NCT01288092撤回2 期
A Phase II Study of Orally Administered BEZ235 Monotherapy in Patients With Hormone Receptor Positive, HER2 Negative, Metastatic Breast Cancer, With or Without PI3K Activated Pathway
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Progression-free survival rate after 16 weeks of treatment
研究概览
简要总结
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. Patients will be stratified into 3 groups according to their PI3K (phosphatidylinositol 3-Kinase) pathway activation status.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female ≥ 18 years
- •ECOG performance status ≤ 2
- •Histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and HER2 negative)
- •Known PI3K activation status (defined by PIK3CA (Phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and PTEN PTEN (Phosphatase and Tensin Homolog) mutation/expression)
- •Prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
- •Objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per RECIST
- •Adequate bone marrow and organ function
排除标准
- •Previous treatment with PI3K and/or mTOR inhibitors
- •Symptomatic Central Nervous System (CNS) metastases
- •Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
- •Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
- •Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) < 50%, QTcF > 480 msec on screening ECGelectrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
- •Inadequately controlled hypertension
- •Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235
- •Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists
- •History of photosensitivity reactions to other drugs
- •Pregnant or nursing (lactating) woman
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
BEZ235
Experimental
干预措施: BEZ235 (Drug)
结局指标
主要结局
Progression-free survival rate after 16 weeks of treatment
时间窗: 16 weeks after the first BEZ235 administration
次要结局
- determine the efficacy of BEZ235 (objective response rate)(about 6 months)
- evaluate the clinical benefit rate of BEZ235(about 6 months)
- evaluate the time to response(about 6 months)
- evaluate the Progression Free Survival Rate at 16-week & 24-week using the Kaplan-Meier method(16-week & 24-week after the first BEZ235 administration)
- evaluate safety of BEZ235 (frequency and severity of Adverse Events, abnormal laboratory values, other safety data as appropriate)(30-35 days after treatment discontinuation)
研究者
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