NCT03237572

Focused Ultrasound and Pembrolizumab in Metastatic Breast Cancer

Focused Ultrasound Therapy to Augment Antigen Presentation and Immune-Specificity of Checkpoint Inhibitor Therapy With Pembrolizumab in Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Patrick Dillon, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Pembrolizumab (200 mg)
DEVICE	High-intensity focused ultrasound (HIFU)	Ablation will target 50% of the tumor, up to 3 cubic centimeters

Timeline

• Start date: 2017-09-25
• Primary completion: 2022-06-01
• Completion: 2022-06-17
• First posted: 2017-08-02
• Last updated: 2026-02-09
• Results posted: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study