EUCTR2013-001219-57-IT进行中（未招募）1 期
A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancer
OVARTIS FARMA S.p.A.0 个研究点目标入组 277 人开始时间: 2013年12月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 277
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
- •Postmenopausal, Estrogen-receptor positive breast cancer
- •Phase Ib dose escalation only: Any number of prior lines of endocrine
- •therapy is allowed with the exception of cytotoxic therapy which is
- •limited to one prior line administered in the metastatic or locally
- •advanced setting.
- •Phase Ib dose expansion in Arms 1 and 2 and Phase II: No prior
- •systemic treatment in the 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 192
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 85
排除标准
- •HER2-overexpression in the patient's tumor tissue
- •Patients with active CNS or other brain metastases
- •Major surgery within 2 weeks
- •Acute or chronic pancreatitis
- •Bilateral diffuse lymphangitic carcinomatosis
- •Another malignancy within 3 years
- •Receiving hormone replacement therapy that cannot be discontinued
- •Impaired cardiac function
- •Patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose = 140 mg/dL / 7.8 mmol/L), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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