Stage I-III HER2-positive breast cancer
Conditions
Interventions
group 1:Neratinib treatment
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients must be fully informed and voluntarily sign an informed consent form; 2.Age between 18-75 years old, female; 3.Histologically confirmed diagnosis of HER-2/erbB-2 positive breast cancer, with no evidence of recurrent or metastatic disease based on clinical/radiological assessment; 4.ECOG score = 12 months; 6.Previous anti-cancer treatment regulations: Previously received standard treatment based on trastuzumab, with trastuzumab treatment completion =1.5×10^9/L; Platelet count >=90×10^9/L; Hemoglobin >=90g/L; Total bilirubin (TBIL) =60ml/min/1.73m^2; Left ventricular ejection fraction (LVEF) >=50%; Corrected QT interval by Fridericia's formula (QTcF) <470 milliseconds; International Normalized Ratio (INR) <=1.5 times ULN, Activated Partial Thromboplastin Time (APTT) <=1.5 times ULN; Voluntarily participate in the study, sign the informed consent form, have good compliance, and willingness to cooperate with follow-up work.
Exclusion criteria
Exclusion criteria: 1.Patients with central nervous system metastases or other malignant tumors; 2.Patients with a history of heart disease; 3.Patients who have previously used HER2-targeting tyrosine kinase inhibitors (including lapatinib, pyrotinib, neratinib); 4.Third-space effusions (such as pleural or ascitic fluid) that cannot be controlled by drainage or other methods; 5.Inability to swallow, intestinal obstruction, or other factors affecting drug intake and absorption; 6.Patients with underlying gastrointestinal diseases or a history of biliary tract surgery; 7.Patients with underlying diseases affecting metabolism, or those who need to take the following medications: proton pump inhibitors (PPIs, such as lansoprazole), potent CYP3A4 inhibitors (like ketoconazole), and potent or moderate CYP3A4 inducers; 8.Known allergy to any of the components in this treatment plan; 9.History of immunodeficiency, including HIV-positive status, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 10.Presence of other malignant tumors within the past 5 years (except for cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin); 11.Pregnant or breastfeeding female patients, female patients of childbearing potential with a positive baseline pregnancy test, or female patients of childbearing potential who are unwilling to use effective contraception throughout the trial; 12.Severe concurrent diseases, or any other conditions that the investigator deems unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The trough plasma concentration of neratinib after 5 half-lives when the patient is at steady state; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year iDFS(2-year Invasive Disease-Free Survival);Safety and resistance;Quality of Life (QOL) scoring; | — |
Countries
China
Contacts
Public ContactTingyi Jin
Huashan Hospital, Fudan University
Outcome results
None listed