Published on October 20, 2025, the Barbara Ann Karmanos Cancer Institute has announced active recruitment for a clinical study involving the TheraBionic P1 Device in treating hormone receptor-positive, HER2-negative breast cancer across multiple stages.
This investigational device targets patients diagnosed with Stage I, II, and IIIA breast cancer, aiming to explore safety, efficacy, and potential therapeutic benefits for this patient population.
- What is the study about?
- Who is eligible?
- How does the TheraBionic P1 Device work?
- Frequently Asked Questions
- Summary and next steps
- Important disclaimer
- Full announcement
What is the study about?
The clinical trial sponsored by the Barbara Ann Karmanos Cancer Institute aims to assess the performance of the TheraBionic P1 Device in managing cases of hormone receptor-positive, HER2-negative breast cancer. The study covers breast cancer patients from Stage I to IIIA, examining how this device influences disease progression and overall outcomes.
TheraBionic P1 is a medical device under investigation that uses electromagnetic-based therapy, giving hope for an innovative treatment pathway compared to conventional options. Research is aligned with modern practices ensuring patient safety and regulatory compliance under structured protocols.
Who is eligible?
The study targets female patients diagnosed with the following specific conditions:
- Stage I breast cancer
- Stage II breast cancer
- Stage IIIA breast cancer
- Hormone receptor-positive tumors
- HER2-negative breast cancer
Enrolled participants must meet inclusion criteria outlined in the study documentation and will undergo assessments to determine if this intervention is suitable.
How does the TheraBionic P1 Device work?
The TheraBionic P1 Device delivers low-energy electromagnetic fields aimed at targeting cancer cells. Its mechanism of action involves disrupting cellular activity associated with tumor growth, although deeper insights into efficacy will emerge as clinical data becomes available.
The Barbara Ann Karmanos Cancer Institute has asserted this device is being studied under tightly regulated conditions consistent with medical research standards.
Frequently Asked Questions
- What is hormone receptor-positive breast cancer?
It refers to breast cancer cells that rely on certain hormones, like estrogen or progesterone, for growth. Hormone receptor-positive cancers may respond to therapies targeting these receptors. - Will this study lead to FDA approval?
The study is a clinical investigation. If successful, future regulatory submissions may aim for FDA clearance or approval. - How can I enroll?
Individuals interested in participating can review additional criteria and contact the Barbara Ann Karmanos Cancer Institute through the linked clinical trial page below.
Summary and next steps
This study represents a crucial opportunity for patients and researchers to evaluate the TheraBionic P1 Device as a treatment option for hormone receptor-positive, HER2-negative breast cancer. The research outcomes could inform medical device progress and treatment pathways for solid tumors.
Healthcare teams and regulatory professionals should monitor updates from this trial to understand implications for future oncology care.
Important disclaimer
This content is for informational purposes and is not legal advice. Researchers and clinicians should consult specific regulatory guidance regarding medical devices.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07218432?term=medical+device