breast cancer
Conditions
Interventions
Arm A:pyrotinib+trastuzumab+albumin-bound paclitaxel+carboplatin
Sponsors
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age between 18 years and 70 years old, female; 2.Primary, unilateral, invasive breast cancer patients with histopathological diagnosis, excluding occult breast cancer, inflammatory breast cancer, and papillary carcinoma; 3.HER2 expression positive and HR positive (ER and/or PR positive);HER2 expression positive defined as IHC detection showing HER2 as 3+ and/or FISH positive, ER and PR positive defined as IHC detection positive threshold >= 1%; 4.Stage II-IIIA according to the American Joint Committee on Cancer (AJCC) 8th edition breast cancer TNM staging (cT2N0M0, cT1N1M0, cT2N1M0, cT3N0M0, cT1N2M0, cT2N2M0, cT3N1M0, cT3N2M0); 5.At least one evaluable target lesion according to the RECIST 1.1 version; 6.ECOG performance status score of 0~1; 7.LVEF >= 55%; 8.Adequate hematopoietic function reserve: white blood cell count >= 3.0×10^9/L, neutrophil count >= 1.5×10^9/L, platelet count >= 100×10^9/L, hemoglobin >= 90 g/L; 9.AST and ALT <= 2 times the upper limit of normal, alkaline phosphatase <= 2 times the upper limit of normal, total bilirubin <= 2 times the upper limit of normal, serum creatinine <= 1.5 times the upper limit of normal; 10.For non-menopausal or non-surgically sterilized female patients: agree to contraception during the treatment period and at least 7 months after the last dose of study treatment; 11.Voluntarily enroll in this study, sign informed consent, have good compliance and 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 ingredient or other ingredient of the investigational drug; 3.According to the investigators' judgment, other anti-tumor therapy is required during neoadjuvant therapy; 4.Patients with severe heart disease or discomfort who are not expected to tolerate chemotherapy, including but not limited to: A. Fatal arrhythmia or higher grade atrioventricular block (second degree type 2 atrioventricular block or third degree atrioventricular block), B. Unstable angina pectoris, C. Clinically significant heart valvular disease, D. Transmural myocardial infarction revealed by electrocardiogram, E. Uncontrolled high blood pressure. (5) Non-breast cancer related surgery in the 4 weeks prior to enrollment, or not fully recovered from such surgery; 5.Non-breast cancer related surgery in the 4 weeks prior to enrollment, or not fully recovered from such surgery; 6.Serious or uncontrolled infections that may affect the treatment of the study or the evaluation of the study results, including but not limited to active hepatitis virus infection, positive human immunodeficiency virus (HIV) antibodies, lung infections, etc. 7.A history of other malignant tumors within the past 5 years (except cured cervical carcinoma in situ or skin basal cell carcinoma); 8.Patients with underlying gastrointestinal diseases (especially a long history of diarrhea and constipation), inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption; 9.The investigator believes that the patient has any other condition that is not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;event-free survival;overall survival;Breast conservation surgery rate;Safety evaluation; | — |
Countries
China
Contacts
Public ContactPeng Peijian
Fifth Affiliated Hospital, Sun Yat-Sen University
Outcome results
None listed