No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
22 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
24 (estimated)
Sponsor
Barbara Ann Karmanos Cancer Institute · Other
Who this trial is looking for
This trial is looking for women with certain types of breast cancer to see if a special device helps improve treatment outcomes. Participants will receive two weeks of therapy before having surgery.
Are You a Good Fit for This Trial?
Must not be takingCalcium channel blockers
You may be able to join if
I have been diagnosed with hormone receptor positive, HER2 negative breast cancer.
I have early-stage breast cancer that can be treated with surgery.
I am available for at least two weeks of TheraBionic treatment before my surgery.
I have past tissue samples available for testing.
I am a woman aged 22 years or older.
I can understand and sign a consent form.
I have an ECOG performance status of 0-2.
I will avoid pregnancy during treatment and for 30 days after.
You may not be able to join if
I am receiving or will receive chemotherapy or hormonal therapy before surgery.
I have an active secondary cancer that could affect my treatment.
I am taking any other investigational drugs.
I am pregnant or breastfeeding.
I have oral infections or wounds that could interfere with device use.
I am taking calcium channel blockers.
I cannot follow the study protocol or cannot use the device.
I have a severe allergy to nickel.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
Eligibility Criteria
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) guid…
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.
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