HER2-positive Breast Cancer
Conditions
Interventions
Experimental Group:Strategy of Reducing Initial Dose Combined with Preventive Management
Sponsors
Xinyang Central Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Women aged 8 years or older; 2. Must be histologically confirmed as HER2-positive early invasive breast cancer (IHC 3+ or FISH/CISH); 3. Must meet one of the following high-risk features: (1) After neoadjuvant therapy, breast and/or axillary lymph nodes did not achieve pathological complete response (pCR); (2) After adjuvant therapy, axillary lymph nodes are positive (>= 1 node); 4. Must have completed a total of at least 9 months of adjuvant trastuzumab +/- pertuzumab therapy; 5. The time interval from the last trastuzumab dose to study enrollment is = 1.5 x 10^9/L; platelet count >= 100 x 10^9/L; hemoglobin >= 90 g/L; (2) Liver function: total bilirubin = 50 mL/min; (4) Heart function: left ventricular ejection fraction (LVEF) >= 50%, and no clinical symptomatic heart failure; 9. Understand and sign an ethics committee-approved informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with breast cancer that has metastasized (stage IV); 2. Previously treated with any tyrosine kinase inhibitors (TKIs) (such as lapatinib, pyrotinib, etc.); 3. Having active, uncontrolled diarrhea or chronic intestinal diseases that may cause diarrhea (like Crohn's disease, ulcerative colitis, malabsorption syndrome); 4. Having severe uncontrolled medical conditions or active infections; 5. Known allergy to neratinib or any of its excipients; 6. Unable to take oral medication (e.g., severe nausea and vomiting, difficulty swallowing, history of major gastric surgery); 7. Requiring long-term use of strong CYP3A4 inhibitors or inducers that cannot be stopped during the study; 8. Need for long-term use of proton pump inhibitors (PPIs) and cannot switch to H2 receptor antagonists or antacids during the study; 9. Any serious lab abnormalities that could interfere with study results, increase patient risk, or affect study completion; 10. Pregnant or breastfeeding women; women of childbearing potential unwilling to use effective contraception during the study and for at least 3 months after the last dose; 11. History of significant neurological or psychiatric disorders, including epilepsy or dementia, with poor compliance and inability to cooperate with the study; 12. Participation in any other interventional clinical study at the same time; 13. Any other conditions that the investigator deems make the patient unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 3 or higher diarrhea during Cycle 1 (28 days) of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event rate; | — |
Countries
China
Contacts
Public ContactZhan Zhixiang
Xinyang Central Hospital
Outcome results
None listed