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).
Single group
TheraBionic P1
DeviceAmplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening
Progression Free Survival (PFS)
PFS is defined as the time duration in days from treatment start to progression per physician discretion or death from any cause. Progression will be assessed every 2-3 months for 5 years
Tolerability of the TheraBionic P1 device
Tolerability will be assessed by the proportion of participants rated as "tolerating treatment" (yes/no) throughout therapy, based on investigator assessment at each 4-week visit. Participants who discontinue treatment due to device-related symptoms or adverse events will be classified as not tolerating treatment.
Overall Survival (OS)
The OS is the length of time in days from the start of treatment that participants are still alive and finishing at the date of death from any cause. Participants' survival status will be assessed every 2-3 months for 5 years after the start of TheraBionic P1 treatment.
Overall Response Rate (ORR)
The ORR is calculated as the proportion of participants with complete response (CR) or partial response (PR) per physician discretion. ORR will be assessed every 2-3 months for 5 years after the start of TheraBionic P1 treatment.
Disease control rate (DCR)
DCR is defined as the proportion of participants with complete response (CR), partial response (PR), or stable disease (SD) per physician discretion. DCR will be assessed every 2-3 months for 5 years after the start of TheraBionic P1 treatment.
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