A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer

The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are: * will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer * the long term safety and tolerability of the TheraBionic P1 device * assessment of how the disease responded to the TheraBionic P1 device

NCT Number	NCT07227831
Lead Sponsor	Barbara Ann Karmanos Cancer Institute
Conditions	HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Advanced Breast Cancer, Metastatic Breast Cancer
Enrollment	82 participants
Start Date	2026-02
Primary Completion	2027-05-22 (estimated)
Study Completion	2028-05-22 (estimated)
Updated on ClinicalTrials.gov	2025-11-13