Trastuzumab Combined With Pyrrolidine and Chemotherapy for Locally HER2 Positive Breast Cancer
Trial Parameters
Brief Summary
This study is a one-arm, open, phase II clinical study, and the study subjects are locally advanced and inflammatoryPatients with sexual or early HER2-positive breast cancer entered the trial period after signing informed consentTo evaluate trastuzumab combined with pyrrolitinib and chemotherapy regimen (TCbH+Py) for HER2 positive breastPathologic complete response rate (pCR) for adenocarcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Female between 18 and 70 years old; 2. Histologically confirmed as invasive breast cancer; 3. ECOG PS 0-1; 4. The expected survival time is not less than 12 weeks; 5. Standard immunohistochemical HER2-positive breast cancer patients (IHC +++ or FISH amplification); 6. The status of hormone receptors (ER and PR) can be known. 7. Clinical examination or imaging examination of primary lesion \>2cm; 8. Patients who are operable (T2-3, N0-1, M0), locally advanced (T2-3,N2-3, M0 or T4A-C, any N, M0) or inflammatory breast cancer (T4d, any N, M0) and who have not received any previous anti-tumor therapy (including radiotherapy, chemotherapy, targeted therapy, except those who have received bisphosphonate therapy previously); 9. Echocardiography indicated left ventricular ejection fraction (LVEF)≥55%; 10. Adequate organ and bone marrow function, as defined below: a. Neutrophil count (ANC)≥ 1,500/mm3 (1.5 × 109/L); B. Platelet count (PLT)≥ 100,000/mm3(100 × 109/L); C. Hem