A Study of the TheraBionic P1 Device in Breast Cancer

NCT07218432 | Recruiting FDA Device

• 1 other identifier: 2025-026
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 8

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.

Conditions

Breast Cancer Stage II; Breast Cancer Stage IIIA; Hormone Receptor Positive Tumor; HER2-negative Breast Cancer; Breast Cancer Stage I

Outcome Measures

Primary Outcomes (1)

• Pathological Response to Treatment

  Proportion of responders based on residual cancer cells in a resection specimen will be quantified. The response rate will be estimated as the proportion of patients who respond to treatment relative to all patients. The corresponding two-sided 95% confidence interval (CI) will be calculated using Clopper and Pearson's method

  At time of surgery (after approximately 2 weeks of treatment and tumor resection)

Secondary Outcomes (6)

• Changes in microRNA expression in tumor tissue

  Baseline to post-surgical resection

• Changes in Ki-67 expression in tumor tissue

  Baseline to post-surgical resection

• Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue

  Baseline to post-surgical resection

• Changes in cell cycle arrest marker p27 in tumor tissue

  Baseline to post-surgical resection

• Overall survival (OS)

  Up to 5 years post-surgery

Other Outcomes (1)

• Positron Emission Tomography with 3'-Deoxy-3'-18F-Fluorothymidine (PET-FLT) association of response to treatment

  From Screening to after 7 days of treatment with the TheraBionic Device.

Study Arms (1)

TheraBionic P1 device

EXPERIMENTAL

Self Administered Amplitude-modulated electromagnetic fields three times daily

Device: TheraBionic P1 Device

Interventions

TheraBionic P1 Device DEVICE

Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer.

TheraBionic P1 device

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (8)

Karmanos Cancer Institute at McLaren Clarkston

Clarkston, Michigan, 48346, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Farmington Hills, Michigan, 48334, United States

RECRUITING

Karmanos Cancer Institute at McLaren Flint

Flint, Michigan, 48532, United States

RECRUITING

Karmanos Cancer Institute at McLaren Greater Lansing

Lansing, Michigan, 48910, United States

RECRUITING

Karmanos Cancer Institute at McLaren Lapeer Region

Lapeer, Michigan, 48466, United States

RECRUITING

Karmanos Cancer Institute at McLaren Northern Michigan

Petoskey, Michigan, 49770, United States

RECRUITING

Karmanos Cancer Institute at McLaren Port Huron

Port Huron, Michigan, 48060, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lubina Arjyal, M.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lubina Arjyal, M.D.

CONTACT

1-800-karmanos; arjyall@karmanos.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 20, 2025
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (8)