We are pleased to announce that the final report has been published for the investigator-initiated Specified Clinical Study conducted at Edogawa Hospital in Tokyo.
Our company entered into an agreement to support the study, which targeted recurrent breast cancer, and we contributed by supplying our boron drug, Steboronine®, developed for use in Boron Neutron Capture Therapy (BNCT).
The following is a summary of the final report released in relation to the study.
Study Overview
・Objective: To evaluate the safety and efficacy of BNCT in patients with recurrent breast cancer after radiotherapy.
・Design: World’s first investigator-initiated clinical study of BNCT in recurrent breast cancer (5 patients, single-center).
・Method: Conducted at Edogawa Hospital using the neutron irradiation device developed by CICS, in combination with Steboronine®.
Key Results
・No Grade 4 or higher acute adverse events or device-related malfunctions were observed.
・Adverse events that did occur were manageable, confirming BNCT’s generally favorable safety profile.
・Among the 5 patients treated, 4 achieved partial response within 90 days (overall response rate: 80%).
・In 3 cases, tumor shrinkage of 50% or more was confirmed at the 90-day evaluation.
These findings suggest that BNCT may represent a promising new therapeutic option for patients with recurrent breast cancer following radiotherapy.
Clinical Context
In recurrent breast cancer after radiotherapy, additional surgery is often not feasible, and re-irradiation of the same site is generally not available. For patients unwilling to undergo mastectomy, needs for local disease control remain high.
Because BNCT selectively destroys cancer cells and can be applied to previously irradiated areas, it may provide an important alternative in such cases.
Outlook
In collaboration with medical institutions, we will continue efforts to make BNCT available as a treatment option for patients as quickly as possible.
For further details of the study, please refer to the clinical research database (jRCT): link.