This study aimed to evaluate the efficacy and safety of Dalpiciclib combined with Letrozole in the maintenance treatment of HR positive and HER2 negative metastatic breast cancer after first-line chemotherapy.
Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
Age: 18 - 75 years old
Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1
Functions of liver and kidney is normal
Confirmed diagnosis of HER2 positive disease.
Central nervous system metastasis
Patients who received prior treatment with any CDK4/6 inhibitor.
Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention；
Shuangyue Liu
Lead sponsor
West China Hospital
Sponsor institution