Status:
RECRUITING
A Study of the TheraBionic P1 Device in Breast Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Conditions:
Breast Cancer Stage I
Breast Cancer Stage II
Eligibility:
FEMALE
22+ years
Phase:
NA
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-stag...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT07218432
Start Date
October 1 2026
End Date
June 30 2028
Last Update
December 31 2025
Active Locations (1)
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1
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201