跳至主要内容
临床试验/NL-OMON55670
NL-OMON55670已完成3 期

A randomized double-blind, placebo-controlled study of LEE011 in combination with letrozole for the treatment of postmenopausal women with hormone receptor positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease (CLEE011A2301) - CLEE011A2301 - MONALEESA-2

ovartis0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
ovartis
入组人数
24

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • Women >=18 years old, with advanced breast cancer.
  • No prior therapy for advanced disease
  • Postmenopausal. See protocol page 34 for details.
  • Confirmed diagnosis of estrogen-receptor positive and/or progesterone
  • receptor positive, HER2 negative breast cancer.
  • Measurable disease or at least one predominantly lytic bone lesion.
  • ECOG performance status 0 or 1.
  • Adequate bone marrow and organ function (based on central

排除标准

  • Received any CDK4/6 inhibitor.
  • Any prior systemic anti-cancer therapy (including hormonal therapy and
  • chemotherapy) for advanced breast cancer. See protocol page 45 for details.
  • Known history of HIV infection (testing not mandatory).
  • Patient has CNS metastases
  • Active cardiac disease or a history of cardiac dysfunction. See protocol page
  • 46 for details.
  • Prohibited medication. See protocol page 36 for details.

研究者

发起方
ovartis

相似试验