Back to search results

Study of TheraBionic P1 for Metastatic Triple Negative Breast Cancer

This study is looking at whether adding the TheraBionic P1 device to standard third-line treatment can help adult women with metastatic triple negative breast cancer (mTNBC). This is for women whose cancer has progressed or who couldn't tolerate earlier treatments. The TheraBionic P1 device uses amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF). Researchers want to see if this combination improves how long participants live without their cancer growing (progression-free survival) and overall survival. To join, you must have breast cancer that is hormone receptor (HR) negative and HER2 negative. The study aims to enroll 24 participants, and the main goal is to measure progression-free survival after 6 months.

Study design
This is an interventional study with an unclear status, planning to enroll 24 adult women. It is testing the TheraBionic P1 device in combination with standard third-line treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures progression-free survival at 6 months after the start of treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07672431

Study of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer After Progression

Not Yet Recruiting
NAAges 22+InterventionalTreatment
Barbara Ann Karmanos Cancer Institute
~24 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:TheraBionic P1

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
6 month Progression Free Survival (PFS6)
Measured over 6 months after start of treatment

Conditions

Triple Negative Breast Cancer

Explore related trials

Triple-negative breast cancer

NCT07672431

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Karmanos Cancer Institute

    Detroit, Michiganstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jailan Elayoubi, M.D. · PRINCIPAL_INVESTIGATOR · Barbara Ann Karmanos Cancer Institute

Who to contact

Jailan Elayoubi, M.D.
[email protected]
1-800-527-6266
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Participant must have histologically confirmed invasive breast cancer that is hormone receptor (HR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative according to the American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (Estrogen Receptor (ER) and progesterone receptor (PR) \< 1% and HER2 negative by immuno-histochemistry (IHC) and/or fluorescent in situ hybridization \[FISH\]
Participant must have evaluable disease as defined by the investigator using CT, MRI, or positron emission tomography (PET) scan
Participant must have refractory disease and failed, not tolerated, or progressed on at least two lines of prior standard therapeutic regimens for mTNBC.
Participant must be a woman of 22 years of age or older.
Participant must have a life expectancy of at least three months
Participant must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2
It is unknown 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 and male participants should avoid impregnating a female partner and donating sperm starting at initiation of treatment up until at least 12 weeks after treatment discontinuation
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 from sexual intercourse 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 child-bearing potential, agree to use at least one highly effective AND at least one additional method of contraception. Withdrawal is not an acceptable contraceptive method.

Exclusion

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 with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain magnetic resonance imaging (MRI) with and without contrast within 8 weeks of signing consent.
Participants who are taking any other investigational drugs
Participants who 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 who plan to receive calcium channel blockers and any agent blocking L-type of T-type voltage gated calcium channels (for example: amlodipine, nifedipine, ethosuximide, supplemental vitamin C/ascorbic acid, etc.) unless their medical treatment is discontinued prior to treatment. Participant must agree to abstain from using calcium channel blockers for the duration of treatment on study
Participants who plan to receive anticancer therapy that blocks L-type or T-type voltage gated calcium channels (i.e., eribulin, rucaparib, or niraparib) as part of their third line treatment. Participants who have received eribulin, rucaparib, or niraparib as part of a previous line of therapy are eligible, provided there has been at least 14 days between the last date of treatment and the start of study treatment.
Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan
Participants with a known severe (e.g., anaphylactic) allergy to nickel

What this trial measures

  • 6 month Progression Free Survival (PFS6)6 months after start of treatment

    PFS is defined as the interval from treatment initiation to the date of disease progression of death from any cause, whichever occurs first. The treating investigator will determine disease progression. PFS6 will be calculated as the proportion of participants who are alive without progression at six months post-treatment initiation.