Phase 2 TheraBionic P1 amplitude‑modulated RF electromagnetic field (tumor‑frequency EMF) device in HR+ breast cancer.

This Phase 2, open-label, single-arm study tests the TheraBionic P1 mouth device as a self-administered, non-drug intervention for locally advanced/unresectable or metastatic hormone receptor–positive (ER/PR >1% in most definitions), HER2-negative breast cancer after progression on prior standard therapies. Patients deliver low-level radiofrequency electromagnetic fields that are amplitude-modulated at tumor-specific frequencies (device-based “tumor-frequency EMF” approach intended to inhibit tumor cell growth while sparing normal tissue). The sponsor is Barbara Ann Karmanos Cancer Institute / Wayne State University (Karmanos/WSU), and key endpoints include progression-free survival with secondary endpoints including overall survival, response metrics, and long-term tolerability; imaging and blood collections are part of on-study monitoring and follow-up continues for years. The commercial/scientific angle is a home-use, frequency-tuned electromagnetic modality being evaluated in a setting where patients often cycle through endocrine therapy with targeted agents (commonly CDK4/6 inhibitors earlier, then endocrine switches such as oral SERDs when eligible, mTOR/PI3K-pathway combinations when biomarker-appropriate) and eventually chemotherapy and/or antibody–drug conjugates, so the trial asks whether a device can extend disease control after typical endocrine options are exhausted.