A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
Barbara Ann Karmanos Cancer Institute
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
- Age range
- 22+ years
- Sex
- Female
- Healthy volunteers
- No
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. *…
Interventions
- DeviceTheraBionic P1 Device
Amplitude-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.
Locations (8)
- Karmanos Cancer Institute at McLaren ClarkstonClarkston, Michigan
- Karmanos Cancer InstituteDetroit, Michigan
- Karmanos Cancer Institute Weisberg Cancer Treatment CenterFarmington Hills, Michigan
- Karmanos Cancer Institute at McLaren FlintFlint, Michigan
- Karmanos Cancer Institute at McLaren Greater LansingLansing, Michigan
- Karmanos Cancer Institute at McLaren Lapeer RegionLapeer, Michigan