Safety and Feasibility of IRE for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study

Official title

Safety and Feasibility of Irreversible Electroporation for Early-stage Breast Cancer: a Prospective, Open-Label, Single-Arm, Exploratory Study

Overview

This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer.

Detailed description

This is a prospective, open-label, single-arm, exploratory clinical trial conducted at our institution to investigate the use of Irreversible Electroporation (IRE) for the treatment of breast cancer. Qualified patients will receive IRE ablation, followed by standard surgical resection. The efficacy and feasibility of IRE will be evaluated through statistical analysis of the outcomes, which will be recorded in accordance with the primary and secondary efficacy endpoints.

Interventions

• Device IRE by stunning pulse therapy device
  Qualified patients will receive IRE ablation, followed by standard surgical resection for breast cancer.During the process, patients will be followed up and evaluated

Primary outcome measures

• Complete ablation rate [Time frame: 1 month]
• Technical success rate [Time frame: 1 month]

Secondary outcome measures (3)

• Incidence of Treatment-Emergent Adverse Events [Time frame: 1 month]
• Pain scores [Time frame: 1 month]
• Imaging analysis [Time frame: 1 month]

Eligibility criteria

Inclusion criteria

• Female, aged 18 years or older.
• Medically fit for both surgery and general anesthesia, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Treatment-naïve, primary, unifocal breast cancer with a maximum diameter of ≤ 2.0 cm as assessed by MRI.
• Pathologically confirmed diagnosis of Invasive Ductal Carcinoma (IDC) within 3 months prior to enrollment.
• Tumor that presents as a well-defined, localized mass and is clearly visualized on both breast ultrasound (for intraoperative guidance) and breast DCE-MRI (for baseline measurement and treatment planning).
• The subject must be able to understand the purpose of the trial, voluntarily participate, and provide written informed consent.

Exclusion criteria

• Known coagulopathy or bleeding diathesis (defined as a platelet count < 50×10⁹/L or an International Normalized Ratio (INR) > 1.5).
• Presence of an implanted cardiac pacemaker, defibrillator, or any other active electronic medical device.
• History of significant cardiac disease, including but not limited to: uncontrolled cardiac arrhythmias or congestive heart failure classified as New York Heart Association (NYHA) Class III or IV.
• Patients who are pregnant, lactating, or planning a pregnancy during the study period.
• Known severe allergy or anaphylactic reaction to MRI contrast agents.
• Known high-risk genetic susceptibility to breast cancer (e.g., BRCA1/2 mutation carrier) associated with an increased risk of ipsilateral breast tumor recurrence following ablation.
• Presence of distant metastases.
• Any other medical or psychiatric condition that, in the investigator's judgment, would compromise the patient's safety or compliance with the study protocol.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 2 centers

• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Publications

• Zhang K, Teoh J, Laguna P, Dominguez-Escrig J, Barret E, Ramon-Borja JC, Muir G, Bohr J, de Reijke TM, Pelechano Gomez P, Ng CF, Sanchez-Salas R, de la Rosette J. Effect of Focal vs Extended Irreversible Electroporation for the Ablation of Localized Low- or Intermediate-Risk Prostate Cancer on Early Oncological Control: A Randomized Clinical Trial. JAMA Surg. 2023 Apr 1;158(4):343-349. doi: 10.100 PMID 36723911
• Li S, Chen F, Shen L, Zeng Q, Wu P. Percutaneous irreversible electroporation for breast tissue and breast cancer: safety, feasibility, skin effects and radiologic-pathologic correlation in an animal study. J Transl Med. 2016 Aug 5;14(1):238. doi: 10.1186/s12967-016-0993-7. PMID 27495906
• Neal RE 2nd, Singh R, Hatcher HC, Kock ND, Torti SV, Davalos RV. Treatment of breast cancer through the application of irreversible electroporation using a novel minimally invasive single needle electrode. Breast Cancer Res Treat. 2010 Aug;123(1):295-301. doi: 10.1007/s10549-010-0803-5. Epub 2010 Feb 27. PMID 20191380
• Neal RE 2nd, Davalos RV. The feasibility of irreversible electroporation for the treatment of breast cancer and other heterogeneous systems. Ann Biomed Eng. 2009 Dec;37(12):2615-25. doi: 10.1007/s10439-009-9796-9. Epub 2009 Sep 15. PMID 19757056
• Collettini F, Enders J, Stephan C, Fischer T, Baur ADJ, Penzkofer T, Busch J, Hamm B, Gebauer B. Image-guided Irreversible Electroporation of Localized Prostate Cancer: Functional and Oncologic Outcomes. Radiology. 2019 Jul;292(1):250-257. doi: 10.1148/radiol.2019181987. Epub 2019 Jun 4. PMID 31161973
• Wang H, Xue W, Yan W, Yin L, Dong B, He B, Yu Y, Shi W, Zhou Z, Lin H, Zhou Y, Wang Y, Shi Z, Ren S, Gao X, Wang L, Xu C. Extended Focal Ablation of Localized Prostate Cancer With High-Frequency Irreversible Electroporation: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Aug 1;157(8):693-700. doi: 10.1001/jamasurg.2022.2230. PMID 35793110
• Ruarus AH, Vroomen LGPH, Geboers B, van Veldhuisen E, Puijk RS, Nieuwenhuizen S, Besselink MG, Zonderhuis BM, Kazemier G, de Gruijl TD, van Lienden KP, de Vries JJJ, Scheffer HJ, Meijerink MR. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology. 2020 Jan;294(1):212-220. doi: 10. PMID 31687922
• Al Efishat M, Wolfgang CL, Weiss MJ. Stage III pancreatic cancer and the role of irreversible electroporation. BMJ. 2015 Mar 18;350:h521. doi: 10.1136/bmj.h521. PMID 25787829

Identifiers

NCT: NCT07263451 · IREBreast

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗