NCT02340858

Brief Summary

This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore on the cell membrane and inducing target cell death.This may be an effective treatment for patients with unresectable breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 5, 2021

Status Verified

May 1, 2019

Enrollment Period

5.9 years

First QC Date

January 12, 2015

Last Update Submit

September 1, 2021

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.

    3 months post treatment to 24 months

Secondary Outcomes (1)

  • Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.

    1 day post treatment to 3 weeks

Other Outcomes (1)

  • Adverse Events

    1 day post surgery to 3 weeks

Study Arms (2)

NanoKnife LEDC System

EXPERIMENTAL

90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Device: NanoKnife LEDC System

Control

NO INTERVENTION

The patients without treatment

Interventions

NanoKnife LEDC SystemDEVICE

Irreversible electroporation (IRE) is a method to induce irreversible disruption of cell membrane integrity (loss of cell homeostasis) resulting in cell death without the need for additional pharmacological injury. Because IRE is a non-thermal technique, changes associated with perfusion-mediated tissue cooling (or heating) are not relevant. While cells in the ablation region are destroyed, the underlying extracellular matrix is not damaged thus allowing tissues in the ablation zone to heal normally.

Also known as: NanoKnife
NanoKnife LEDC System

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy.
  • breast carcinoma diagnosed by core needle biopsy.
  • Any menopausal status.
  • No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer.
  • Tumor size ≤ 5.0 cm in greatest diameter. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
  • Tumor enhancement on pre-study MRI.
  • Tumor with \< 25% intraductal components in the aggregate.
  • Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy,
  • Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test.
  • Adequate breast size for safe IRE. Male breast cancer patients and female breast cancer patients with breasts too small to allow safe IRE are not eligible as the minimal thickness of the breast tissue does not lend itself to IRE. NOTE: For patients with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion will not contact or jeopardize the implant.
  • Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
  • Patient must agree to provide tumor tissue from metastatic tissue at baseline.

You may not qualify if:

  • Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS.
  • History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
  • Prior or planned neoadjuvant chemotherapy for breast cancer.
  • Patients with thrombocytopenia and or any other coagulation abnormality

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FUDA Cancer Hospital

Guangzhou, Guangdong, 510665, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lizhi l Niu

    FUDA Cancer Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 19, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2020

Study Completion

January 1, 2021

Last Updated

September 5, 2021

Record last verified: 2019-05

Locations

CN(1)