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Идёт набор NCT06754059

Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC

— 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: Pyrotinib.
Кому может быть актуально
Состояния в реестре: HER2-positive Breast Cancer. Базовые параметры: 18 лет — 70 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
Китай
Следующий шаг
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Официальное название

A Single-arm, Multicenter, Real-world Observational Study of Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC

Обзор

A single-arm, multicenter, real-world observational study of pyrotinib combined with trastuzumab for maintenance therapy after first-line TH (P) therapy for HER2+ABC

Подробное описание

In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles; Single-arm, multicenter, real-world observational studies using endocrine therapy + pyrrotinib + trastuzumab in patients with HR+, and maintenance therapy after first-line TH (P) therapy for CNS events (if non-CNS recurrent, progressive events occur and the investigator decides to change the follow-up regimen). To evaluate the effect of pyrrotinib combined with trastuzumab in maintaining treatment phase delay/reduction of brain metastases after first-line TH (P) therapy for advanced breast cancer with HER-2 positivity, the incidence of first progression of brain metastases was used as the primary endpoint.

Вмешательства

  • Препарат Pyrotinib
    In this study, after at least 4 cycles of taxoid chemotherapy combined with trastuzumab ± pertuzumab, the evaluation result reached SD, CR or PR, and capecitabine combined with pyrotinib + trastuzumab was given successively in the later period (capecitabine was used for 4-6 cycles

Первичные конечные точки

  • Incidence of brain metastases [Срок оценки: through study completion, an average of 2 year]
Вторичные конечные точки (3)
  • ORR [Срок оценки: 24 month]
  • PFS [Срок оценки: through study completion, an average of 2 year]
  • OS [Срок оценки: through study completion, an average of 3 year]

Критерии участия

Критерии включения

  • Age: 18-70 years old, female;
  • Pathological examination confirmed HER-2 positive invasive breast cancer; Her2-positive is defined as >10% of tumor cells with an immunohistochemical (IHC) score of 3+ or in situ hybridization (ISH) results as HER2 gene amplification. A positive HER2 should be confirmed by the pathology department of the participating center of this study.) Imaging examination confirmed recurrent/metastatic breast cancer;
  • Patients with recurrence or metastasis more than 1 year after trastuzumab treatment, or newly diagnosed stage IV breast cancer;
  • ECOG score is 0-1;
  • Expected survival ≥6 months;
  • Normal function of major organs;
  • 1\) Blood routine • ANC≥1.5×109/L; • PLT≥90×109/L; • Hb≥90 g/L; 2) Blood biochemistry • TBIL≤1.5×ULN; • ALT and AST≤2 x ULN; For patients with liver metastases, ALT and AST≤5× ULN; • BUN and Cr ≤ 1.5×ULN and creatinine removal rate ≥ 50 mL/min; 3) Heart color ultrasound • LVEF≥50%;
  • The researcher believes that the subject is likely to benefit;
  • Voluntarily participate in the study and sign the informed consent

Критерии исключения

  • Head MRI or head CT confirms the presence of brain metastases;
  • Have multiple factors affecting oral medication (history of gastrointestinal surgery, inability to swallow, chronic diarrhea, intestinal obstruction);
  • Study patients allergic to drugs and excipients;
  • Suffering from mental illness or psychotropic substance abuse, unable to cooperate;
  • Pregnant or lactating women;
  • Participated in clinical trials within 4 weeks;
  • Participants considered unsuitable for inclusion by the researchers.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Китай · 1 центр
  • Fujian Union Medical College Hospital — Фучжоу

Идентификаторы

NCT: NCT06754059 · Fujian union BC-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗