Neratinib in Extended Adjuvant Treatment for HER2+ Early Breast Cancer With pCR But High-Risk Features: A Hebei Multi-Center Real-World Study

Официальное название

Efficacy and Safety of Neratinib as Extended Adjuvant Therapy in HER2-Positive Early Breast Cancer Patients Who Achieved pCR After Neoadjuvant Therapy But Have High-Risk Factors: A Multi-Center, Real-World Study From Hebei, China

Обзор

Neratinib is an oral, irreversible pan-HER tyrosine kinase inhibitor. Current treatment guidelines recommend neratinib as an extended adjuvant therapy for HER2-positive breast cancer patients to further reduce the risk of recurrence. Even when HER2-positive breast cancer patients achieve pathological complete response (pCR) after neoadjuvant therapy, those with high-risk factors (such as large tumors \[cT3/T4\] or lymph node-positive disease) still face a risk of cancer returning. However, there is limited data on the effectiveness and safety of neratinib in these patients. This study aims to provide real-world evidence on how well neratinib works in high-risk HER2-positive breast cancer patients who achieved pCR, helping to improve treatment strategies for Chinese patients.

Подробное описание

This study is a single-arm prospective study with historical controls as external comparators

Вмешательства

• Препарат Neratinib (HKI-272)
  Sequential neratinib extended adjuvant therapy will be initiated within 6 months after completing standard trastuzumab-based adjuvant therapy, continuing for 1 year. As a real-world non-interventional study, treating physicians will determine neratinib regimens per the prescribing information and current clinical practice. Neratinib Dosing: Standard regimen: 240 mg (6 tablets) once daily with food for 1 year； Dose escalation (to mitigate diarrhea, per latest CSCO Breast Cancer Guidelines and

Первичные конечные точки

• Invasive Disease Free Survival (IDFS) [Срок оценки: From Day 1 of treatment until 2 years after treatment completion]

Вторичные конечные точки (8)

• Disease Free Survival (DFS) [Срок оценки: From Day 1 of treatment until 2 years after treatment completion]
• Overall Survival (OS) [Срок оценки: From Day 1 of treatment until 2 years after treatment completion]
• Distant Disease-free Survival (DDFS) [Срок оценки: From Day 1 of treatment until 2 years after treatment completion]
• Time to distant recurrence [Срок оценки: From Day 1 of treatment until the first distant tumor recurrence or metastasis]
• Cumulative incidence of CNS recurrence [Срок оценки: From Day 1 of treatment until 2 years after treatment completion]
• Incidence of grade ≥3 diarrhea [Срок оценки: From consent to 28 days after last dose]
• Incidence and severity of other adverse events (AEs) [Срок оценки: From consent to 28 days after last dose]
• Treatment patterns of patients [Срок оценки: From Day 1 of treatment until last dose]

Критерии участия

Критерии включения

• Age ≥18 years, female
• Clinical stage ≥cT3 or ≥cN1, regardless of hormone receptor (HR) status
• HER2-positive: HER2 IHC 3+ or IHC 2+ with ISH+
• Achieved pathological complete response (pCR) after neoadjuvant therapy
• Completed 1 year of standard adjuvant therapy (including trastuzumab), with ≤6 months between the last adjuvant treatment and starting neratinib
• No evidence of recurrence or metastatic disease (confirmed by clinical/imaging exams after completing standard adjuvant therapy and before starting neratinib)
• Left ventricular ejection fraction (LVEF) ≥50%
• ECOG performance status 0-1

Критерии исключения

• Hypersensitivity to any component of the investigational drug
• Inability to swallow oral medication
• Participation in another interventional clinical trial within 4 weeks before enrollment, or planned participation during this study
• Use of any investigational drug within 14 days prior to treatment initiation
• Concurrent chemotherapy, radiotherapy, immunotherapy, or biologic therapy for breast cancer
• Severe psychiatric disorders preventing compliance with informed consent, treatment, or follow-up procedures
• Pregnancy, lactation, or plans for pregnancy in the near future
• Other significant medical conditions or laboratory abnormalities that, in the investigator's judgment, make participation unsuitable

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07019272 · 2025KY006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗