NCT03122444已完成早期 1 期
A Pre-Surgical Window of Opportunity Trial Investigating the Effect of Imipramine on Previously Untreated Breast Cancer (CTMS# 17-0037)
The University of Texas Health Science Center at San Antonio1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年7月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Decrease in the proliferation rate of triple negative breast cancer
研究概览
简要总结
Comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.
详细描述
This will be a single arm, non-randomized, pre-surgical clinical trial of women with newly diagnosed triple negative breast cancer comparing changes in biomarkers from a diagnostic core needle biopsy to surgical pathology specimen or repeat core needle biopsy.
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
- 18 Years 至 71 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants may be female or male who are 18 years old or older.
- •Ability to consent to treatment - patients or their legally authorized representative must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
- •Previously untreated breast cancer determined by a core needle biopsy showing invasive ductal carcinoma or invasive lobular carcinoma.
- •A prior, unrelated, breast cancer is allowed.
- •All breast cancers with possibility for surgical excision will be included.
- •Patient must be able to take oral medications. Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of the study drug.
- •Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 14 days prior to the first dose of imipramine.
- •Patients must be eligible for surgical resection of their breast cancer or repeat biopsy after completing treatment.
- •Patients must have a complete history and physical examination within 30 days prior to registration.
- •Patients must have a performance status of ECOG 0, 1,
- •Tissue block of initial biopsy specimen is available.
- •Patient may not be concurrently enrolled in another investigational drug treatment study.
排除标准
- •Known diagnosis of major depressive disorder, bipolar depression or psychosis
- •ECOG 3 or 4
- •Age >= 70 years
- •Renal impairment defined as EGFR <30
- •Hepatic impairment as judged by clinical investigator or bilirubin >2
- •As judged by the investigator, severe uncontrolled concurrent medical conditions, psychiatric illness or social condition that would limit compliance with study requirements
- •History of cardiac disease (arrhythmia, conduction abnormality, congenital prolonged QT syndrome, or prolonged QTc rhythm noted during initial EKG >480 ms)
- •Current use of SSRI, SNRI, MAO inhibitor, tramadol or trazadone; or use of these agents within 14 days
- •Inflammatory breast cancer
- •Suicidal ideation or history of suicide attempt
- •Myocardial infarction within 3 months of study initiation.
- •Patients with Angle-Closure Glaucoma
- •Pregnant or breast-feeding women. As there have been no well-controlled studies conducted with pregnant women to determine the effect of imipramine on the fetus. However, there have been clinical reports of congenital malformations associated with the use of the drug.
研究组 & 干预措施
Imipramine
Experimental
Imipramine will initially be 50mg and this will be increased by 50mg every other day as tolerated to 200 mg.
干预措施: Imipramine (Drug)
结局指标
主要结局
Decrease in the proliferation rate of triple negative breast cancer
时间窗: 30 days
次要结局
未报告次要终点
研究者
Virginia G. Kaklamani
Principal Investigator
The University of Texas Health Science Center at San Antonio
研究点 (1)
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