Excision Followed by Radiofrequency Ablation for Breast Cancer
NCT ID: NCT01153035
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
104 participants
INTERVENTIONAL
2010-06-30
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Surgery followed by RFA
Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Interventions
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Radiofrequency Ablation
Breast conservation surgery followed by Radiofrequency Ablation of the cavity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
50 Years
100 Years
FEMALE
No
Sponsors
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Angiodynamics, Inc.
INDUSTRY
University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Daniela Ochoa, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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University of Arizona
Tucson, Arizona, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Sharp Oncology (Comprehensive Breast Care of San Diego)
San Diego, California, United States
Comprehensive Breast Care of Denver
Denver, Colorado, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Columbia
New York, New York, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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NCT01420380
Identifier Type: -
Identifier Source: nct_alias
104603
Identifier Type: -
Identifier Source: org_study_id