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Triple Negative Breast CancerNCT07672431

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

A study testing TheraBionic P1 in people with Triple Negative Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if adding the TheraBionic P1 device to standard of care third line treatment for adult women with metastatic triple negative breast cancer (mTNBC) who have failed, not tolerated, or progressed on standard first- and second-line treatment options can work better than the… Read more about this study

Who is it for?
Ages 22 years and older, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
TheraBionic P1
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Sep 2026to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 have a washout period of at least 14 days between the last line of treatment and the start of study treatment.
  • Participant must be a woman of 22 years of age or older.
  • Participant must have a life expectancy of at least three months
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jailan Elayoubi, M.D. contact

1-800-527-6266

elayoubij@karmanos.org

United States1 site

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Jailan Elayoubi, M.D., 1-800-527-6266

Other trials in United States

About this study

Official title: A Pilot Study of the Efficacy of the TheraBionic P1 Device in Patients With Metastatic Triple Negative Breast Cancer in the Third-line Setting

The goal of this clinical trial is to learn if adding the TheraBionic P1 device to standard of care third line treatment for adult women with metastatic triple negative breast cancer (mTNBC) who have failed, not tolerated, or progressed on standard first- and second-line treatment options can work better than the standard of care alone. The main questions it aims to answer is:

  • will the addition of the TheraBionic P1 device to standard of care third line treatment affect progression free and overall survival in these participants
Being tested
TheraBionic P1
Keywords
mTNBC
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TheraBionic P1Device

    TheraBionic P1 is amplitude-modulated radiofrequency electromagnetic fields (AM RF EMF) device added to any third line treatment for triple negative breast cancer

Study groups in NCT07672431
Study groupRoleWhat they receive
Amplitude-modulated radiofrequency electromagnetic fields device plus third line treatmentExperimentalTheraBionic P1 amplitude-modulated radiofrequency electromagnetic fields device 3 times daily (continuous) plus standard of care third line treatment
Receives: Device: TheraBionic P1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 month Progression Free Survival (PFS6)

    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.

    Measured: 6 months after start of treatment

Secondary outcomes (3)

  1. Changes in Quality of Life Scores (QOL)

    QOL scores are evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ - C30). It is 30-item questionnaire assessing cancer patients' health-related quality of life, covering functional scales (physical, role, emotional, cognitive, social), symptom scales (fatigue, pain, nausea, dyspnoea, etc.), and a global health/QoL scale. We will record the time to deterioration of QOL, physical functioning, and role functioning, as reported by the participant, with deterioration defined as a decrease from baseline of 10 points or more on the EORTC QLQ - C30 maintained for two consecutive assessments or a decrease of 10 points or more in one assessment followed by death from any cause within three weeks.

    Measured: From baseline to up to 1 year after treatment initiation

  2. Overall Survival (OS)

    Participants will be followed for survival status every six months for five years after treatment is initiated. OS is defined as the interval from treatment initiation to the date of death from any cause. The distribution of time-to-event data (OS) will be graphically summarized using a Kaplan-Meier (KM) curve, with corresponding median and two-sided 95% Confidence Level (CI) computed using KM estimates. OS rates every six months post-treatment will be estimated using KM estimates with two-sided 95% CIs provided for each time point.

    Measured: From baseline to up to 5 years after treatment initiation

  3. Progression Free Survival

    Participants will be followed for progression status every six months for five years after treatment is initiated. Participants will not be followed for progression if they start another anti-cancer therapy during this time. 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. The distribution of time-to-event data (PFS) will be graphically summarized using a Kaplan-Meier (KM) curve, with corresponding median and two-sided 95% CI computed using KM estimates. PFS rates every six months post-treatment will be estimated using KM estimates with two-sided 95% CIs provided for each time point.

    Measured: From baseline to up to 5 years after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2026
  2. Study startSep 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07672431
Sponsor's protocol ID
2025-103
Status last verified
Jun 2026
First submitted
19 Jun 2026
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing TheraBionic P1 in people with Triple Negative Breast Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jailan Elayoubi, M.D. (1-800-527-6266, elayoubij@karmanos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 month Progression Free Survival (PFS6) (time frame: 6 months after start of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07672431.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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