A Study of the TheraBionic P1 Device in Breast Cancer

Официальное название

A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting

Обзор

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.

Вмешательства

• Устройство TheraBionic P1 Device
  Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three 60-minute treatments per day, administered in the morning, middle of the day and in the evening prior to surgical resection of early stage breast cancer.

Первичные конечные точки

• Pathological Response to Treatment [Срок оценки: At time of surgery (after approximately 2 weeks of treatment and tumor resection)]

Вторичные конечные точки (6)

• Changes in microRNA expression in tumor tissue [Срок оценки: Baseline to post-surgical resection]
• Changes in Ki-67 expression in tumor tissue [Срок оценки: Baseline to post-surgical resection]
• Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue [Срок оценки: Baseline to post-surgical resection]
• Changes in cell cycle arrest marker p27 in tumor tissue [Срок оценки: Baseline to post-surgical resection]
• Overall survival (OS) [Срок оценки: Up to 5 years post-surgery]
• Progression Free Survival (PFS) [Срок оценки: Up to 5 years post-surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• Karmanos Cancer Institute at McLaren Clarkston — Clarkston
• Karmanos Cancer Institute — Detroit
• Karmanos Cancer Institute Weisberg Cancer Treatment Center — Farmington Hills
• Karmanos Cancer Institute at McLaren Flint — Flint
• Karmanos Cancer Institute at McLaren Greater Lansing — Lansing
• Karmanos Cancer Institute at McLaren Lapeer Region — Lapeer
• Karmanos Cancer Institute at McLaren Northern Michigan — Petoskey
• Karmanos Cancer Institute at McLaren Port Huron — Port Huron

Идентификаторы

NCT: NCT07218432 · 2025-026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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