Study of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer After Progression
NCT07672431 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-06-29
Summary
The goal of this clinical trial is to learn if adding the TheraBionic P1 device to standard of care third line treatment for adult women with metastatic triple negative breast cancer (mTNBC) who have failed, not tolerated, or progressed on standard first- and second-line treatment options can work better than the standard of care alone. The main questions it aims to answer is:
* will the addition of the TheraBionic P1 device to standard of care third line treatment affect progression free and overall survival in these participants
Conditions
Interventions
- DEVICE
-
TheraBionic P1
TheraBionic P1 is amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device added to any third line treatment for triple negative breast cancer
Sponsors & Collaborators
-
THERABIONIC INC.
collaborator OTHER -
Ucancervive
collaborator UNKNOWN -
Barbara Ann Karmanos Cancer Institute
lead OTHER
Principal Investigators
-
Jailan Elayoubi, M.D. · Barbara Ann Karmanos Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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