EUCTR2012-005461-13-GB进行中（未招募）1 期
A phase Ib/II trial of LEE011 in combination with everolimus (RAD001) and exemestane in the treatment of postmenopausal women with estrogen receptor positive Her2 negative locally advanced or metastatic breast cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 185
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
- •- Adult women (= 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy
- •- Histological or cytological confirmation of estrogen-receptor positive (ER+) breast cancer
- •- A representative tumor specimen must be available for molecular testing. An archival tumor sample may be submitted; if one is not available, a newly obtained tumor specimen must be submitted instead
- •- Postmenopausal women. Postmenopausal status is defined either by: - Age = 18 with prior bilateral oophorectomy - Age = 60 years - Age <60 years with amenorrhea for at least 12 months and both follicle-stimulating hormone (FSH) and estradiol levels are in postmenopausal range (according to the local laboratory)
- •- Recurrence while on, or within 12 months of end of adjuvant treatment with letrozole or anastrozole, or
- •- Progression while on, or within one month of end of letrozole or anastrozole treatment for locally advanced or metastatic breast cancer.
- •-Patients must have:
- •Measurable disease*: At least one lesion that can be accurately measured in at least one dimension = 20 mm with conventional imaging techniques or = 10 mm with spiral CT or MRI or
- •Bone lesions: lytic or mixed (lytic + sclerotic) in the absence of measurable disease as defined above.
- •- ECOG Performance Status 0-1. *Exception for Phase Ib patients: measurable disease is not required
- •other, protocol defined criteria may apply
- •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 111
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 74
排除标准
- •1.Patients with Her2-overexpressing tumors by local laboratory testing
- •(IHC 3+ staining or in situ hybridization positive).
- •2. Patients who received more than one chemotherapy line for advanced breast cancer*.
- •3. Previous treatment with CDK4/6 inhibitors, exemestane or mTOR
- •inhibitors*.
- •4. History of active or symptomatic brain or other CNS metastases.
- •5. Impaired cardiac function or clinically significant cardiac diseases,
- •including any of the following:
- •Left ventricular ejection fraction (LVEF) < 45% or less than the
- •institution lower limit of normal as determined by multiple gated acquisition scan (MUGA) or echocardiogram (ECHO)
- •Congenital long QT syndrome or family history of unexpected sudden
- •cardiac death
- •QT corrected with Fredericia's (QTcF) >470 ms for females on
- •screening ECG
- •Any other clinically significant heart disease such as angina pectoris,
- •resting bradycardia, left bundle branch block, ventricular
- •tachyarrhythmia, unstable atrial fibrillation, Right bundle branch block with left anterior hemiblock (bifascicular block), acute myocardial infarction or any heart disease that requires the use of a cardiac pacemaker or implantable cardioverter defibrillator = 3 months prior to starting study drug.
- •6. Patients who are currently receiving treatment with agents that are
- •known to cause QTc prolongation in humans.
- •7. Patients who are currently receiving treatment (within five days prior
- •to randomization) with strong and moderate inhibitors or inducers of
- •CYP3A4/5, substrates of CYP3A4/5 with a narrow therapeutic index, strong and moderate inhibitors of P-glycoprotein (P-gp), strong and moderate Pgp/ CYP3A4 dual inhibitors and strong inducers of P-gp.
- •*Exceptions for Phase Ib patients:
- •1. Patients who received more than two prior lines of chemotherapy are
- •2. Patients who received CDK4/6 inhibitors, exemestane or mTOR
- •inhibitors are not excluded from phase Ib.
研究者
相似试验
进行中（未招募）
1 期
Phase Ib/II trial of LEE011 with everolimus (RAD001) and exemestane in the treatment of ER+ Her2- advanced breast cancerestrogen receptor positive, Her2- locally advanced or metastatic breast cancerMedDRA version: 16.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2012-005461-13-ITOVARTIS FARMA S.p.A185
进行中（未招募）
1 期
Phase Ib/II trial of LEE011 with everolimus (RAD001) and exemestane in the treatment of ER+ Her2- advanced breast cancerestrogen receptor positive, Her2- locally advanced or metastatic breast cancerEUCTR2012-005461-13-ESovartis Farmacéutica, S.A.185
进行中（未招募）
不适用
Phase Ib/II trial of LEE011 with everolimus (RAD001) and exemestane in the treatment of ER+ Her2- advanced breast cancerestrogen receptor positive, Her2- locally advanced or metastatic breast cancerEUCTR2012-005461-13-FRovartis Pharma Services AG185
进行中（未招募）
1 期
Phase Ib/II trial of LEE011 with everolimus (RAD001) and exemestane in the treatment of ER+ Her2- advanced breast cancerEUCTR2012-005461-13-DEovartis Pharma Services AG185
进行中（未招募）
1 期
Study of LEE011 with fulvestrant and BYL719 or BKM120 in advanced breast cancerBreast CancerHormone receptor positive, HER2 negativeMedDRA version: 16.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2013-004587-65-ITovartis Farma220