A Study of the TheraBionic P1 Device in Breast Cancer

Inclusion Criteria:

• Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2)negative according to the 2010 American Society of Clinical Oncology (ASCO) Collegeof American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) >1%and HER2 negative by immunohistochemistry [IHC] and/or fluorescent in situhybridization [FISH]).

• Participant must have early-stage operable disease (stage I-II or III who haveplanned upfront surgery) and agree to definitive upfront surgery.

• Participant must be available for at least two weeks of TheraBionic treatment priorto scheduled resection

• Participant must have archival tissue available.

• Participant must be a woman aged 22 years or older

• Participant must be able to understand a written informed consent document and bewilling to sign it

• Participant must have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0-2.

• It is not known what effects this treatment has on human pregnancy or development ofthe embryo or fetus. Therefore, women of child-bearing potential must agree to avoidbecoming pregnant starting at initiation of treatment up until at least 30 daysafter the last TheraBionic P1 session

Exclusion Criteria:

• Participants that are receiving or will receive neoadjuvant chemotherapy orneoadjuvant hormonal therapy

• Participants with known active secondary malignancy, unless, in the opinion of theinvestigator, it is unlikely to interfere with the safety and efficacy of theendpoints

• Participants that are taking any other investigational drugs

• Participants that are pregnant or breastfeeding due to the unknown but potentialrisk for adverse events. If a breastfeeding participant would like to be part ofthis study, breastfeeding must be discontinued

• Participants with active oral mucosal inflammation, ulceration, or other pathologythat could interfere with the use of TheraBionic P1 device (for example: mucositis,thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers,chancre sores, gingivostomatitis, herpangina, aphthae).

• Participants receiving calcium channel blockers and any agent blocking L-type orT-type voltage gated calcium channels (for example: amlodipine, nifedipine,ethosuximide, ascorbic acid/vitamin C, etc.) unless their medical treatment isdiscontinued at least one day prior to treatment. Participant must agree to abstainfrom using calcium channel blockers for the duration of treatment on study.

• Participants that do not agree to be followed according to the study protocol orhave cognitive or physical inability to use the device