Trials / Not Yet Recruiting
Not Yet RecruitingNCT07227831
A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer
A Phase 2 Study of TheraBionic P1 Device for Patients With Metastatic Hormone Positive Breast Cancer Post Endocrine Therapy
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 82 (estimated)
- Sponsor
- Barbara Ann Karmanos Cancer Institute · Academic / Other
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Not accepted
Summary
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
Conditions
- HER2-negative Breast Cancer
- Hormone Receptor Positive Tumor
- Advanced Breast Cancer
- Metastatic Breast Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TheraBionic P1 | Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening |
Timeline
- Start date
- 2026-02-01
- Primary completion
- 2027-05-22
- Completion
- 2028-05-22
- First posted
- 2025-11-13
- Last updated
- 2025-11-13
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07227831. Inclusion in this directory is not an endorsement.