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

ovartis Farmacéutica, S.A.0 个研究点目标入组 97 人开始时间: 2013年10月24日最近更新: 2018年7月23日

适应症

试验速览

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•?Postmenopausal, Estrogen-receptor positive breast cancer
•?Phase Ib Parts 1A and 2A Expansion and Phase II only: No prior systemic treatment in the metastatic setting.
•?Phase Ib Parts 1, 2 and 3 Dose Escalation only: Any number of prior lines of endocrine therapy is allowed with up to one prior cytotoxic regimen in the metastatic or locally advanced setting
•EXPANSIÓN DE DOSIS DE LA FASE IB EN EL BRAZO 1 Y 2 Y FASE II: NINGÚN TRATAMIENTO PREVIO SISTÉMICO EN EL MARCO METASTÁSICO1.
•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 150
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 65

•?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

发起方

ovartis Farmacéutica, S.A.