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A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer

A Phase 2 Study of TheraBionic P1 Device for Patients With Metastatic Hormone Positive Breast Cancer Post Endocrine Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
22 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the TheraBionic P1 device in women with advanced breast cancer that is hormone receptor positive (HR+) and HER2 negative. It is for women whose cancer got worse on standard treatments or who could not tolerate them. The study will check safety, how the cancer responds, and whether the device helps women live longer or longer without cancer getting worse.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have breast cancer that has spread nearby and cannot be removed by surgery, or has spread to other parts of the body. Tests must show HR+ (hormones help it grow) and HER2 negative (no high level of the HER2 protein).
  • Have tried all treatments known to help people live longer, with cancer getting worse or side effects you could not tolerate. These must include hormone therapy with a CDK4/6 blocker (a drug that slows cancer growth), plus chemotherapy or an antibody-drug treatment that carries cancer-killing medicine.
  • Be a woman age 22 or older who can understand and sign a study consent form.
  • Be expected to live at least 3 months.
  • Have an ECOG activity score of 0–2: be able to care for yourself and be out of bed or a chair for more than half the day.
  • If you can become pregnant, agree to avoid pregnancy from the start of treatment until at least 30 days after the last device session.
  • Meet a pregnancy prevention rule: have had surgery that prevents pregnancy; have had no periods for at least 12 months due to menopause; have no sex as your usual lifestyle; be in a relationship where pregnancy cannot happen; or use at least one birth control method. Tracking fertile days and withdrawal do not count.

Who can't join

  • Have another active cancer, unless the study doctor thinks it is unlikely to affect study safety or results.
  • Take another drug being tested in research.
  • Be pregnant or breastfeeding. You must stop breastfeeding to join.
  • Have mouth swelling, sores, infection, bleeding, or another mouth problem that could prevent device use.
  • Take calcium channel blockers or other medicines that block certain calcium channels, such as amlodipine, nifedipine, ethosuximide, or vitamin C, unless stopped at least one day before treatment. You must avoid them throughout study treatment.
  • Be unwilling to follow the study's follow-up plan, or have thinking or physical problems that prevent device use.
  • Have a known severe allergy to nickel.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (8)

MI