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

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07227831
Status
Not Yet Recruiting

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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
Feb 28, 2026
Status verified
Nov 2025
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

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