Breast cancer
Conditions
Interventions
Experimental group:Dalpiciclib combined with standard endocrine in adjuvant therapy
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Postmenopausal or premenopausal/perimenopausal women aged >=18 years and 10%), progesterone receptor (PR) positive (>1%); 3. ECOG score 0~1 points; 4. The main organs function normally: (1) Blood routine: 1) Neutrophil (ANC)>=1.5*10^9/L; 2) Platelet count (PLT)>=90*10^9/L; 3) Hemoglobin (Hb)>=90 g/L; (2) Blood biochemistry: 1) Total bilirubin (TBIL) = 55%; (4) 12-lead ECG: Fridericia-corrected QT interval (QTcF) =4; (2) When the number of lymph node metastases is 1-3, one of the following high-risk factors must be met: 1) Postoperative pathological detection of primary tumor diameter >=5cm; 2) Histological grade of primary tumor grade III and above; 3) Vascular infiltration was seen in postoperative pathology; 4) Breast lesions or ipsilateral axillary lymph nodes have residual invasive cancer after neoadjuvant therapy; 5) Ki67>=30%; 8. No evidence of recurrence or metastatic disease after surgery; 9. Voluntarily join the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Local/regional recurrence/metastasis confirmed at the time of enrollment; 2. Those who have received the CDK4/6 inhibitor Dalsilir or other CDK4/6 inhibitors in the past; 3. Those with severe insufficiency of vital organs such as heart, liver and kidney; 4. Severe heart disease or discomfort, including but not limited to the following: (1) History of diagnosis of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmia (eg, ventricular tachycardia), or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV block); (3) Angina pectoris requiring antianginal drug treatment; (4) Clinically significant heart valve disease; (5) ECG showing transmural myocardial infarction; (6) Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg); 5. Those who suffer from mental illness or abuse of psychotropic substances and cannot cooperate; 6. Inability to swallow, chronic diarrhea, and intestinal obstruction, there are many factors that affect drug taking and absorption; 7. Participated in clinical trials of other drugs within 4 weeks before enrollment; 8. Pregnant or lactating female patients; 9. Those who are deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Invasive disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival;Distant disease/recurrence free survival, DDFS;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactWei You
Henan Provincial People's Hospital
Outcome results
None listed