RecruitingNot ApplicableNCT07218432

A Study of the TheraBionic P1 Device in Breast Cancer

A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting

Sponsor

Barbara Ann Karmanos Cancer Institute

Enrollment

24 participants

Start Date

Oct 1, 2026

Study Type

INTERVENTIONAL

Conditions

HER2-negative Breast Cancer Breast Cancer Stage I Breast Cancer Stage II Hormone Receptor Positive Tumor Breast Cancer Stage IIIA

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.

Eligibility

Sex: FEMALEMin Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a device called the TheraBionic P1, which uses low levels of radio waves to treat breast cancer before surgery. The device is worn at home and may shrink tumors or slow cancer growth. Researchers want to see if using it for two weeks before a planned operation makes a difference. **You may be eligible if...** - You are a woman aged 22 or older - You have breast cancer that is hormone receptor (HR) positive and HER2 negative - Your cancer is early-stage (Stage I, II, or certain Stage III) and you are planned for surgery - You are available to use the device for at least two weeks before your operation - You have archived tumor tissue available and are generally well enough for the study **You may NOT be eligible if...** - You have a different type of breast cancer (e.g., HER2 positive, triple-negative) - You are not planned for upfront surgery - You are pregnant or trying to become pregnant - Your general health is too poor to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.