Breast Cancer
Conditions
Interventions
Intervention group:Pyrotinib, Trastuzumab, Pertuzumab, Docetaxel, Carboplatin
Sponsors
the First Affiliated Hospital of Army Medical University, PLA
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients aged 18-75; 2. ECOG score 0-1 points; 3. Histologically confirmed invasive breast cancer, patients who did not reach PR in early assessment after neoadjuvant therapy with trastuzumab and pertuzumab combined with chemotherapy; 4. HER2 expression-positive breast cancer confirmed by pathological testing, and immunohistochemical (IHC) staining showed that HER2 was 3+ and/or fluorescence in situ hybridization (FISH) positive (confirmed by the investigator of the test center); 5. Known hormone receptor status (ER and PgR); 6. Normal function of major organs: blood routine: neutrophil (ANC) >=1.5x10^9/L; platelet count (PLT) >=90x10^9/L; hemoglobin (Hb) >=90 g/L ;Blood biochemistry: total bilirubin (TBIL)=55%; 12-lead ECG: Fridericia-corrected QT interval ( QTcF) < 470 msec; 7. For non-menopausal or surgically sterilized female patients: during the treatment period and within 8 weeks after the last dose in the study treatment, agree to abstain from sex or use an effective non-hormonal drug contraceptive method; 8. The researcher believes that it can 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 have previously received anti-HER2 therapy with pyrotinib, neratinib, lapatinib and other tyrosine kinase inhibitors; 3. At the same time receiving anti-tumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy and immunotherapy; 4. Received major surgical operations unrelated to breast cancer within 4 weeks before screening, or the patient has not fully recovered from such surgical operations; 5. Severe heart disease or discomfort, including but not limited to the following diseases: History of heart failure or systolic dysfunction (LVEF 100bpm , significant ventricular arrhythmias (eg, ventricular tachycardia) or higher-grade AV block (ie, Mobitz II second-degree AV block or third-degree AV block); patients requiring antianginal medication Angina pectoris; clinically significant heart valve disease; ECG showing transmural myocardial infarction; poorly controlled hypertension (systolic >180 mmHg and/or diastolic >100 mmHg); 6. Inability to swallow, intestinal obstruction or other factors that affect drug taking and absorption; 7. Those who are known to have a history of allergies to the drug components of this regimen; have a history of immunodeficiency, including a positive HIV test, or have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 8. Those who suffer from mental illness or abuse of psychotropic substances and cannot cooperate; 9. Pregnant or lactating female patients; 10. Those who are deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pathological complete response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR (Objective Response Rate);DCR(Disease Control Rate);iDFS(Invasive Disease-Free Survival);OS (Overall Survival);RCB (Residual Cancer Burden);Safety; | — |
Countries
China
Contacts
Public ContactQi Xiaowei
the First Affiliated Hospital of Army Medical University, PLA
Outcome results
None listed