EUCTR2011-002400-32-FR进行中（未招募）不适用
A dose-finding phase Ib study followed by an open-label, randomized phase II study of BEZ235 plus paclitaxel in patients with HER2 negative, inoperable locally advanced or metastatic breast cancer
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
- 230
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 breast cancer.
- •Patient has radiological evidence of inoperable locally advanced or metastatic breast cancer.
- •Patient has HER2 negative disease.
- •Patient has adequate bone marrow and organ function.
- •Additional criteria for Phase II:
- •Patient has a known PI3K status (activated or wildtype) based on results from a Novartis designated laboratory prior to start of treatment.
- •Patient has recent radiological documentation of recurrent disease or newly diagnosed disease.
- •Patient has at least one measurable lesion as per RECIST 1.1.
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 170
排除标准
- •Exclusion criteria applicable for Phase Ib and II:
- •Patient has received previous treatment with PI3K and/or mTOR pathway inhibitors.
- •Patient has active uncontrolled or symptomatic central nervous system (CNS) metastases.
- •Patient has received wide field radiotherapy or irradiation of = 25% of the bone marrow = 28 days or limited field radiation for palliation = 14 days prior to starting study drug or has not recovered from side effects of such therapy.
- •Patient has active cardiac disease or a history of cardiac dysfunction.
- •Patient has a family history of congenital long or short QT, or known history of QT/QTc prolongation or Torsades de Pointes (TdP).
- •Patient has inadequately controlled hypertension (i.e., SBP>180 mmHg or DBP>100mmHg).
- •Patient has uncontrolled diabetes mellitus.
- •Patient has impairment of GI function or GI disease that may significantly alter the absorption of BEZ235 and/ or paclitaxel.
- •Additional exclusion criterion for Phase II:
- •Patient has received any prior chemotherapies for the inoperable locally advanced or metastatic disease.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究者
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