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
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
Participant must have refractory disease and failed, not tolerated, or progressed on at least two lines of prior standard therapeutic regimens for mTNBC.
Participant must be a woman of 22 years of age or older.
Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints.
Participants with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain magnetic resonance imaging (MRI) with and without contrast within 8 weeks of signing consent.
Participants who are taking any other investigational drugs
Participants who are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued
Barbara Ann Karmanos Cancer Institute
Lead sponsor
THERABIONIC INC.
Collaborator
Ucancervive
Collaborator