NCT07218432招募中不适用
A Window of Opportunity Pilot Study: TheraBionic P1 Device for Patients With Resectable Early-stage Breast Cancer in a Neoadjuvant Setting
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 9
- 主要终点
- Pathological Response to Treatment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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-
- •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
排除标准
- •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.
研究组 & 干预措施
TheraBionic P1 device
Experimental
Self Administered Amplitude-modulated electromagnetic fields three times daily
干预措施: TheraBionic P1 Device (Device)
结局指标
主要结局
Pathological Response to Treatment
时间窗: At time of surgery (after approximately 2 weeks of treatment and tumor resection)
Proportion of responders based on residual cancer cells in a resection specimen will be quantified. The response rate will be estimated as the proportion of patients who respond to treatment relative to all patients. The corresponding two-sided 95% confidence interval (CI) will be calculated using Clopper and Pearson's method
次要结局
- Changes in microRNA expression in tumor tissue(Baseline to post-surgical resection)
- Changes in Ki-67 expression in tumor tissue(Baseline to post-surgical resection)
- Changes in tumor apoptosis marker Cleaved caspase-3 (CC3) in tumor tissue(Baseline to post-surgical resection)
- Changes in cell cycle arrest marker p27 in tumor tissue(Baseline to post-surgical resection)
- Progression Free Survival (PFS)(Up to 5 years post-surgery)
- Overall survival (OS)(Up to 5 years post-surgery)
研究者
Lubina Arjyal MD
Principal Investigator
Barbara Ann Karmanos Cancer Institute
研究点 (9)
Loading locations...
相似试验
招募中
2 期
Amplitude-Modulated Radiofrequency Electromagnetic Fields (AM RF EMF) in Combination With Fruquintinib in Refractory Metastatic Colorectal CancerNCT07130903Barbara Ann Karmanos Cancer Institute102
进行中（未招募）
2 期
Phase 2 Trial of Adaptive Radiotherapy Boost for HNSCCHead and Neck CancerSquamous Cell CarcinomaNCT06137274H. Lee Moffitt Cancer Center and Research Institute25
招募中
不适用
Efficacy of Non-ablative Radiofrequency Combined With Pelvic Floor Muscle Training for Genitourinary Syndrome of Menopause in Breast Cancer Survivors (RF-SGM)Breast CancerNCT07034976Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal50
撤回
4 期
The PRIORi-T Trial--Prospective Randomized Investigation of Radiofrequency Targeted Vertebral AugmentationPainful Osteoporotic Vertebral Compression Fractures (VCF)NCT01480167DFINE Inc.
招募中
不适用
Early Feasibility Clinical Investigation to Assess YntraDose™ as a Neoadjuvant Treatment for LA-PDACNCT07155850BetaGlue Therapeutics SpA10