NCT07218432 A Study of the TheraBionic P1 Device in Breast Cancer
| NCT ID | NCT07218432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Barbara Ann Karmanos Cancer Institute |
| Condition | Breast Cancer Stage I |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-10 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 24 participants in total. It began in 2026-10 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.
Eligibility Criteria
Inclusion Criteria: * Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor Receptor 2) negative according to the 2010 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines (ER and/or PR (progesterone receptor) \>1% and HER2 negative by immunohistochemistry \[IHC\] and/or fluorescent in situ hybridization \[FISH\]). * Participant must have early-stage operable disease (stage I-II or III who have planned upfront surgery) and agree to definitive upfront surgery. * Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled resection * Participant must have archival tissue available. * Participant must be a woman aged 22 years or older * Participant must be able to understand a written informed consent document and be willing to sign it * Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status 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 child-bearing potential must agree to avoid becoming pregnant starting at initiation of treatment up until at least 30 days after the last TheraBionic P1 session Exclusion Criteria: * Participants that are receiving or will receive neoadjuvant chemotherapy or neoadjuvant hormonal therapy * 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 due to the unknown but potential risk for adverse events. 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.
Contact & Investigator
Lubina Arjyal, M.D.
PRINCIPAL INVESTIGATOR
Wayne State University
Frequently Asked Questions
Who can join the NCT07218432 clinical trial?
This trial is open to female participants only, aged 22 Years or older, studying Breast Cancer Stage I. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07218432 currently recruiting?
Yes, NCT07218432 is actively recruiting participants. Contact the research team at arjyall@karmanos.org for enrollment information.
Where is the NCT07218432 trial being conducted?
This trial is being conducted at Clarkston, United States, Detroit, United States, Farmington Hills, United States, Flint, United States and 4 additional locations.
Who is sponsoring the NCT07218432 clinical trial?
NCT07218432 is sponsored by Barbara Ann Karmanos Cancer Institute. The principal investigator is Lubina Arjyal, M.D. at Wayne State University. The trial plans to enroll 24 participants.
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