A Study of the TheraBionic P1 Device in Breast Cancer
Trial Parameters
Brief Summary
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.
Eligibility Criteria
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) College of American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) \>1% and HER2 negative by immunohistochemistry \[IHC\] and/or fluorescent in situ hybridization \[FISH\]). * Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery. * Participant must be available for at least two weeks of TheraBionic treatment prior to 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 be willing to sign it * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance statu