Breast cancer
Conditions
Interventions
single arm:Pyrotinib tablets: 400mg, QD, P.O., Q3W, a total of 6 cycles.
Trastuzumab: Trastuzumab: load dose of 8mg/kg for the first cycle and 6mg/kg for the subsequent cycle , IVGTT, D1, Q3W, a total of 6 cycles. Vinorelbine: 25mg/m2, d1, d8, Q3W, a total of 6 cycles.
Sponsors
Breast Oncology Center, Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-75 with breast cancer; 2. ECOG score 0-1; 3. Patients with histologically confirmed invasive breast cancer, neoadjuvant therapy with trastuzumab and pertuzumab combined with chemotherapy evaluated SD or PD early (Recist1.1 criteria); 4. Pathologically confirmed her2-positive breast cancer, HER2 positive by immunohistochemistry (IHC) staining and/or fluorescence in situ hybridization (FISH) (confirmed by the investigator in the study center); 5. Known hormone receptor status (ER and PgR); 6. Normal function of main organs: (1) Blood routine: Neutrophil (ANC) >= 1.5×10^9/L; Platelet count (PLT) >= 90×10^9/L; Hemoglobin (Hb) >= 90g/L; (2) Blood biochemistry: Total bilirubin (TBIL) = 55%; (4) 12-lead ELECTROcardiogram: The QT interval (QTcF) corrected by Fridericia method was < 470 msec. 7. For women who are pre-menopausal or have not undergone surgical sterilization, agree to abstinence or use an effective non-hormonal contraceptive method during treatment and for 8 weeks after the last dose during study treatment; 8. The researcher thinks it will benefit; 9. Voluntarily participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Those who had previously received anti-HER2 therapy with pyrrotinib, lenatinib, lapatinib and other tyrosine kinase inhibitors; 3. Concurrent antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonates, and immunotherapy; 4. Had undergone major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or had not fully recovered from such surgery; 5. Serious heart disease or discomfort, including but not limited to: (1) history of diagnosis of heart failure or systolic dysfunction (LVEF 100bpm, significant ventricular arrhythmia (such as ventricular tachycardia) or higher atrioventricular block (i.e. Mobitz II second or third degree ATrioventricular block); (3) angina pectoris requiring anti-angina drug treatment; (4) valvular heart disease with clinical significance; (5) ECG shows transmural myocardial infarction (6) Poor control of hypertension (systolic blood pressure > 180mmHg and/or diastolic blood pressure > 100mmHg) 6. Inability to swallow, intestinal obstruction or other factors affecting drug intake and absorption; 7. Known history of allergy to the drug components of this regimen; A history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, or a history of organ transplantation; 8. Suffering from mental illness or psychotropic substance abuse; 9. Pregnant or lactating women; 10. Have a serious concomitant disease or other concomitant disease that interferes with planned treatment, or any other condition that the investigator considers inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Countries
China
Contacts
Public ContactZhou Xin
Chongqing University Cancer Hospital
Outcome results
None listed