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；
Single group
Dalpiciclib combined with Letrozole
DrugA multicenter, single arm, prospective Phase II clinical study
Progression Free Survival (PFS)
The time from the enrollment of the subject until the first recording of tumor progression (evaluated according to RECIST 1.1 criteria) or death from any cause.
Progression Free Survival 2(PFS2)
The time from the first chemotherapy for the metastatic stage by the subject to the first recording of tumor progression (evaluated according to RECIST 1.1 standards) or death from any cause.
Overall Survival(OS)
OS was defined as the time from the first study treatment to the date of death from any cause
Objective Response Rate（ORR）
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
Clinical Benefit Rate (CBR)
The percentage of participants who received study treatment and evaluated the best overall efficacy according to RECIST 1.1 criteria as complete remission (CR), partial remission (PR), and disease stability (SD) ≥ 24 weeks.
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the percentage of patients with a complete response (CR), partial response (PR) and stable disease (SD).
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Shuangyue Liu
Lead sponsor
West China Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
