NCT07218432 · Barbara Ann Karmanos Cancer Institute
A Study of the TheraBionic P1 Device in Breast Cancer
What this study is about
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.
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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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Clarkston, Michigan
- Detroit, Michigan
- Farmington Hills, Michigan
- Flint, Michigan
- Lansing, Michigan
- Lapeer, Michigan
- Petoskey, Michigan
- Port Huron, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 21, 2026 · Source of record for eligibility and locations