breast cancer
Conditions
Interventions
test group:dalpiciclib combined with chidamide and letrozole
Sponsors
An Yang Tumor 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 = 75 years must receive LHRH agonist treatment during the study period; 2. Pathological examination confirmed invasive breast cancer of HR+and HER2-; Estrogen receptor (ER) positive (>10%), Progestogen receptor (PR) positive (>1%), HER2 negative. Follow the 2018 ASCO-CAP HER2 negative interpretation guideline standard. Confirmed by the pathological laboratory that the immunohistochemical (IHC) score is 0, or 1+, or 2+, and the in situ hybridization (ISH) test is negative; 3. ECOG score 0-1 points; 4. Stage II-III of the tumor meets the AJCC version 8 standard, and the tumor stage is early (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0) breast cancer patients newly treated; 5. If the main organs function normally, they meet the following standards: (1) The blood routine examination standard should comply with: ANC = 1.5 × 109/L; PLT = 90 × 109/L; Hb = 90g/L; (2) Biochemical examination should meet the following standards: TBIL = Upper limit of normal value (ULN); ALT and AST = 1.5 times the upper limit of normal value (ULN); Alkaline phosphatase = 2.5 times the upper limit of normal value (ULN); BUN and Cr = 1.5 × ULN and creatinine clearance rate = 50 mL/min (CockcroftGault formula); (3) Color echocardiography and echocardiography: left ventricular Ejection fraction (LVEF = 55%); (4) 18 lead ECG QT interval (QTcF) corrected by Fridericia method<470 ms for women; 6. For female patients who have not undergone menopause or surgical sterilization: agree to abstinence or use effective contraceptive methods during the treatment period and at least 7 months after the last administration of medication during the study treatment; Premenopausal or perimenopausal patients (if such patients, combined with OFS, including bilateral ovariectomy or GnRHa drugs), or postmenopausal patients. 7. Volunteer to join this study, sign informed consent, have good compliance, and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Have received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular Targeted therapy, endocrine therapy, etc.) in the past; It does not include cured cervical Carcinoma in situ, Basal-cell carcinoma or squamous cell carcinoma and other malignant tumors; 2. Stage IV (metastatic) breast cancer; 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. breast cancer not confirmed by histopathology; 5. Other malignant tumors have occurred in the past 5 years, except for cured cervical Carcinoma in situ; 6. Severe dysfunction of important organs such as heart, liver, and kidney; 7. Serious heart disease or discomfort, including but not limited to the following diseases: --Confirmed history of heart failure or systolic dysfunction (LVEF100 bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (such as Mobitz II second degree atrioventricular block or third degree atrioventricular block) --Angina requiring anti angina drugs --Clinically significant heart valve disease --ECG shows transmural myocardial infarction --Poor control of hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg) 8. Unable to swallow, chronic diarrhea and Bowel obstruction, there are many factors that affect drug taking and absorption; 9. Participated in other drug clinical trials within 4 weeks prior to enrollment; 10. Those with a known history of allergies to the drug components of this protocol; Have a history of immune deficiency, including positive Diagnosis of HIV/AIDS, HCV, active hepatitis B or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation; 11. Female patients during pregnancy and lactation, female patients with Fertility and positive baseline Pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period and within 7 months after the last study drug use; 12. According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension beyond drug control, severe diabetes, active infection, etc.); 13. Have a clear history of neurological or mental disorders, including epilepsy or dementia. The researcher believes that the patient is not suitable to participate in any other situation of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathologic complete response;Residual cancer burden 0-I; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective control rate;Objective Response Rate;Disease control rate; | — |
Countries
China
Contacts
Public ContactYuan Shi
An Yang Tumor Hospital
Outcome results
None listed