Breast Cancer
Conditions
Interventions
Control group :trastuzumab, docetaxel, and carboplatin
Trial group:trastuzumab, docetaxel, carboplatin and pyrotinib
Sponsors
The First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female breast cancer patients at the age of >= 18 years and 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification; 5. Known state of hormone receptors and progesterone receptor is known; 6. The functional level of the main organs must meet the following requirements (no blood transfusion and no use of leukocytes- and platelets-raising drugs in 2 weeks before screening): absolute neutrophil count (ANC) >= 1.5 × 10^9/L, platelet (PLT) count >= 90 × 10^9/L, hemoglobin (Hb) >= 90 g/L, total bilirubin (TBIL) = upper limits of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 1.5 × ULN, alkaline phosphatase = 2.5 x ULN, blood urea nitrate (BUN) and creatinine (Cr) 55%, corrected QT interval by Fredericia (QTcF) < 470 ms; 7. For women who are not menopausal or who have not undergone surgical sterilization, they agree to stay abstinent or use effective contraceptive methods during the whole treatment period and for at least 7 months after the last administration during the study period; 8. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up.
Exclusion criteria
Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Patients who had received antineoplastic therapy or radiotherapy for any malignant tumors, but excluding cured cervical cancer in situ, basal cell carcinoma or squamous cell carcinoma; 3. Patients who are receiving anti-cancer therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy or immunotherapy; 4. Those who had undergone major breast cancer-free operations within 4 weeks before randomization or who had not yet fully recovered from such surgeries; 5. Severe cardiac diseases or discomforts; 6. Inability to swallow, intestinal obstruction or other factors affecting drug use and absorption; 7. Anyone with known history of allergy to the components of study drugs; history of immunodeficiency, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation; 8. Female patients during pregnancy and lactation, those with fertility and providing positive baseline pregnancy test results, or those of childbearing age who are unwilling to take effective contraceptive measures throughout the trial; 9. Patients with severe concomitant diseases or other complications that interfere with planned treatment or in any other case considered unsuitable by the researchers to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathologic complete response (tpCR) rate.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Eastern Cooperative Oncology Group (ECOG) performance status;Routine blood test;Biochemical indicators;Routine urine test; | — |
Countries
China
Contacts
Public ContactFeng Jin
The First Hospital of China Medical University
Outcome results
None listed