Clinical trial · Interventional
Excision Followed by Radiofrequency Ablation for Breast Cancer
ABLATE Registry: Radiofrequency Ablation After Breast Lumpectomy (eRFA) Added To Extend Intraoperative Margins in the Treatment of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiofrequency Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Surgery followed by RFA
- interventionNames
- Device: Radiofrequency Ablation
Primary outcomes (2)
- 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)
- description
- How many patients must go back for re-excision of margins
- measure
- Decrease local recurrence
- timeFrame
- Monitor throughout 5 year follow-up
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDKlimberg 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
- RESULTMackey 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
- RESULTWilson 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. PMID 22911363