The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are:
* will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer * the long term safety and tolerability of the TheraBionic P1 device * assessment of how the disease responded to the TheraBionic P1 device
Participant must have locally advanced/unresectable or metastatic Hormone Receptor (HR) positive, Human Epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (estrogen receptor [ER] and/or progesterone receptor [PR] >1% and HER2 negative by immunohistochemistry [IHC] and/or fluorescent in situ hybridization [FISH]).
Participant must have received and progressed on or are intolerant to all therapies known to confer overall survival benefit, including at least one line of endocrine + CDK4/6 inhibitor therapy AND one line of cytotoxic such as chemotherapy and/or antibody drug conjugates (ADCs).
Participant must be a woman ≥ 22 years old and must be able to understand and sign an informed consent form.
Participant must have a life expectancy of at least 3 months.
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 that are taking any other investigational drugs.
Participants that are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued.
Participants with active oral mucosal inflammation, ulceration, or other pathology that 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).