NCT02596867终止2 期
Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer
Texas Tech University Health Sciences Center, El Paso1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
研究概览
简要总结
This trial is a Phase II study using the "window-of-opportunity" design in which the treatment-free window between breast cancer diagnosis and surgical tumor resection is used to study the biological effects of the beta blocker propranolol .
详细描述
- Patients will be recruited from the Garbar Breast Care Center and University Medical Center following diagnosis of invasive breast cancer by breast biopsy.
- The sympatholytic nonselective beta blocker propranolol will be administered to all participants in a non-randomized manner at an equal dose of 1.5 mg/kg/day.
- Following surgical resection of the tumor , the primary endpoint of this study is quantified by comparing the proliferative index of the tumor before propranolol administration (quantified using the initial tumor biopsy) and after 3 weeks of propranolol (quantified using the surgically resected tumor).
- Additional molecular analyses and evaluation of safety and toxicity will also be performed to better understand the effects of this treatment on breast cancers and patient adherence to the drug.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ages 18- 65
- •diagnosis of stage I-III breast cancer , confirmed by a core biopsy
- •Planning to undergo definitive surgery including mastectomy or breast conserving surgery
- •Systolic blood pressure must be >100 mmHg but no more than 140 mmHg and/or diastolic > 60 mmHg and no more than 95 mmHg.
- •normal baseline EKG
- •Exclusion criteria:
- •Pregnancy; potential subjects of female bearing age will have to complete a pregnancy test during screening to ensure that they are not pregnant. Potential patients who are post-menopausal must have confirmed one year without menstrual cycle.
- •Free of major medical illnesses including:
- •Uncontrolled Diabetes (HbA1c of ≤ 8 if previously tested)
- •Uncontrolled hypertension: BP >systolic 140/ diastolic > 95
- •Cardiac diseases (history of cardiac valve disease, coronary artery disease, congestive heart failure, A-V block, peripheral vascular disease, any cardiac arrhythmia/bradycardia) with the exception of the diagnosed cancer.
- •Histories of asthma, bronchospastic disease, or obstructive pulmonary disease
- •Previously diagnosed thyrotoxicosis
- •Severe allergic reactions to medications which are included in the beta blocker family
- •Previously or currently treated with a beta adrenergic receptor antagonist
- •Patients with locally advanced or inflammatory breast cancer not amenable to surgical resection
- •Patients taking any of the following medications will be excluded:
- •Drugs that are categorized as digitalis glycosides, beta-blockers and calcium channel blockers, ACE inhibitors and alpha blockers
- •Amiodarone
- •Cimetidine
- •Ciprofloxacin
- •Delavudin
- •Dobutamine
- •Fluconazole
- •Fluoxetine
- •Fluvoxamine
- •Haloperidol
- •Imipramine
- •Isoniazid
- •Isoproterenol
- •Luvoxamine
- •Paroxetine
- •Phenytoin
- •Phenobarbital.
- •Propafenone.
- •Quinidine
- •Reserpine
- •Ritonavir
- •Rizatriptan.
- •Tenioposide
- •Theophylline
- •Thyroxine
- •Tolbutamide.
- •Zolmitriptan
排除标准
- 未提供
研究组 & 干预措施
open label single arm, drug propanolol
Experimental
all subjects will receive the experimental drug
干预措施: propanolol (Drug)
结局指标
主要结局
Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
时间窗: 3 weeks
to evaluate effect of beta adrenergic blockades on breast cancer at by Ki67 percentage change- we are looking at at least 10% mean change in the tumor proliferative index following propranolol treatment
次要结局
- Assess the Safety, Toxicity and Adherence to Propranolol.(3 weeks)
研究者
Zeina Nahleh
Professor
Texas Tech University Health Sciences Center, El Paso
研究点 (1)
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