Triple-positive breast cancers,TPBCs
Conditions
Interventions
combined treatment :pyrotinib maleate, CDK4/6 inhibitor SHR6390, and letrozole
Sponsors
Shengjing Hospital Affiliated to China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 years or older and less than or equal to 70 years old meet one of the following conditions; (1) Previous bilateral oophorectomy, or aged >= 60 years; (2) Aged 10%), progesterone receptor (PR) positive (> 1%), HER2 receptor positive. Follow the guidelines for positive interpretation of asco-cap HER2 in 2018. Immunohistochemistry (IHC) score was 3 +, or 2 + and positive in situ hybridization (ISH amplification rate >= 2.0) was confirmed by pathology laboratory; 3. Patients with stage II-III initial admission who met the criteria of AJCC 8th Edition; 4. KPS score >= 70; The functional level of organs must meet the following requirements: (1) Bone marrow function The absolute number of neutrophils >= 1.5 * 10^9 / L (growth factor was not used within 14 days); Platelet count >= 100 * 10^9 / L (no corrective treatment was used within 7 days); Hemoglobin >= 100 g / L (no corrective treatment was used within 7 days); (2) Liver and kidney function Total bilirubin = 50 ml / min (Cockcroft Gault formula); (3) Echocardiography: left ventricular ejection fraction >= 50%; (4) 12 lead ECG: QT interval <= 480 Ms. 6. Patients who can accept biopsy; 7. The patients who voluntarily joined the study signed informed consent, had good compliance and were willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Patients who have previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy and endocrine therapy, etc.); 2. Patients receiving other anti-tumor drugs at the same time; 3. Patients with bilateral breast cancer, inflammatory breast cancer or occult breast cancer; 4. Patients with stage IV breast cancer; 5. Patients with breast cancer without histopathological diagnosis; 6. Patients with other malignant tumors in the past 5 years, except the cured cervical carcinoma in situ; 7. Patients with severe heart, liver and kidney dysfunction; 8. There are many factors that affect drug taking and absorption in patients with non swallowing, chronic diarrhea and intestinal obstruction. 9. Patients who participated in other drug clinical trials within 4 weeks before enrollment. 10. Patients with a history of allergy to the components of this regimen; patients with a history of immune deficiency, including HIV positive, hepatitis C virus, active hepatitis B, or other acquired and congenital immunodeficiency diseases, or a history of organ transplantation. 11. Patients who have ever suffered from any heart disease, including: arrhythmia requiring drug treatment or clinical significance; myocardial infarction; heart failure; any other heart disease judged by the researcher as not suitable to participate in this trial. 12. Pregnant and lactating women, fertile women with positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period. 13. According to the judgment of researchers, patients with concomitant diseases that seriously endanger the safety of patients or affect patients' completion of the study (including but not limited to severe hypertension, severe diabetes, active infection, etc.) beyond the control of drugs. 14. Patients with a clear history of neurological or mental disorders, including epilepsy or dementia. 15. Any other situation in which the investigator considered that the patient was not suitable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best overall response rate;Residual cancer burden;Overall survival;Disease-free survival; | — |
Countries
China
Contacts
Public ContactCaigang Liu
Shengjing Hospital Affiliated to China Medical University
Outcome results
None listed