A phase Ib/II, multicenter, study of the combination of LEE011 and BYL719 with letrozole in adult patients with advanced ER+ breast cancer

ovartis Pharma Services AG0 个研究点目标入组 253 人开始时间: 2013年12月31日最近更新: 2020年11月23日

试验速览

暂无简介。

•Postmenopausal, Hormone-receptor positive breast cancer
•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 advanced (metastatic or locally advanced) setting.
•Dose expansion:
•Arms 1,2 and 3: No prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole or anastrozole for a maximum duration of one month prior to starting study treatment; Patients who received (neo) adjuvant therapy
•for breast cancer are eligible.
•Other protocol-defined inclusion/exclusion criteria may apply - see protocol for additional details
•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 152
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 101

•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
•Diffuse lymphangitic carcinomatosis
•Another malignancy within 3 years
•Receiving hormone replacement therapy that cannot be discontinued
•Impaired cardiac function
•Other protocol-defined inclusion/exclusion criteria may apply - see protocol for details

发起方