The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Patient is ≥ 18 years-old
Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
metastatic disease (Stage IV) or inflammatory breast cancer
Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
A history of allergy to the drugs in this study；
Single group
Dalpiciclib
DrugCDK4/6 inhibitor dalpiciclib, 100mg orally qd
Endocrine therapy
DrugFulvestrant/AI
invasive Disease-free Survival (iDFS)
Invasive disease-free survival time is defined as the time from date of enrollment until the first disease recurrence or death from any cause
Disease-free Survival (DFS)
Disease-free survival time is defined as the time from date of enrollment until the first disease recurrence（including carcinoma in situ）or death from any cause.
AEs and SAEs
Adverse events and Adverse events and serious adverse events according to CACTE 5.0
Click on the lead sponsor to view all of their trials.
