A Pilot Study of the Efficacy of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer in the Third-line Setting
Barbara Ann Karmanos Cancer Institute
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
Eligibility
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Participant must have histologically confirmed invasive breast cancer that is hormone receptor (HR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative according to the American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Estrogen Receptor (ER) and progesterone receptor (PR) \< 1% and HER2 negative by immuno-histochemistry (IHC) and/or fluorescent in situ hybridization \[FISH\] * Participant must have evaluable disease as defined by the investigator using CT, MRI, or positron emission tomography (PET) scan * Pa…
Interventions
- DeviceTheraBionic P1
TheraBionic P1 is amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device added to any third line treatment for triple negative breast cancer
Location
- Karmanos Cancer InstituteDetroit, Michigan