EUCTR2013-002588-24-ES进行中（未招募）不适用
A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer - MONALEESA1
ovartis Farmacéutica , S.A.0 个研究点目标入组 120 人开始时间: 2013年10月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •1. Patient is ? 18 years old at the time of informed consent, with newly
- •diagnosed resectable breast cancer, who received no prior therapy for
- •breast cancer.
- •2. Patient is postmenopausal. Postmenopausal status is defined either
- •? Prior bilateral oophorectomy
- •? Age <60 and amenorrhea for 12 or more months and FSH and
- •estradiol in the postmenopausal range.
- •3. Patient has a histologically (and/or cytologically) confirmed diagnosis
- •of estrogen-receptor positive and/or progesterone receptor positive
- •breast cancer by local laboratory.
- •4. Patient has a grade II or grade III invasive breast cancer
- •5. Patient has HER2 negative breast cancer defined as a negative in situ
- •hybridization test or an IHC status of 0, 1+ or 2+ (if IHC 2+, a negative
- •in situ hybridization (respectively FISH/CISH/SISH) test is required) by
- •local laboratory testing
- •6. Patient has at least one breast lesion with a diameter of ?1.5 cm by
- •ultrasound.
- •7. Patient has an Eastern Cooperative Oncology Group (ECOG)
- •performance status 0 or 1
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Patient has received any prior therapy for breast cancer.
- •2. Patient has a concurrent malignancy or malignancy within 3 years of
- •randomization, with the exception of adequately treated, basal or
- •squamous cell carcinoma, non-melanomatous skin cancer or
- •curatively resected cervical cancer.
- •3. Patient has active cardiac disease or a history of cardiac dysfunction
- •including any of the following:
- •? History of angina pectoris, symptomatic pericarditis, or myocardial
- •infarction within 12 months prior to study entry
- •? History of documented congestive heart failure (New York Heart
- •Association functional classification III-IV)
- •? Documented cardiomyopathy
- •? Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as
- •determined by Multiple Gated acquisition (MUGA) scan or
- •echocardiogram (ECHO)
- •? History of ventricular, supraventricular, nodal arrhythmias, or any
- •other cardiac arrhythmias, Long QT Syndrome or conduction
- •abnormality in the previous 12 months.
- •? Family history of QTc prolongation or of unexplainable sudden
- •death at <50 years of age.
- •? On screening 12 lead ECG, any of the following cardiac
- •parameters: bradycardia (heart rate < 50 at rest), tachycardia
- •(heart rate > 90 at rest), PR interval > 220 msec, QRS interval
- •>109 msec, or QTcF >450 msec.
- •? Systolic blood pressure >160 mmHg or <90 mmHg.
- •4. Patient is currently receiving any of the following medications (see
- •Appendix 1 for details):
- •? That are known strong inducers or inhibitors of CYP3A4.
- •? That have a narrow therapeutic window and are predominantly
- •metabolized through CYP3A4.
- •? That have a known risk to prolong the QT interval or induce
- •Torsades de Pointes.
研究者
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