The focused ultrasound research community is actively pursuing the treatment of various stages of breast cancer in nine ongoing clinical trials worldwide.
According to the World Health Organization, breast cancer is the most common cancer among women worldwide, affecting 2.1 million women each year. It also causes the greatest number of global cancer deaths in women per year.
The standard treatment for breast cancer includes various combinations of surgery, chemotherapy, radiation, hormone therapy and targeted therapies (such as Herceptin.) Although there have been significant advances in breast cancer treatment over the past 20 years, there is plenty of room for improvement. Focused ultrasound holds promise to provide a noninvasive and radiation-free treatment option.
“The Foundation is thrilled to see an increase in the number of clinical trials exploring the use of focused ultrasound to treat breast tumors,” said Foundation Director of Clinical Relationships Suzanne LeBlang, MD. “Although earlier studies with focused ultrasound and breast cancer involved just thermal ablation, new important and promising preclinical research has now paved the way for additional clinical studies.”
The ongoing clinical trials use several of focused ultrasound’s various mechanisms of action, including tissue destruction via thermal ablation of tumors, enhanced of drug delivery, immunomodulation, and radiation sensitization.
Clinical Trials Using Focused Ultrasound-Induced Thermal Ablation
Current clinical trials in Switzerland and the Netherlands, using the Philips Sonalleve® MR-HIFU Breast Therapy System, and in France, using a novel HIFU system, are exploring the use of focused ultrasound–induced thermal ablation for primary breast cancer masses. These trials were designed with knowledge gained from prior focused ultrasound clinical studies of more than 234 patients. In those initial studies, researchers reported a 20 percent to 100 percent tumor ablation. Encouragingly, there were no significant side effects reported in these early studies.
Given the varying degrees of tumor volume destroyed in the initial studies, the current clinical trials aim to determine not only the safety of this technology but also consistency across treatments in terms of the ability of focused ultrasound to achieve complete ablation of breast tumors. Because focused ultrasound is a noninvasive procedure, the study methods use repeat biopsy, surgical resections, and/or follow up MRI scans to ensure complete ablation of the tumor.
Clinical Trials Exploring Focused Ultrasound’s Other Biological Mechanisms
Focused ultrasound has been found to generate other therapeutic effects in the body that could treat breast cancer, including an anti-tumor immune response or enhanced local delivery of chemotherapeutics and immunotherapeutic agents.
At the University of Virginia (UVA), a clinical trial using the Theraclion system is exploring the use of focused ultrasound combined with an immunotherapy drug to treat metastatic breast cancer. The UVA research team is enrolling 15 patients with unresectable or metastatic breast cancer to evaluate the safety and efficacy of focused ultrasound combined with Keytruda (pembrolizumab). This is the first-in-the-world clinical trial using a combination of the two therapies to treat breast cancer.
Another trial, also using the Theraclion system, recently began at UVA to investigate the use of focused ultrasound with and without PD-1 blockade in advanced solid tumors, including breast cancers.
A clinical trial that employs focused ultrasound–induced blood brain barrier opening for targeted drug delivery in patients with HER2-positive breast cancer metastases to the brain has begun enrolling patients in Canada. This study is using Insightec's Exablate Neuro device.
A trial in Norway is exploring the potential of focused ultrasound to enhance drug delivery to liver metastases caused by breast or colorectal cancer. Researchers in the Netherlands are also using the Sonalleve system to explore the potential of focused ultrasound to enhance drug delivery, but in patients with stage 4 breast cancer. Both groups of scientists hope that focused ultrasound will increase drug delivery to the tumor, decrease total body drug concentration, and produce fewer systemic side effects than traditional therapies.
Lastly, Sunnybrook Health Sciences Centre in Toronto, Canada, recently began enrolling patients with locally advanced breast cancer and chest wall tumors in a study that examines the effect of ultrasound-stimulated microbubble (MB) treatment combined with radiation therapy. This clinical trial is designed to determine whether this novel approach is safe, with a secondary aim of evaluating the tumor response to focused ultrasound plus MBs and radiation.
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