Clinical trial NCT02340858: Percutaneous Irreversible Electroportion for Unresectable Breast Cancer
Official title: Safety and Efficacy of Irreversible Electroporation (IRE) for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Fuda Cancer Hospital, Guangzhou
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a phase I/II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. The primary and secondary objectives of the study are described below.

OBJECTIVES

Primary

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

secondary

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

To describe the adverse events associated with IRE To prospectively gather pain assessment data on cryoablation and surgical resection Explore technical variables that may affect the success of IRE

Eligibility criteria: Inclusion Criteria:

1. Women 18 years or older with unresectable breast cancer, not amenable/willing to adenomammectomy.
2. breast carcinoma diagnosed by core needle biopsy.
3. Any menopausal status.
4. No history of en bloc open surgical biopsy and/or lumpectomy for diagnostic/treatment of the index breast cancer.
5. Tumor size ≤ 5.0 cm in greatest diameter. Largest size measured by required scans (mammogram, ultrasound and MRI) will be used to determine eligibility.
6. Tumor enhancement on pre-study MRI.
7. Tumor with \< 25% intraductal components in the aggregate.
8. Progressed within 12 months from prior adjuvant or progressed within 1 month from prior advanced/metastatic endocrine breast cancer therapy,
9. Non-pregnant and non-lactating. Patients of childbearing potential must have a negative serum or urine pregnancy test.
10. 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.
11. Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
12. Patient must agree to provide tumor tissue from metastatic tissue at baseline.

Exclusion Criteria:

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

Primary outcomes:
measure: Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging.
timeFrame: 3 months post treatment to 24 months
Secondary outcomes:
measure: Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria.
timeFrame: 1 day post treatment to 3 weeks
Other outcomes:
measure: Adverse Events
timeFrame: 1 day post surgery to 3 weeks
Locations:
city: Guangzhou
country: China
facility: FUDA Cancer Hospital
state: Guangdong
Study officials:
affiliation: FUDA Cancer Hospital
name: Lizhi l Niu
role: STUDY_DIRECTOR
References: