breast cancer
Conditions
Interventions
Test group:Dalpiciclib and letrozole combined with pyrotinib maleate and trastuzumab
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria in order to be enrolled in this trial: 1.Female patients aged 18 years or older and 75 years or younger who meet one of the following criteria: (1) Previous bilateral oophorectomy or age = 60 years old; (2) Age10%), progesterone receptor (PR) positive (>1%), and HER2 receptor positive. Follow the 2018 ASCO-CAP HER2 positive interpretation guidelines. Confirmed by the pathology laboratory with an immunohistochemistry (IHC) score of 2+and positive in situ hybridization (ISH) detection (ISH amplification rate = 2.0); 3. Patients with stage II-III initial treatment who meet the AJCC 8th edition criteria for tumor staging; 4. ECOG score 0-1 points; 5. The functional level of organs must meet the following requirements: (1) Bone marrow function ANC = 1.5 × 109/L (no growth factor used within 14 days); PLT = 100 × 109/L (no corrective treatment used within 7 days); Hb = 100 g/L (no corrective treatment used within 7 days); (2) Liver and kidney function ? TBIL=ULN; ALT and AST = 3 × ULN (ALT and AST = 5 × ULN in patients with liver metastases); BUN and Cr = 1.5 × ULN and creatinine clearance rate = 50 mL/min (Cockcroft Gault formula); (3) Cardiac ultrasound: LVEF = 55%; (4) 12 lead electrocardiogram: QT interval = 480 ms; 6. Able to accept puncture biopsy; 7. Voluntarily join this study, sign informed consent, have good compliance, and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: Anyone who falls under any of the following circumstances cannot participate in this clinical study: 1. Have received any form of anti-tumor treatment in the past (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 2. Simultaneously receive any other anti-tumor treatment; 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. Stage IV breast cancer; 5. breast cancer not confirmed by histopathology; 6. Other malignant tumors have appeared within the past 5 years, except for cured cervical carcinoma in situ; 7. Patients with severe dysfunction of important organs such as liver, liver, and kidneys; 8. Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting medication intake and absorption; 9. Participated in clinical trials of other drugs within 4 weeks prior to enrollment; 10. Those who are known to have a history of allergies to the components of this drug regimen; History of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation; 11. Have suffered from any heart disease, including: (1) arrhythmias that require medication or have clinical significance; (2) Myocardial infarction; (3) Heart failure; (4) Any other heart disease or condition that the researcher deems unsuitable for participation in this trial; 12. Pregnant and 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 throughout the entire trial period; 13. 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.); 14. Have a clear history of neurological or mental disorders, including epilepsy or dementia. The researchers believe that the patient is not suitable to participate in any other circumstances of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ki-67; | — |
Secondary
| Measure | Time frame |
|---|---|
| Residual cancer burden;objective response rate;Pathologic complete response;Milk retention rate;Event free survival ;Disease-free survival ;Non invasive disease survival;Survival without distant diseases;Overall survival;Patient reported health outcomes;Drug related safety indicators; | — |
Countries
China
Contacts
Public ContactYuanting Gu
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed