Combining Focused Ultrasound and Immunotherapy to Treat Breast Cancer
Investigators have announced a new clinical trial to test whether high-intensity focused ultrasound (HIFU) and the checkpoint inhibitor pembrolizumab can jointly prove to be an effective treatment of advanced, metastatic breast cancer. Co-lead investigators of this pilot trial are David Brenin, MD, FACS, and Patrick Dillon, MD, both of the University of Virginia School of Medicine.
Preclinical studies suggest this type of ultrasound may make breast cancer cells visible to the immune system, rendering them vulnerable to immunotherapy. This is reportedly the first clinical trial to combine HIFU with immunotherapy.
“The immune system does not recognize most breast cancers as invading or foreign cells, so the body does not mount an immune response against it,” said Dr. Brenin in a press release. “Focused ultrasound induces a local immune response and may have the ability to change that paradigm, enabling a medication like [pembrolizumab] to make a difference.”
The study will enroll 15 women and randomize them into two groups: one will receive pembrolizumab first and then HIFU, and the second will receive HIFU first and then pembrolizumab. The primary study aims are to assess the adverse event profile of the combination therapy. Secondary objectives will be to compare CD8-positive T-cell responses at the periablation zones, to assess clinical responses at local and distant metastatic sites by computed tomography, and to evaluate progression-free and overall survival.