Breast cancer
Conditions
Interventions
Arm A:Pyrotinib combined with taxanes
Arm B:Trastuzumab plus pyrotinib and taxane
Arm C:Trastuzumab plus pertuzumab and taxane
Sponsors
The First Peolple's Hospital of Foshan
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged =18 years old and =70 years old, female; 2) Patients with newly treated unilateral primary invasive breast cancer confirmed by histopathology to be HER2-positive, excluding occult breast cancer, inflammatory breast cancer and eczematoid cancer; 3) The hormone receptor status is clear; 4) Patients with TNM stage II~IIIA (cT2N0M0, cT1N1M0, cT2N1M0, cT3N0M0, cT1N2M0, cT2N2M0, cT3N1M0, cT3N2M0); 5) Have at least one evaluable target lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1; 6) ECOG physical status score 0~1 points; 7) LVEF=55%; 8) Adequate bone marrow functional reserve: white blood cell count =3.0×109/L, neutrophil count =1.5×109/L; platelet count =100×109/L; hemoglobin =90 g/L; 9) AST and ALT = 2 times the upper limit of normal value, alkaline phosphatase = 2 times the upper limit of normal value, total bilirubin = 2 times the upper limit of normal value; serum creatinine = 1.5 times the upper limit of normal value; 10) For female patients who are not menopausal or have not undergone surgical sterilization: agree to use contraception during treatment and for at least 7 months after the last dose of study treatment. 11) Voluntarily join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer, bilateral breast cancer. 2. Patients who are known to be allergic to the active ingredients or other ingredients of the study drug. 3. According to the researcher's judgment, other anti-tumor treatments (except ovarian function inhibitors) are required during neoadjuvant treatment. 4. Those with severe heart disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limited to: ? Fatal arrhythmia or higher grade atrioventricular block (second degree type 2 [Mobitz 2] atrioventricular block or third degree atrioventricular block). ?Unstable angina pectoris. ?Clinically significant valvular heart disease. ?Electrocardiogram shows transmural myocardial infarction. 5. Uncontrollable high blood pressure. 6. Have undergone major surgical operations unrelated to breast cancer within 4 weeks before randomization, or the patient has not fully recovered from such surgical operations. 7. Serious or uncontrolled infections that may affect study treatment or evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positivity, lung infection, etc. 8. Have a history of other malignant tumors in the past 5 years (except for cured cervical carcinoma in situ or skin basal cell carcinoma, etc.). 9. Pregnant or lactating women, and women of childbearing age who refuse to take effective contraceptive measures during the study. 10. People with basic gastrointestinal diseases (especially a history of long-term diarrhea and constipation). 11. Inability to swallow, intestinal obstruction, or other factors that affect drug taking and absorption. 12. The researcher believes that the patient has any other conditions that make him or her unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete remission rate in the breast;Objective remission rate;3 years Invasive disease-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactYe Guolin
The First Peolple's Hospital of Foshan
Outcome results
None listed