This is a phase I trial of the safety of image-guided pulsed electric field (PEF) ablation for the locoregional treatment of superficial soft tissue lesions in adults with metastatic breast cancer using the AliyaTM Pulsed Electric Field System.
PRIMARY OBJECTIVE: I. To assess the safety of PEF for locoregional treatment of soft tissue metastatic breast cancer lesions. SECONDARY OBJECTIVE: I. To assess the effect of PEF on patient-reported symptoms and quality of life. II. To assess the feasibility of performing PEF for superficial soft tissue metastases. EXPLORATORY OBJECTIVE: I. To explore blood-based biomarker responses to PEF. II. To explore the efficacy of PEF in treating locoregional disease, as well as its effect on untreated lesions. OUTLINE: Participants will receive a single treatment of PEF ablation delivered to up to 3 soft metastatic breast cancer lesion(s). After the treatment, participants are followed at Day 0, week 2, week 4, and up to 1 year post ablation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Pulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors
Participants will complete health related, quality of life questionnaires
Undergo ablation via PEF
University of California San Francisco
San Francisco, California, United States
RECRUITINGProportion of participants with treatment-emergent adverse events
Proportion of participants who experience adverse event from the Pulsed Electric Field (PEF) ablation treatment. Standard deviation and 95% confidence intervals will be reported.
Time frame: Up to 4 weeks
Mean change of score on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR-23)
EORTC QLQ-BR23 incorporates five multi-item scales to assess body image, sexual functioning, systemic therapy side effects, breast symptoms, and arm symptoms. In addition, single items assess sexual enjoyment, future perspective and being upset by hair loss. All of the scales and single-item measures range in score from 0 to 100. The mean and standard deviation of the change in EORTC QLQ-BR23 scores, along with the 95% confidence interval, will be reported.
Time frame: Up to 4 weeks
Mean change of score on EuroQol five-dimensional Questionnaire (EQ-5D)
EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. The mean and standard deviation of the change in EQ-5D scores, along with the 95% confidence interval, will be reported.
Time frame: Up to 4 weeks
Mean technical success rate of Pulsed Electric Field (PEF) ablation
Immediately after PEF ablation, the technical success rate and any procedural technical challenges will be recorded. Mean, standard deviation of technical success rate for PEF ablation and 95% confidence will be reported.
Time frame: Up to 1 day
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