TheraBionic P1 Device for HER2-negative Breast Cancer

A Study of the TheraBionic P1 Device in Breast Cancer

Recruiting N/A Interventional Study
Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Hormone Receptor Positive Tumor HER2-negative Breast Cancer
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 taking Calcium 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.

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About This Trial

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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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…
Contacts

Lubina Arjyal, M.D.

1-800-karmanos

arjyall@karmanos.org

CONTACT