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New treatment option for Breast Cancer Stage I
Official title A Study of the TheraBionic P1 Device in Breast Cancer
ClinicalTrials.gov ID: NCT07218432
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only
You may be able to join if
- Participant must have histologically proven invasive breast cancer that is HR (hormone receptor) positive and HER2 (Human Epidermal Growth Factor...
- 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
You likely can't join 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 how...
- 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...
- Participants with active oral mucosal inflammation, ulceration, or other pathology that could interfere with the use of TheraBionic P1 device (for...
- Participants receiving calcium channel blockers and any agent blocking L-type or T-type voltage gated calcium channels (for example: amlodipine...
See the full eligibility 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...
- 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...
- 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 how well it works 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Clarkston, Michigan, United States
- Detroit, Michigan, United States
- Farmington Hills, Michigan, United States
- Flint, Michigan, United States
- Lansing, Michigan, United States
- Lapeer, Michigan, United States
- Petoskey, Michigan, United States
- Port Huron, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clarkston, Michigan, United States; Detroit, Michigan, United States; Farmington Hills, Michigan, United States; Flint, Michigan, United States; Lansing, Michigan, United States; Lapeer, Michigan, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.