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Study of the TheraBionic P1 Device in Early-Stage Breast Cancer

This study is looking at how a device called TheraBionic P1 might affect early-stage breast cancer. The TheraBionic P1 device uses amplitude-modulated electromagnetic fields. You would use this device three times a day for 60 minutes each time, in the morning, midday, and evening, before having surgery for your breast cancer. This study is for women aged 22 and older who have early-stage breast cancer (Stage I, II, or IIIA) that is hormone receptor positive (meaning it responds to hormones) and HER2-negative (meaning it doesn't have too much of a protein called HER2). The main goal is to see how the cancer responds to this treatment by the time of surgery, which is about two weeks after starting treatment. The study plans to enroll 24 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 24 women.
What's involved
You would self-administer the TheraBionic P1 device three times a day for 60 minutes each time (morning, midday, evening) for approximately two weeks before surgery.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the time of surgery, after approximately two weeks of treatment.

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NCT07218432

A Study of the TheraBionic P1 Device in Breast Cancer

Recruiting
NAAges 22+InterventionalTreatment
Barbara Ann Karmanos Cancer Institute
~24 participants
Updated 2026-04-21 on ClinicalTrials.gov
What's tested:TheraBionic P1 Device

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathological Response to Treatment
Measured over At time of surgery (after approximately 2 weeks of treatment and tumor resection)

Conditions

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

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Where it's being run

8 sites across 1 states
Michigan8

Study leadership

  • Lubina Arjyal, M.D. · PRINCIPAL_INVESTIGATOR · Wayne State University

Who to contact

Lubina Arjyal, M.D.
[email protected]
1-800-karmanos
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) \>1% and HER2 negative by immunohistochemistry \[IHC\] and/or fluorescent in situ hybridization \[FISH\]).
Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery.
Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection
Participant must have archival tissue available.
Participant must be a woman aged 22 years or older
Participant must be able to understand a written informed consent document and be willing to sign it
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
It is not known what effects this treatment has on human pregnancy or development of the embryo or fetus. Therefore, women of child-bearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session

Exclusion

Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy
Participants with known active secondary malignancy, unless, in the opinion of the investigator, it is unlikely to interfere with the safety and efficacy of the endpoints
Participants that are taking any other investigational drugs
Participants that are pregnant or breastfeeding due to the unknown but potential risk for adverse events. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued
Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for example: mucositis, thrush, bleeding mucosal lesions, oral herpes, aphthous stomatitis, mouth ulcers, chancre sores, gingivostomatitis, herpangina, aphthae).
Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, ascorbic acid/vitamin C, etc.) unless their medical treatment is discontinued at least one day prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study.
Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to use the device
Participants with a known severe (e.g., anaphylactic) allergy to nickel.

What this trial measures

  • Pathological Response to TreatmentAt time of surgery (after approximately 2 weeks of treatment and tumor resection)

    Proportion of responders based on residual cancer cells in a resection specimen will be quantified. The response rate will be estimated as the proportion of patients who respond to treatment relative to all patients. The corresponding two-sided 95% confidence interval (CI) will be calculated using Clopper and Pearson's method