Recruiting

TheraBionic P1

Sponsor:

Barbara Ann Karmanos Cancer Institute

Code:

NCT07227831

Conditions

HER2-negative Breast Cancer

Hormone Receptor Positive Tumor

Advanced Breast Cancer

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

TheraBionic P1

Study Details

Brief summary:

The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are:

  • will the TheraBionic P1 device affect progression free and overall survival in advanced or metastatic HR positive, HER2 negative breast cancer
  • the long term safety and tolerability of the TheraBionic P1 device
  • assessment of how the disease responded to the TheraBionic P1 device

Conditions

HER2-negative Breast Cancer

Hormone Receptor Positive Tumor

Advanced Breast Cancer

Metastatic Breast Cancer

Study ID

NCT07227831

Start date

Jan 16, 2026

Status verified date

Aug, 2026

Completion date

May 22, 2028

Anticipated

Primary completion date

May 22, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

82 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TheraBionic P1 device

Self administered Amplitude-modulated electromagnetic fields three times daily

Interventions

TheraBionic P1

Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day, and in the evening

Primary outcome measure

  • Progression Free Survival (PFS) [ Time Frame: From start of treatment to 5 years after treatment discontinuation or death, whichever comes first ]

Central Contacts and Locations

Central contacts

Hadeel Assad, M.D.

1-800-527-6266Assadh@karmanos.org

Locations

Karmanos Cancer Institute at McLaren Bay Region

Recruiting

Bay City, Michigan, United States, 48706

Contacts

989-667-2370

Karmanos Cancer Institute at McLaren Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

248-922-6650

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Hadeel Assad, MD

18005276266

Karmanos Cancer Institute at McLaren Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

1-810-342-3800

Karmanos Cancer Institute at McLaren Lapeer Region

Recruiting

Lapeer, Michigan, United States, 48446

Contacts

1-810-667-4994

Karmanos Cancer Institute at McLaren Macomb

Recruiting

Mount Clemens, Michigan, United States, 48043

Contacts

1-586-493-7510

Karmanos Cancer Institute at McLaren Northern

Recruiting

Petoskey, Michigan, United States, 49770

Contacts

231-487-3390

Karmanos Cancer Institute at McLaren Port Huron

Recruiting

Port Huron, Michigan, United States, 48060

Contacts

1-810-982-5200

More Information

Sponsor

Barbara Ann Karmanos Cancer Institute

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • therabionic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute on 2026-08-26.