"An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease" (KANDELA-302)

未提供0 个研究点目标入组 85 人开始时间: 待定

适应症

试验速览

暂无简介。

•Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in
•which the study is taking place at the time of signing the informed consent.
•Participants with histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer.
•Participants must have a stable Eastern Cooperative Oncology Group (ECOG) Performance Status of <=
•Adequate organ function.

•Participants who have received prior systemic treatment in the advanced or metastatic setting.
•Participants who have received prior treatment with any selective cyclin-dependent kinase 4 (CDK4) or cyclin-dependent kinase 2 (CDK2) targeting agent, or any other investigational anticancer drug in any disease setting, except for prior investigational or approved SERDs in the adjuvant setting, provided that disease recurrence occurred more than 12 months after the last dose of endocrine-based therapy.
•Participants with active leptomeningeal disease or uncontrolled, untreated brain metastasis.
•Note: Other protocol-defined inclusion/exclusion criteria may apply."

发起方

未提供