A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
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.
Arms & 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.
Outcome measures
Primary
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
Time frame: At time of surgery (after approximately 2 weeks of treatment and tumor resection)
Secondary
Changes in microRNA expression in tumor tissue
Time frame: Baseline to post-surgical resection
Changes in Ki-67 expression in tumor tissue
Time frame: Baseline to post-surgical resection
Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue
Time frame: Baseline to post-surgical resection
Changes in cell cycle arrest marker p27 in tumor tissue
Time frame: Baseline to post-surgical resection
Overall survival (OS)
Time frame: Up to 5 years post-surgery
Progression Free Survival (PFS)
Time frame: Up to 5 years post-surgery
Eligibility criteria
Study locations (8)
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, 48346
Karmanos Cancer Institute
Detroit, Michigan, 48201
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, 48334
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, 48532
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, 48910
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, 48466
Karmanos Cancer Institute at McLaren Northern Michigan
Petoskey, Michigan, 49770
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, 48060