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

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 have a washout period of at least 14 days between the last line of treatment and the start of study treatment.

Participant must be a woman of 22 years of age or older.

Participant must have a life expectancy of at least three months

Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2

It is unknown what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner and donating sperm starting at initiation of treatment up until at least 12 weeks after treatment discontinuation

* Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy)

* Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation.

* Agree to practice true abstinence from sexual intercourse when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence methods such as calendar, ovulation, symptothermal, or post ovulation tracking are not acceptable.

* Not in a sexual relationship in which they may become pregnant (i.e. same-sex relationship)

* If they are of child-bearing potential, agree to use at least one highly effective AND at least one additional method of contraception. Withdrawal is not an acceptable contraceptive method.

What this study is about