Breast Cancer
Conditions
Interventions
Intervention group:epirubicin, cyclophosphamide, pyrotinib and trastuzumab
Sponsors
First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Female aged 18 to 70 years; 2. ECOG score as 0 or 1; 3. Stage II to III newly diagnosed breast cancer. Diagnosed by pathological examination with hollow needle biopsy before therapy started and resectable. immunohistochemistry (IHC) method examination showed: HER2 (3+), or HER2 (2+) with additional positive result for fluorescence in situ hybridization (FISH) examination; 4. According to the RECIST 1.1 criteria, at least one focus of the cancer is measurable; 5. With no distant metastasis according to abdominal ultrasound and breast X-ray and whole body bone scan and fine needle aspiration to local lymph node enlargement. With no other malignancy; 6. The following requirements are met: (1) absolute neutrophil count (ANC) >= 1.5 x 10^9/L; blood platelet(PLT) >= 90 x 10^9/L; hemoglobin (Hb) >= 90 g/L; (2) total bilirubin (Tbil) = 55% by cardiac color Doppler ultrasound; (4) QT interval corrected by Fridericias formulae (QTcF)< 470 msec; 7. Capable to follow the scheme; 8. Willing to join in the study and agree to use the trastuzumab as the standard scheme for HER2-positive breast cancer and sign the informed consent; 9. Regional lymph node status is clear; 10. The hormone receptor status is clear; 11. The expected survival is no less than 12 weeks; 12. Never received any treatment, including chemotherapy, radiotherapy, targeted therapy and biotherapy.
Exclusion criteria
Exclusion criteria: 1. Being pregnant or breasting-feeding or unwilling to use any effective contraceptive method while being of reproductive age; 2. With serve complication of heart, liver, kidney or endocrine system and with expected survival period less than 2 year; 3. Unable to swallow the durgs; ileus; with any other condition that may affect the intake or absorption of the durgs; allergic to the drugs involved in the study; 4. Karnofsky score less than 60; 5. Metastatic or bilateral breast cancer; 6. Inflammatory breast cancer; 7. Left ventricular ejection fraction (LVEF) was less than 55% by echocardiography; 8. Not suitable for the trial because of other reasons according to the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate);pCR (pathologic Complete Response);DFS (Disease-Free Survival);OS (Overall Survival); | — |
Countries
China
Contacts
Public ContactJun Jiang,Yi Zhang
First Affiliated Hospital of Army Medical University
Outcome results
None listed