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Набор скоро начнётся NCT07019272

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

— Наблюдательное HER2-positive Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Neratinib (HKI-272).
Кому может быть актуально
Состояния в реестре: HER2-positive Breast Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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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)

Открыть это исследование на ClinicalTrials.gov ↗