Triple-positive breast cancers, TPBCs
Conditions
Interventions
combined treatment group:Pyrotinib Maleate, Trastuzumab, SHR6390 and Letrozole in combination for neoadjuvant treatment
Sponsors
Shengjing Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged >= 18 and = 60 years old; (2) Age 10%), progesterone receptor (PR) positive (> 1%), and HER2 receptor positive. Follow the 2018 edition of the ASCO-CAPHER2 positive interpretation guidelines. Confirmed by the pathology laboratory that the immunohistochemistry (IHC) score is 3+, or 2+ and the in situ hybridization (ISH) test is positive (ISH amplification rate >= 2.0); 3. Stage II-III stage-na?ve patients whose tumor staging meets AJCC 8th edition criteria; 4. KPS score >= 70 points; 5. The functional level of organs must meet the following requirements: (1) Bone marrow function: 1) Neutrophils (ANC) >= 1.5 x 10^9 /L (no growth factor used within 14 days); 2) Platelets (PLT) >= 100 x 10^9 /L (no corrective treatment within 7 days); 3) Hemoglobin (Hb) >= 100 g/L (no corrective treatment within 7 days); (2) Liver and kidney function: 1) Total bilirubin (TBIL) = 50 mL/min (Cockcroft-Gault formula); (3) Echocardiography LVEF >= 50%; (4) 12-lead ECG QT interval <= 480 ms; 6. Able to accept biopsy; 7. Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.); 2. Receive any other anti-tumor therapy at the same time; 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. Stage IV breast cancer; 5. Breast cancer that has not been diagnosed by histopathology; 6. There have been other malignant tumors in the past 5 years, except for cured carcinoma in situ of the cervix; 7. Severe heart, liver, kidney and other vital organ dysfunction; 8. Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors that affect drug taking and absorption; 9. Participated in other drug clinical trials 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 testing, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or organ transplantation history; 11. Previously suffered from any heart disease, including: (1) Cardiac arrhythmias that require drug treatment or have clinical significance; (2) myocardial infarction; (3) Heart failure; (4) Any other heart disease judged by the researcher to be unsuitable for participating in this trial; 12. Female patients who are pregnant or breastfeeding, female patients who are fertile and have a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period; 13. According to the investigator's judgment, there is a serious hazard to the patient's safety, or concomitant diseases that affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.); 14. There is a clear history of neurological or mental disorders in the past, including epilepsy or dementia. Any other conditions that the investigator believes that the patient is not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response (tpCR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Best overall response rate (BORR);Breast pathologic complete response (bpCR);Residual cancer burden (RCB);Molecular targets;Overall survival;Disease-free survival of 5 years;Adverse events;Severe adverse events; | — |
Countries
China
Contacts
Public ContactCaigang Liu
Shengjing Hospital of China Medical University
Outcome results
None listed