Breast Cancer, Metastatic Breast Cancer
Conditions
Keywords
Image Guided Ablation, Tumor Ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEPulsed Electric Field (PEF) System
Pulsed electric field (PEF) delivers short, high frequency electrical pulses that are intended to shrink or destroy tumors
BEHAVIORALQuestionnaires
Participants will complete health related, quality of life questionnaires
PROCEDURETumor Ablation
Undergo ablation via PEF
Sponsors
University of California, San Francisco
Galvanize Therapeutics, Inc.
Society of Interventional Radiology Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants must have histologically or cytologically confirmed metastatic breast cancer. 2. Confirmed documented soft tissue involvement via imaging or biopsy, with at least one measurable lesion with a cutaneous and/or subcutaneous component that is at least 1 cm in size but no greater than 5 cm in size and that can be safely accessed under image guidance. Up to 3 lesions that meet these criteria may be treated with PEF ablation therapy. 3. There are no limits on the amount of prior or concurrent anti-cancer therapies, but patients must be medically able (in the opinion of referring provider and treating investigator) to withhold their systemic therapy for breast cancer one week before the PEF ablation and for 2 weeks after the procedure. 4. Age ≥18 years 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6. Adequate Bone Marrow Function: 1. Absolute neutrophil count ≥1,500/microliter (mcL). 2. Platelets ≥100,000/mcL. 7. Not on or able to withhold anticoagulation or antiplatelet therapy per Society of Interventional Radiology periprocedural guideline. 8. Human immunodeficiency virus (HIV)-infected individuals on effective anti-retroviral therapy with undetectable viral load within 6 months (as documented in the medical record) are eligible for this trial. 9. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy (as documented in the medical record), if indicated. 10. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load (as documented in the medical record). 11. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 12. The effects of pulsed electric field on the developing human fetus are unknown. For this reason individuals of reproductive potential must agree to use adequate contraception: (e.g., hormonal or barrier method of birth control; abstinence, etc.) for the duration of study participation and for 4 weeks after last administration of study treatment. Should a study participant become pregnant or suspect pregnancy while participating in this study, they should inform their treating physician immediately.
Exclusion criteria
1. Has not recovered from adverse events due to prior/concurrent systemic anti-cancer therapy to ≤ Grade 2 (CTCAE v5.0) or baseline (other than alopecia). 2. Individuals with pacemakers or other electronic implant devices. 3. Individuals who are unable or unwilling, or with medical contraindication, to undergo moderate sedation and local anesthesia. 4. Pregnant individuals are excluded from this study because there is unknown risk of PEF on fetus. 5. Breastfeeding/chestfeeding individuals are excluded from this study because there is unknown risk on nursing infants; breastfeeding/chestfeeding should be discontinued prior to initiating study treatment. 6. Individuals with any condition or social circumstance that, in the opinion of the treating investigator, would impair the participant's ability to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with treatment-emergent adverse events | Up to 4 weeks | Proportion of participants who experience adverse event from the Pulsed Electric Field (PEF) ablation treatment. Standard deviation and 95% confidence intervals will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change of score on European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ BR-23) | Up to 4 weeks | 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. |
| Mean change of score on EuroQol five-dimensional Questionnaire (EQ-5D) | Up to 4 weeks | 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. |
| Mean technical success rate of Pulsed Electric Field (PEF) ablation | Up to 1 day | 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. |
Countries
United States
Contacts
CONTACTMaya Aslam
PRINCIPAL_INVESTIGATORRyan Kohlbrenner, MD
University of California, San Francisco
Outcome results
None listed