Breast cancer
Conditions
Interventions
Group A:standard chemotherapy regimen
Group B:Dalpicilib combined with AI
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this trial: 1. Female patients aged =18 years and =75 years; 2. Postmenopausal or perimenopausal female patients, and at least one of the following must be met:Bilateral oophorectomy was performed in the past, or age = 60 years;Age 50%, PR > 20%, and ki67 = 20% 4. ECOG score 0 - 1; 5. The functional level of organs must meet the following requirements: 1. Blood routine • Neutrophil count (ANC) = 1.5 × 109/L (no hematopoietic stimulating factor drugs were used within 14 days before the first administration of the study); • Platelet count (PLT) = 90 × 109/L (no blood transfusion within 14 days before the first administration of the study); • Hemoglobin (Hb) = 90 g/L; 2. Blood biochemistry • TBIL = 1.5 × ULN; • ALT and AST = 1.5 × ULN; • ALP = 2.5 ULN • BUN and Cr = 1.5 × ULN; 3. Cardiac function • Echocardiogram: LVEF = 50%; • 12-lead electrocardiogram: QT interval corrected by Fridericia method < 470 msec. 6. Voluntarily join this study, sign the informed consent, have good compliance and be willing to cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: Any of the following situations disqualifies a subject from being selected: 1. Past history of local or regional recurrent disease in the breast; 2. Tumor with a clinical stage of IV (metastatic) breast cancer; 3. History of any malignancy other than breast cancer within the past 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or squamous cell carcinoma; 4. Simultaneous receipt of anti-tumor therapy in other clinical trials; 5. Underwent major breast cancer-unrelated surgical procedures within 4 weeks prior to randomization, or the patient has not fully recovered from such surgical procedures; 6. Severe heart diseases or disorders, including but not limited to the following diseases: 1. Confirmed history of heart failure or systolic dysfunction (LVEF 100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia) or higher-grade atrioventricular block (i.e., Mobitz type II second-degree atrioventricular block or third-degree atrioventricular block); 3. Angina pectoris requiring anti-anginal drug treatment; 4. Clinically significant heart valve disease; 5. Transmural myocardial infarction shown on ECG; 6. Poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg) 7. Inability to swallow, intestinal obstruction or other factors that affect drug administration and absorption; 8. Past history of diagnosed neurological or mental disorders, including patients without autonomous behavior ability or with mental illness; 9. Past history of gastrointestinal diseases with diarrhea as the main symptom; 10. Known history of allergy to the drug components of this protocol; history of immune deficiency, including positive HIV test, or other acquired or congenital immune deficiency diseases, or history of organ transplantation; 11. Suffering from severe concomitant diseases or other comorbidities that interfere with the planned treatment, including infectious diseases with active infections, or any other situation where the researcher deems the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual cancer burden (RCB) 0-I; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR);tpCR;Preoperative endocrine prognostic index, PEPI;Safety; | — |
Countries
China
Contacts
Public ContactQiao Cheng
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed