Actively Recruiting
A Study of the TheraBionic P1 Device in Breast Cancer
Led by Barbara Ann Karmanos Cancer Institute · Updated on 2026-04-21
24
Participants Needed
8
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of the TheraBionic P1 Device in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Woman aged 22 years or older
- Histologically confirmed invasive breast cancer that is hormone receptor positive and HER2-negative
- Early-stage operable disease (stage I-II or III) with planned upfront surgery
- Available for at least two weeks of TheraBionic treatment before surgery
- Archival tissue available
- Able to understand and sign informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Women of childbearing potential agree to avoid pregnancy during treatment and for 30 days after last session
You will not qualify if you...
- Receiving or will receive neoadjuvant chemotherapy or hormonal therapy
- Known active secondary malignancy likely to interfere with study
- Taking other investigational drugs
- Pregnant or breastfeeding (breastfeeding must be discontinued to participate)
- Active oral mucosal inflammation, ulceration, or pathology interfering with device use
- Taking calcium channel blockers or agents blocking L-type or T-type voltage gated calcium channels unless discontinued one day prior and abstaining during study
- Not agreeing to study follow-up or unable to use the device due to cognitive or physical limitations
- Known severe allergy to nickel
AI-Screening
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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.
CONTACT
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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