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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Recruitment opened
    • Trial sites expanded: 0 → 8 locations
    • Start date changed from estimate of Feb 2026 to Jan 16, 2026
    • Eligibility criteria expanded, about 10 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT07227831
Lead Sponsor Barbara Ann Karmanos Cancer Institute
Conditions
(from sponsor)		 HER2-negative Breast Cancer, Hormone Receptor Positive Tumor, Advanced Breast Cancer, Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 82 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov