Breast cancer
Conditions
Interventions
Experimental group:SHR6390 combined with letrozole
Sponsors
The First Affiliated Hospital of Zhengzhou University
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%), HER2 negative. Follow the 2018 version of the ASCO-CAP HER2 Negative Interpretation Guidelines. Immunohistochemistry (IHC) score of 0, or 1+, or 2+ confirmed by a pathology laboratory and negative in situ hybridization (ISH); 3. ECOG score 0~1 points; 4. The tumor staging meets the AJCC 8th edition standard II-III stage, and the tumor stage is early stage (T2-3, N0-1, MO) or locally advanced (T2-3, N2 or N3, MO) newly treated breast cancer patients ; 5. The main organs are functioning normally, that is, the following criteria are met: (1) The blood routine examination standards must meet: ANC >=1.5*10^9/L; PLT >=90*10^9/L; Hb >=90g/L; (2) Biochemical tests should meet the following criteria: TBIL=50 mL/min (CockcroftGault formula); (3) Cardiac ultrasound and echocardiography: left ventricular ejection fraction (LVEF>=55%); (4) 18-lead ECG with Fridericia-corrected QT interval (QTcF) in women <470 ms; 6. For non-menopausal or surgically sterilized female patients: during treatment and for at least 7 months after the last dose of study treatment, consent to abstinence or use of effective contraception; premenopausal or perimenopausal patients (if Such patients need to be combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or postmenopausal patients; 7. Voluntarily join the study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Received any form of anti-tumor therapy in the past (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); excluding 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 without histopathological diagnosis; 5. Other malignant tumors have occurred in the past 5 years, except for the cured cervical carcinoma in situ; 6. Those with severe insufficiency of vital organs such as heart, liver and kidney; 7. Severe heart disease or discomfort, including but not limited to the following diseases: (1) Diagnosed history 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); 8. Inability to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug taking and absorption; 9. Participated in clinical trials of other drugs within 4 weeks before enrollment; 10. Those who are known to have a history of allergies to the drug components of this regimen; have a history of immunodeficiency, including positive HIV test, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or organ transplantation history; 11. Pregnant or lactating female patients, female patients with fertility and positive baseline pregnancy test results, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study drug; 12. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.); 13. History of clear neurological or psychiatric disorders, including epilepsy or dementia. Any other conditions for which the patient was deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete cell cycle arrest;Residual cancer burden;Quality of life score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);bpCR;tpCR;PEPI; | — |
Countries
China
Contacts
Public ContactYuanting Gu
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed