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

NCT07227831 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-11-13

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

TheraBionic P1

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

Sponsors & Collaborators

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2027-05-22
Completion
2028-05-22
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07227831 on ClinicalTrials.gov