A window of opportunity pilot study: TheraBionic P1 device for patients with resectable early-stage breast cancer in a neoadjuvant setting

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

To descriptively summarize the pathological response of breast cancer to shortterm use of breast cancer-specific AM RF EMF therapy, delivered using the TheraBionic P1 device in patients with resectable early-stage breast cancer in the neoadjuvant setting

Secondary Objectives:

To evaluate long term outcomes
To explore the effects of short-term delivery of breast cancer-specific AM RF EMF therapy on markers of breast tumor proliferation, apoptosis, and cell cycle arrest in pathological specimens

Eligibility

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices