Actively Recruiting
A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2026-04-21
24
Participants Needed
8
Research Sites
61 weeks
Total Duration
On this page
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 treatment's impact before surgery in a neoadjuvant setting. Participants will self-administer the TheraBionic P1 device therapy three times a day for 60 minutes each session—morning, midday, and evening—over 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
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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 2 weeks
Participants self-administer the TheraBionic P1 device with three 60-minute treatments per day before surgical tumor resection.
Daily use of device at home prior to surgery
Duration - Surgery day and immediate recovery
Participants undergo surgical resection of early-stage breast cancer after device treatment.
1 surgical procedure visit
Duration - Up to 5 years
Participants are monitored for overall survival and progression-free survival outcomes up to 5 years after surgery.
Periodic follow-up visits for up to 5 years
Trial Site Locations
Total: 8 locations
1
Karmanos Cancer Institute at McLaren Clarkston
Clarkston, Michigan, United States, 48346
Actively Recruiting
2
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Actively Recruiting
3
Karmanos Cancer Institute Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Actively Recruiting
4
Karmanos Cancer Institute at McLaren Flint
Flint, Michigan, United States, 48532
Actively Recruiting
5
Karmanos Cancer Institute at McLaren Greater Lansing
Lansing, Michigan, United States, 48910
Actively Recruiting
6
Karmanos Cancer Institute at McLaren Lapeer Region
Lapeer, Michigan, United States, 48466
Actively Recruiting
7
Karmanos Cancer Institute at McLaren Northern Michigan
Petoskey, Michigan, United States, 49770
Actively Recruiting
8
Karmanos Cancer Institute at McLaren Port Huron
Port Huron, Michigan, United States, 48060
Actively Recruiting
Research Team
L
Lubina Arjyal, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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