This clinical trial studies how well amplitude-modulated (AM) radiofrequency (RF) electromagnetic field (EMF) therapy using the TheraBionic P1 device works in treating patients with hormone receptor (HR) positive HER2 negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced), that cannot be removed by surgery (unresectable), or that has spread from where it first started (primary site) to other places in the body (metastatic) and that has grown, spread, or gotten worse on previous therapy (progressed). The Therabionic P1 device delivers treatment with low-level RF EMFs that are amplitude-modulated at tumor-specific frequencies designed to block the growth of tumor cells without affecting the growth of normal cells.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07227831.
Locations matching your search criteria
United States
Michigan
Detroit
Wayne State University/Karmanos Cancer InstituteStatus: Active
Contact: Hadeel Assad
Phone: 313-576-8716
PRIMARY OBJECTIVE:
I. To assess progression-free survival (PFS) in breast cancer patients receiving amplitude-modulated electromagnetic field therapy (AM RF EMF therapy) delivered using the TheraBionic P1 device.
SECONDARY OBJECTIVES:
I. To assess treatment tolerability and safety of breast cancer-specific AM RF EMF therapy.
II. To estimate overall survival (OS).
III. To estimate overall response rate (ORR).
IV. To estimate disease control rate (DCR).
V. To estimate duration of response (DOR).
VI. To estimate time to progression (TTP).
OUTLINE:
Patients undergo AM RF EMF therapy via TheraBionic P1 device over 1 hour three times daily (TID) on study. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study.
After completion of study treatment, patients are followed up at 1 week and then every 2-3 months for 60 months after start of treatment.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationWayne State University/Karmanos Cancer Institute
Principal InvestigatorHadeel Assad