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.
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.
Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy
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 due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued
Single group
TheraBionic P1 Device
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 prior to surgical resection of early stage breast cancer.
Pathological Response to Treatment
Proportion of responders based on residual cancer cells in a resection specimen will be quantified. The response rate will be estimated as the proportion of patients who respond to treatment relative to all patients. The corresponding two-sided 95% confidence interval (CI) will be calculated using Clopper and Pearson's method
Changes in microRNA expression in tumor tissue
Changes in microRNA expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Changes in Ki-67 expression in tumor tissue
Changes in Ki-67 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue
Changes in CC3 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Changes in cell cycle arrest marker p27 in tumor tissue
Changes in p27 expression in tumor tissue pre- and post-treatment will be calculated as the difference between pre- and post-treatment expression values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences.
Positron Emission Tomography with 3'-Deoxy-3'-18F-Fluorothymidine (PET-FLT) association of response to treatment
Changes in the SUV max as measured by FLT-PET prior to treatment compared to after treatment and before resection. SUV (standard uptake value) max values will be log-transformed and descriptively summarized using the mean, standard deviation, and two-sided 95% CI. Changes in SUV max pre- and post-treatment will be calculated as the difference between the pre- and post-treatment values with two-sided 95% CI estimated using a standard t-distribution-based formula for paired differences. The association between changes in SUV max and response will be explored using logistic regression analysis. Optional study for the first 5 participants.
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