Early Breast Cancer
Conditions
Interventions
Observation group:None
Sponsors
The First Hospital of China Medical University; Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Age >=18 years (no upper limit), female 2: Patients diagnosed with EBC (stage?-?) through clinical diagnosis, histopathology, or cytology, regardless of hormone receptor (HR) status; 3:HER2 positive: HER2 IHC3+ or IHC2+ and ISH+ 4:Before conducting any specific research operation, the informed consent form has been signed. 5:Postoperative (including neoadjuvant postoperative) standard adjuvant treatment for 1 year, with the interval between the last adjuvant treatment and the initiation of neratinib adjuvant intensification therapy being =pT2 or >=pN1; b. Postoperative pathological stage =cT3 or >=cN2. 7: Clinical or imaging investigations (during the period of using neratinib for adjuvant intensification therapy after completing standard adjuvant treatment) show no evidence of recurrence or metastatic disease. 8: Left ventricular ejection fraction (LVEF) >=50% as shown by echocardiography (ECHO) or multi-gated acquisition (MUGA) 9: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
Exclusion criteria
Exclusion criteria: 1: Any contraindications for neratinib therapy specified in the summary of product characteristics (smPC) 2: Individuals allergic to any component of the Investigational Product 3: Before or at the start of the study, clinical diagnosis or imaging suggests local recurrence or metastasis. 4:Patients who participated in, are participating in, or are about to participate in other interventional clinical trials within 4 weeks prior to enrollment 5:Patients who have taken the Investigational Product within 14 days of starting therapy 6:Patients undergoing chemotherapy, radiotherapy, immunotherapy, or biological drug product treatment for breast cancer 7:Patients with severe mental disease who are unable to cooperate in completing informed consent, therapy, and physical follow-up content 8:Pregnancy, lactation, and those planning to conceive in the near future 9:Patients deemed unsuitable for participation in this study by the investigator due to major illness, laboratory test abnormalities, or other reasons 10:Patients unable to swallow drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year Invasive Disease-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-Free Survival;Incidence of grade >=3 diarrhea;Overall Survival;Distant Disease-Free Survival;Recurrence-Free Interval;Distant Recurrence-Free Interval;Cumulative incidence of central nervous system recurrence;Severity and incidence of other adverse events;Patient-reported outcomes of health-related quality of life;Prior treatment patterns in patients; | — |
Countries
China
Contacts
Public ContactYingying Xu; Chang Gong
The First Hospital of China Medical University; Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Outcome results
None listed