EUCTR2013-003084-61-SE进行中（未招募）1 期
A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease
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
- 650
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. Women with advanced (recurrent or metastatic) breast cancer who received no prior therapy for advanced disease.
- •2. Patient is postmenopausal. Postmenopausal status is defined either by:
- •Prior bilateral oophorectomy
- •Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range
- •Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status (NCCN Guidelines Version 2.2014). Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial.
- •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 HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
- •5. Patient must have either:
- •Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (tumor lesions previously irradiated or subjected to locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented) or,
- •If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of bone lesion after irradiation)
- •6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Other inclusion criteria as defined by protocol 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 357
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 293
排除标准
- •1. Patient who received any CDK4/6 inhibitor.
- •2. Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
- •Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior (neo) adjuvant therapy included letrozole or anastrozole the disease free interval must be greater that 12 months from the completion of treatment until randomization.
- •Patients who received =14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible
- •Any prior (neo) adjuvant anti-cancer therapy mus be stopped at least 5 half lives or 7 days, whichever is longer, before randomization
- •3. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment:
- •That are known strong inducers or inhibitors of CYP3A4/5.
- •That have a known risk to prolong the QT interval or induce Torsades de Pointes.
- •That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
- •Herbal preparations/medications
- •4. 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.
- •5. 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 any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal
- •arrhythmias, or conduction abnormality in the previous 12 months.
- •On screening, 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 or <90 mmHg
- •Other exclusion criteria as defined by protocol may apply.
研究者
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