Recruiting

TheraBionic P1A Study of the TheraBionic P1 Device in Breast Cancer

Sponsor:

Barbara Ann Karmanos Cancer Institute

Code:

NCT07218432

Conditions

Breast Cancer Stage I

Breast Cancer Stage II

Breast Cancer Stage IIIA

Hormone Receptor Positive Tumor

HER2-negative Breast Cancer

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

Interventions

TheraBionic P1 Device

Study Details

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 I

Breast Cancer Stage II

Breast Cancer Stage IIIA

Hormone Receptor Positive Tumor

HER2-negative Breast Cancer

Study ID

NCT07218432

Start date

Oct, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Apr 30, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 22+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TheraBionic P1 device

Self Administered Amplitude-modulated electromagnetic fields three times daily

Interventions

TheraBionic P1 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.

Primary outcome measure

Pathological Response to Treatment [ Time Frame: At time of surgery (after approximately 2 weeks of treatment and tumor resection) ]

Central Contacts and Locations

Central contacts

Lubina Arjyal, M.D.

1-800-karmanos arjyall@karmanos.org

Locations

Karmanos Cancer Institute at McLaren Clarkston

Recruiting

Clarkston, Michigan, United States, 48346

Contacts

248-922-6650

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Lubina Arjyal, MD

1-800-527-6266 arjyall@karmanos.org

Karmanos Cancer Institute Weisberg Cancer Treatment Center

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

1-800-527-6266

Karmanos Cancer Institute at McLaren Flint

Recruiting

Flint, Michigan, United States, 48532

Contacts

810-342-3800

Karmanos Cancer Institute at McLaren Greater Lansing

Recruiting

Lansing, Michigan, United States, 48910

Contacts

517-975-9500

Karmanos Cancer Institute at McLaren Lapeer Region

Recruiting

Lapeer, Michigan, United States, 48466

Contacts

810-667-4994

Karmanos Cancer Institute at McLaren Northern Michigan

Recruiting

Petoskey, Michigan, United States, 49770

Contacts

231-487-3390

Karmanos Cancer Institute at McLaren Port Huron

Recruiting

Port Huron, Michigan, United States, 48060

Contacts

810-982-5200

More Information

Sponsor

Barbara Ann Karmanos Cancer Institute

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute on 2026-04-21.