What is the TheraBionic P1 device studying for early-stage breast cancer?

The TheraBionic P1 device is being studied to see if adding its cancer-specific electromagnetic field therapy before surgery affects the tumor's response in women with early-stage, hormone receptor-positive, HER2-negative breast cancer. This research aims to understand if this device changes tumor characteristics before removal and is led by the Barbara Ann Karmanos Cancer Institute.

Who may be eligible for this early-stage breast cancer clinical trial?

Women aged 22 or older with hormone receptor-positive, HER2-negative invasive breast cancer scheduled for upfront surgery may be eligible. Participants must not be receiving neoadjuvant chemotherapy or hormonal therapy and should have no active oral mucosal issues or allergies to nickel. Please review eligibility criteria for more details.

Is there any cost to participate in this early-stage breast cancer clinical trial?

Study-related care, including the use of the TheraBionic P1 device and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and might not be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

Age: 22Years +

FEMALE

ID07218432

Pilot Study of the TheraBionic P1 Device for Women with Early-Stage Resectable Breast Cancer Using Neoadjuvant Amplitude-Modulated Electromagnetic Field Therapy

Led by Barbara Ann Karmanos Cancer Institute · Updated on 2026-04-21

Participants Needed

Research Sites

61 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating whether adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy using the TheraBionic P1 device can affect the pathological response in patients with resectable early-stage breast cancer. This study focuses on women with hormone receptor-positive, HER2-negative breast cancer who are planning upfront surgery. The research is designed to evaluate the treatments impact before surgery in a neoadjuvant setting. Participants will self-administer the TheraBionic P1 device therapy three times a day for 60 minutes each sessionmorning, midday, and eveningover approximately two weeks before their scheduled tumor resection surgery. This device delivers amplitude-modulated electromagnetic fields continuously during these sessions. The study does not include a comparison group or blinding. During the trial, participants will have their tumor tissue evaluated for pathological response at the time of surgery. Researchers will also analyze changes in microRNA, Ki-67, tumor apoptosis marker Cleaved caspase-3, and cell cycle arrest marker p27 from baseline to post-surgical tissue. Long-term follow-up will assess overall survival and progression-free survival for up to five years after surgery. Participants will be monitored for safety and treatment adherence throughout the study period.

CONDITIONS

Brief Title

A Study of the TheraBionic P1 Device in Breast Cancer

Who Can Participate

Age: 22Years +

FEMALE

Eligibility Criteria

You may qualify if you...

Participant must have histologically proven invasive breast cancer that is hormone receptor positive and HER2 negative as per 2010 ASCO CAP guidelines (ER and/or PR >1% and HER2 negative by IHC and/or FISH).
Participant must have early-stage operable disease (stage I-II or III) with planned upfront surgery and agree to definitive upfront surgery.
Participant must be available for at least two weeks of TheraBionic treatment prior to scheduled tumor resection.
Participant must have archival tissue available.
Participant must be a woman aged 22 years or older.
Participant must be able to understand and willing to sign written informed consent.
Participant must have ECOG performance status of 0-2.
Women of child-bearing potential must agree to avoid pregnancy from treatment start until at least 30 days after last TheraBionic session.

You will not qualify if you...

Receiving or planning to receive neoadjuvant chemotherapy or hormonal therapy.
Known active secondary malignancy unless unlikely to affect safety or study endpoints.
Taking any other investigational drugs.
Pregnant or breastfeeding; breastfeeding must be discontinued to participate.
Active oral mucosal inflammation, ulceration, or other oral pathology interfering with device use.
Receiving calcium channel blockers or agents blocking L-type or T-type voltage gated calcium channels unless discontinued at least one day before treatment; must abstain during study.
Unable or unwilling to follow study protocol or use the device due to cognitive or physical inability.
Known severe allergy to nickel.

Research Team

Lubina Arjyal, M.D.

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Pilot Study of the TheraBionic P1 Device for Women with Early-Stage Resectable Breast Cancer Using Neoadjuvant Amplitude-Modulated Electromagnetic Field Therapy

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria