EUCTR2010-018795-24-FR进行中（未招募）不适用
Evaluation of the effect of pasireotide LAR administration in the lymphocele prevention after axillary node dissection for breast cancer - SOM 230
Alliance pour la recherche en cancérologie0 个研究点开始时间: 2010年2月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Female patient aged 18 years or over.
- •-Patient understands French.
- •-Patient covered by the French national health insurance system.
- •-Any female patient scheduled for breast surgery with mastectomy and axillary node dissection indicated at the pre-surgical stage.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patient under the age of 18 years.
- •-Patient who does not understand French.
- •-Patient not covered by the French national health insurance system.
- •-Patient exhibiting one or more contraindications to anesthesia and surgery.
- •-Patient with a contra-indication to pasireotide
- •-Refusal by the patient
- •-Scheduled sentinel node procedure
- •-Abnormal coagulation or curative anticoagulant treatment
- •-Women of child-bearing potential without effective contraception,
- •-Pregnant or breast-feeding women
- •-Poorly controlled diabetes (HbA1c > 8%)
- •-History of radiotherapy
- •-Recurrent breast cancer
- •-Patient with a congestive cardiac insufficiency (NYHA category III or IV), an instable angina pectoris, sustained ventricular tachycardia or ventricular fibrillation episodes or history of myocardial infarction during the last 6 months.
- •-Patient presenting an extension of QT interval (QT corrected according to the Fridericia formula (QTcF)) at the screening or baseline (predose) > 450msec
- •-History of syncope or family history of sudden death or significant cardiac arrhythmia
- •-Risk factors for torsades de pointes: hypokaliaemia, hypomagnesaemia, known structural or ischaemic cardiac disease, bradycardia (HR<55/min) or high grade AV block
- •-Concomitant disease that could prolong QT or increase exposure to the study medication including dehydration, renal or hepatic impairment
- •-Concomitant medication known to increase the QT interval
- •-Patient with an hepatic pathology such as cirrhosis, chronic hepatitis active or persistent, or an elevation of ALAT rate, ASAT rate twice higher than the normal superior limit (NSL)
- •-Patient having leucocytes < 3x109/L, Hb < 90% LIN, platelets < 100x109/L
- •-Patient having a pathology or medical history susceptible to interfere with the realization of the study or results evaluation according to the judgment of the investigator or the study monitor
- •-Patient participating to another clinical trial with another molecule in study during the month before the first dose
- •-Known oversensitivity to somatostatine analogs or another component of prolonged release pasireotide or prolonged release octreotide formulations.
研究者
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