Could electromagnetic fields help fight breast cancer?
NCT ID NCT07227831
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests a device called TheraBionic P1 that sends low-level electromagnetic fields to the body. It is for people with advanced hormone-positive, HER2-negative breast cancer who have already tried standard treatments. The goal is to see if the device can help control the cancer and improve survival, while also checking its safety and tolerability.
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 offer a new, non-invasive option to help control advanced breast cancer and extend survival when other treatments have stopped working.
- What could go wrong
- This is an early phase 2 trial with only 82 participants, so results may not apply to everyone. The device is experimental and it is unknown if it will meaningfully improve survival or quality of life.
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 82 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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May 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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Anyone
- 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 locally advanced/unresectable or metastatic Hormone Receptor (HR) positive, Human Epidermal growth factor receptor 2 (HER2) negative breast cancer as defined by the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (estrogen receptor \[ER\] and/or progesterone receptor \[PR\] \>1% and HER2 negative by immunohistochemistry \[IHC\] and/or fluorescent in situ hybridization \[FISH\]). * Participant must have received and progressed on or are intolerant to all therapies known to confer overall survival benefit, including at least one line of endocrine + CDK4/6 inhibitor therapy AND one line of cytotoxic such as chemotherapy and/or antibody drug conjugates (ADCs). * Participant must be a woman ≥ 22 years old and must be able to understand and sign an informed consent form. * Participant must have a life expectancy of at least 3 months. * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score 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 childbearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session. * Participants must meet one of the following: * Surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) * Post-menopausal, defined as no menses for at least 12 months prior to the screening visit without alternative medical causation. * Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. Periodic abstinence methods such as calendar, ovulation, symptothermal, or post ovulation tracking are not acceptable. * Not in a sexual relationship in which they may become pregnant (i.e. same-sex relationship) * If they are of childbearing potential, agree to use at least one method of contraception. Withdrawal is not an acceptable contraceptive method. Exclusion Criteria: * 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. 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 at McLaren Bay Region
RECRUITINGBay City, Michigan, 48706, 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 Lapeer Region
RECRUITINGLapeer, Michigan, 48446, United States
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Karmanos Cancer Institute at McLaren Macomb
RECRUITINGMount Clemens, Michigan, 48043, United States
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Karmanos Cancer Institute at McLaren Northern
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 a blood test reveal when breast cancer treatment stops working?
- New antibody aims to preserve immune checkpoint while fighting cancer
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- Can a Two-Drug combo outsmart resistant breast and ovarian cancers?
- Can a new drug combo outsmart breast cancer that resists current therapy?