Could electromagnetic waves help shrink breast tumors before surgery?
NCT ID NCT07218432
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing whether a device called TheraBionic P1, which delivers targeted electromagnetic fields, can affect breast cancer tumors before surgery. About 24 women with early-stage, hormone receptor-positive, HER2-negative breast cancer will use the device three times daily for 60 minutes each session. Researchers will measure how many cancer cells remain in the removed tumor tissue to see if the treatment has any effect.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TheraBionic P1 device (amplitude-modulated electromagnetic fields)
- What this could lead to
- If it works, this could point toward a non-invasive, drug-free way to shrink breast cancer tumors before surgery.
- What could go wrong
- This is a very early, small pilot study with only 24 participants. It may show no effect on tumors, and the device is not a standard treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Karmanos Cancer Institute
RECRUITINGDetroit, Michigan, 48201, United States
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Karmanos Cancer Institute Weisberg Cancer Treatment Center
RECRUITINGFarmington Hills, Michigan, 48334, United States
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Karmanos Cancer Institute at McLaren Clarkston
RECRUITINGClarkston, Michigan, 48346, United States
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Karmanos Cancer Institute at McLaren Flint
RECRUITINGFlint, Michigan, 48532, United States
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Karmanos Cancer Institute at McLaren Greater Lansing
RECRUITINGLansing, Michigan, 48910, United States
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Karmanos Cancer Institute at McLaren Lapeer Region
RECRUITINGLapeer, Michigan, 48466, United States
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Karmanos Cancer Institute at McLaren Northern Michigan
RECRUITINGPetoskey, Michigan, 49770, United States
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Karmanos Cancer Institute at McLaren Port Huron
RECRUITINGPort Huron, Michigan, 48060, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an oral HER2 drug boost Chemo's punch in HER2-Low breast cancer?
- Can a blood test reveal when breast cancer treatment stops working?
- Can a platform trial match the right drug combo to each tumor?
- Can a Two-Drug combo shrink BRCA-Linked breast tumors?
- Can a new drug make hormone therapy work better for breast cancer?