Study of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer After Progression

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07672431
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TheraBionic P1 — DEVICE
    TheraBionic P1 is amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device added to any third line treatment for triple negative breast cancer

Study Details

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

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Amplitude-modulated radiofrequency electromagnetic fields device plus third line treatment
    TheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device 3 times daily (continuous) plus standard of care third line treatment

Primary Outcome Measure

6 month Progression Free Survival (PFS6) [ Time Frame: 6 months after start of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Jailan Elayoubi, M.D.
1-800-527-6266

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