Adjuvant Trastuzumab Plus Neratinib in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer After Neoadjuvant Trastuzumab Plus Pertuzumab

Exclusion Criteria

• •1. History of local or regional breast cancer recurrence;
• •2. Clinical stage IV (metastatic) breast cancer;
• •3. Bilateral breast cancer;
• •4. History of other malignant tumors within the past 5 years, except for curatively treated cervical carcinoma in situ, basal cell carcinoma, or cutaneous squamous cell carcinoma;
• •5. Prior treatment with pyrotinib, lapatinib, neratinib, or other tyrosine kinase inhibitors; trastuzumab emtansine; or any antitumor biological or immunotherapy;
• •6. Concurrent participation in another clinical trial involving antitumor therapy, including endocrine therapy, bisphosphonate therapy, or immunotherapy;
• •7. Significant cardiac disease, including:
• •* Heart failure or systolic dysfunction (LVEF \< 50%);
• •* Poorly controlled arrhythmias (e.g., atrial tachycardia, significant ventricular arrhythmia, or high-grade atrioventricular block);
• •* Angina requiring antianginal medication;
• •* Clinically significant valvular heart disease;
• •* Electrocardiographic evidence of transmural myocardial infarction;
• •* Poorly controlled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 100 mmHg) despite medication;
• •8. Impaired drug absorption due to dysphagia, intestinal obstruction, or other gastrointestinal disorders;
• •9. History of neurological or psychiatric conditions that may compromise compliance or informed consent;
• •10. Chronic gastrointestinal disorders with predominant diarrhea;
• •11. Known hypersensitivity to any study drug components; history of immunodeficiency (e.g., HIV positivity, congenital or acquired immunodeficiency disorder), or prior organ transplantation;
• •12. Pregnancy, lactation, or positive pregnancy test at baseline in women of childbearing potential;
• •13. Severe comorbidities that may interfere with treatment, including active infections (e.g., hepatitis B, hepatitis C, tuberculosis, syphilis) or any other condition deemed by the investigator to render the patient unsuitable for trial participation.