A Study of the TheraBionic P1 Device in Breast Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorBarbara Ann Karmanos Cancer Institute

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • TheraBionic P1 Device

Treatment groups

24 Participants
are divided into 1 treatment group