EUCTR2011-003602-25-NL进行中（未招募）不适用
A Phase Ib/randomized phase II study of BEZ235 and trastuzumab versus lapatinib and capecitabine in patients with HER2-positive locally advanced or metastatic breast cancer who failed prior to trastuzumab.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
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
- •Inclusion criteria applicable to Phase Ib and II:
- •Patient is a female = 18 years of age.
- •Patient has a histologically and/or cytologically confirmed diagnosis of HER2-positive invasive breast cancer with inoperable locally advanced or metastatic disease
- •Patients with controlled or asymptomatic CNS metastases are eligible
- •Patient has adequate bone marrow and organ functions, and has recovery from all clinically significant toxicities related to prior anti-neoplastic therapies
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelets = 100 x 109/L
- •Hemoglobin (Hgb) = 9.0 g/dL
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x ULN (or = 5.0 x ULN if liver metastases are present)
- •Total serum bilirubin = 1.5 x ULN (in patients with known Gilbert Syndrome, a total bilirubin = 3.0 x ULN, with direct bilirubin = 1.5 x ULN)
- •Serum creatinine = 1.5 x ULN
- •Fasting plasma glucose (FPG) = 140mg/dL [7.8 mmol/L]
- •HbA1c = 8%
- •Patient has received prior trastuzumab (alone or in combination) but NO more than 3 prior cytotoxic chemotherapy lines
- •Prior endocrine and radiotherapy allowed
- •Patient has ECOG performance status of 0-2 (Phase Ib) or 0-1 (Phase II)
- •Additional criteria for Phase II:
- •Available tumor tissue (/archival or fresh) for biomarker analysis; known PI3K activation status
- •At least one measurable lesion as per RECIST 1.1
- •Patient has received prior treatment with a taxane
- •Patient has trastuzumab-resistance disease” defined as:
- •Recurrence while on trastuzumab (or T-DM1) or within 12 months since the last infusion in the adjuvant setting
- •Progression while on or within 4 weeks since the last infusion of trastuzumab (or T-DM1) in the locally advanced or metastatic setting
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •Exclusion criteria applicable for Phase Ib and II:
- •Previous treatment with PI3K and/or mTOR inhibitors
- •Symptomatic/uncontrolled Central Nervous System (CNS) metastases
- •Concurrent malignancy or malignancy in the last 3 years prior treatment
- •Wide field radiotherapy = 28 days or limited field radiation for palliation = 14 days prior to starting study drug
- •Active cardiac disease (e.g. LVEF less than institutional lower limit of normal, QTcF > 480 msec, 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
- •Intolerance or contraindications to trastuzumab treatment
- •Pregnant or nursing (lactating) woman
- •Additional exclusion criterion for Phase II:
- •Prior treatment with capecitabine and lapatinib
- •Intolerance or contraindications to capecitabine and lapatinib
- •Previous treatment with HER-2 targeted agents other than trastuzumab or T-DM1
- •Peripheral neuropathy = Grade 2
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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