Excision Followed by Radiofrequency Ablation for Breast Cancer (ABLATE)
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Ablation
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Conservation Therapy, Lumpectomy, Radiofrequency Ablation, Radiation
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
Sites / Locations
- University of Arizona
- University of Arkansas for Medical Sciences
- Sharp Oncology (Comprehensive Breast Care of San Diego)
- Comprehensive Breast Care of Denver
- The University of Kansas Cancer Center
- Columbia
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Surgery followed by RFA
Arm Description
Outcomes
Primary Outcome Measures
Estimate the re-excision rate for close (<3mm) or positive margins
How many patients must go back for re-excision of margins
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01153035
First Posted
June 24, 2010
Last Updated
February 9, 2023
Sponsor
University of Arkansas
Collaborators
Angiodynamics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01153035
Brief Title
Excision Followed by Radiofrequency Ablation for Breast Cancer
Acronym
ABLATE
Official Title
ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2010 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas
Collaborators
Angiodynamics, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Conservation Therapy, Lumpectomy, Radiofrequency Ablation, Radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surgery followed by RFA
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Radiofrequency Ablation
Other Intervention Name(s)
AngioDynamics, Inc.
Intervention Description
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Primary Outcome Measure Information:
Title
Estimate the re-excision rate for close (<3mm) or positive margins
Description
How many patients must go back for re-excision of margins
Time Frame
Post-surgery (defined as 2 weeks after surgery, to allow time for pathology to be completed)
Title
Decrease local recurrence
Description
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.
Time Frame
Monitor throughout 5 year follow-up
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ochoa, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Sharp Oncology (Comprehensive Breast Care of San Diego)
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Comprehensive Breast Care of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Columbia
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24655863
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.
Results Reference
background
PubMed Identifier
22422482
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.
Results Reference
result
PubMed Identifier
22911363
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.
Results Reference
result
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Excision Followed by Radiofrequency Ablation for Breast Cancer
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