Metastatic Breast Cancer study: Pulsed Electric Field vs Tumor Ablation
Official title Pulsed Electric Field Ablation for Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07487844
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants must have histologically or cytologically confirmed metastatic breast cancer.
- Confirmed documented soft tissue involvement via imaging or biopsy, with at least one measurable lesion with a cutaneous and/or subcutaneous...
- 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...
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
You likely can't join if
- Has not recovered from adverse events due to prior/concurrent systemic anti-cancer therapy to ≤ Grade 2 (CTCAE v5.0) or baseline (other than...
- Individuals with pacemakers or other electronic implant devices.
- Individuals who are unable or unwilling, or with medical contraindication, to undergo moderate sedation and local anesthesia.
- Pregnant individuals are excluded from this study because there is unknown risk of PEF on fetus.
- Breastfeeding/chestfeeding individuals are excluded from this study because there is unknown risk on nursing infants
- Individuals with any condition or social circumstance that, in the opinion of the treating investigator, would impair the participant's ability to...
See the full eligibility criteria
- Participants must have histologically or cytologically confirmed metastatic breast cancer.
- 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...
- 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...
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Absolute neutrophil count ≥1,500/microliter (mcL).
- Platelets ≥100,000/mcL.
- Not on or able to withhold anticoagulation or antiplatelet therapy per Society of treatment Radiology periprocedural guideline.
- 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.
- 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.
- 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...
- Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible...
- 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...
- 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).
- Individuals with pacemakers or other electronic implant devices.
- Individuals who are unable or unwilling, or with medical contraindication, to undergo moderate sedation and local anesthesia.
- Pregnant individuals are excluded from this study because there is unknown risk of PEF on fetus.
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.