ablation for Breast Cancer
Official title: ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added to Extend Intraoperative Margins in the Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Conservation Therapy
Lumpectomy
Radiofrequency Ablation
Radiation
Lead sponsor: University of Arkansas
Sponsor class: OTHER
Collaborators: name: Angiodynamics, Inc.
First posted: 2010-06-29
Enrollment: 104
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Estimate the re-excision rate for close (<3mm) or positive margins
timeFrame: Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)
measure: Decrease local recurrence
timeFrame: Monitor throughout 5 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: San Diego
country: United States
facility: Sharp Oncology (Comprehensive Breast Care of San Diego)
state: California
city: Denver
country: United States
facility: Comprehensive Breast Care of Denver
state: Colorado
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: New York
country: United States
facility: Columbia
state: New York
Study officials:
affiliation: University of Arkansas
name: Daniela Ochoa, MD
role: PRINCIPAL_INVESTIGATOR
References:
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: 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.
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.