A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer

Part of paid clinical trials in Bay City, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07227831
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TheraBionic 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

Study Details

The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are: * will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer * the long term safety and tolerability of the TheraBionic P1 device * assessment of how the disease responded to the TheraBionic P1 device

Key Dates

First listed
Nov 13, 2025
Start date
Jan 16, 2026
Status verified
Aug 2026
Primary completion
May 22, 2027
Completion
May 22, 2028

Study Design

Enrollment
82 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TheraBionic P1 device
    Self administered Amplitude-modulated electromagnetic fields three times daily

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Karmanos Cancer Institute at McLaren Bay RegionBay CityMichigan48706
989-667-2370
Karmanos Cancer Institute at McLaren ClarkstonClarkstonMichigan48346
248-922-6650
Karmanos Cancer InstituteDetroitMichigan48201
Hadeel Assad, MD
18005276266
Karmanos Cancer Institute at McLaren FlintFlintMichigan48532
1-810-342-3800
Karmanos Cancer Institute at McLaren Lapeer RegionLapeerMichigan48446
1-810-667-4994
Karmanos Cancer Institute at McLaren MacombMount ClemensMichigan48043
1-586-493-7510
Karmanos Cancer Institute at McLaren NorthernPetoskeyMichigan49770
231-487-3390
Karmanos Cancer Institute at McLaren Port HuronPort HuronMichigan48060
1-810-982-5200

Find similar trials in Bay City, MI

Nationwide
Breast cancer trialsOncology trialsBreast oncology trialsWomen's health trials
By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Karmanos Cancer Institute at McLaren Bay Region· Bay City, MIKarmanos Cancer Institute at McLaren Clarkston· Clarkston, MIKarmanos Cancer Institute· Detroit, MIKarmanos Cancer Institute at McLaren Flint· Flint, MIKarmanos Cancer Institute at McLaren Lapeer Region· Lapeer, MIKarmanos Cancer Institute at McLaren Macomb· Mount Clemens, MI

Related Studies