Adding TheraBionic P1 radiofrequency therapy to treatment for early-stage HR+ HER2- breast cancer
A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
NA · Barbara Ann Karmanos Cancer Institute · NCT07218432
This study will try giving TheraBionic P1 amplitude-modulated radiofrequency therapy before surgery to see if it improves tumor response in women with early-stage, hormone receptor–positive, HER2-negative breast cancer.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 22 Years and up |
| Sex | Female |
| Sponsor | Barbara Ann Karmanos Cancer Institute (other) |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Clarkston, Michigan and 7 other locations) |
| Trial ID | NCT07218432 on ClinicalTrials.gov |
What this trial studies
Participants with operable early-stage, hormone receptor–positive, HER2-negative breast cancer will receive TheraBionic P1 amplitude-modulated radiofrequency electromagnetic field treatment for at least two weeks prior to their planned definitive surgery. The device therapy is added to standard clinical management with the main outcome being the pathological response measured at resection. The trial is interventional and conducted at multiple sites within the Karmanos Cancer Institute network in Michigan. Archival tumor tissue is required and patients must be able to provide informed consent.
Who should consider this trial
Good fit: Women aged 22 or older with histologically proven invasive, early-stage (stage I–II or selected stage III planned for upfront surgery) HR-positive, HER2-negative breast cancer who can undergo at least two weeks of device treatment and provide archival tissue.
Not a fit: Patients with HER2-positive or HR-negative tumors, metastatic disease, those not planning upfront surgery, or those unable to attend the treatment visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, adding this device before surgery could increase the amount of tumor killed prior to resection and reduce residual disease.
How similar studies have performed: Small pilot and early-phase studies of amplitude-modulated radiofrequency approaches have reported limited signals of activity, but device-specific evidence in early-stage breast cancer is sparse and not yet conclusive.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Clarkston, Michigan and 7 other locations
- Karmanos Cancer Institute at McLaren Clarkston — Clarkston, Michigan, United States (RECRUITING)
- Karmanos Cancer Institute — Detroit, Michigan, United States (RECRUITING)
- Karmanos Cancer Institute Weisberg Cancer Treatment Center — Farmington Hills, Michigan, United States (RECRUITING)
- Karmanos Cancer Institute at McLaren Flint — Flint, Michigan, United States (RECRUITING)
- Karmanos Cancer Institute at McLaren Greater Lansing — Lansing, Michigan, United States (RECRUITING)
- Karmanos Cancer Institute at McLaren Lapeer Region — Lapeer, Michigan, United States (RECRUITING)
- Karmanos Cancer Institute at McLaren Northern Michigan — Petoskey, Michigan, United States (RECRUITING)
- Karmanos Cancer Institute at McLaren Port Huron — Port Huron, Michigan, United States (RECRUITING)
Study contacts
- Principal investigator: Lubina Arjyal, M.D. — Wayne State University
- Study coordinator: Lubina Arjyal, M.D.
- Email: arjyall@karmanos.org
- Phone: 1-800-karmanos
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage IIIA, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer