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Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer

NCT03237572 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-02-09

Study results available
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Summary

This pilot study evaluates the use of high-intensity focused ultrasound (HIFU) combined with pembrolizumab in patients with metastatic breast cancer. One-half of participants will be randomized to receive the first dose of pembrolizumab after HIFU and one-half of participants will be randomized to receive their first dose of pembrolizumab before HIFU.

Conditions

Interventions

DRUG

Pembrolizumab

Pembrolizumab (200 mg)

DEVICE

High-intensity focused ultrasound (HIFU)

Ablation will target 50% of the tumor, up to 3 cubic centimeters

Sponsors & Collaborators

  • Patrick Dillon, MD

    lead OTHER

Principal Investigators

  • Patrick Dillon, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-25
Primary Completion
2022-06-01
Completion
2022-06-17
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03237572 on ClinicalTrials.gov