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Идёт набор NCT06035679

Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

Без фазы С лечением Breast Cancer Female

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 and Trastuzumab.
Кому может быть актуально
Состояния в реестре: Breast Cancer Female. Базовые параметры: 18 лет — 75 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective, Single-center, Observational Clinical Study of Pyrotinib Combined With Trastuzumab and Chemotherapy Neoadjuvant Therapy for HER2-positive Breast Cancer

Обзор

This study is a prospective, single-center, observational clinical study, The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.

Подробное описание

This study is a prospective, single-center, observational clinical study,Which plan to be enroll 30 patients with HER2-positive early breast cancer receive pyrotinib combined with trastuzumab and chemotherapy neoadjuvant therapy. The primary endpoint was the total pathological complete response rate (tpCR) , The objection was to observe the treatment of pyrotinib combined with trastuzumab and neoadjuvant chemotherapy Efficacy of Stage II-III breast cancer and observation of the efficacy of step-down neoadjuvant therapy for HER2-positive stage T1cN0M0 breast cancer.

Вмешательства

  • Препарат Pyrotinib and Trastuzumab
    Small and large molecules combined with chemotherapy for neoadjuvant treatment of HER2-positive breast cancer

Первичные конечные точки

  • tpCR [Срок оценки: at surgery]

Критерии участия

Критерии включения

  • Female patients aged 18-75 years;
  • Her2-positive breast cancer confirmed by pathology;
  • invasive breast cancer confirmed by histology, Tumor stage: early stage (T1c-3, N0-1, M0) or locally advanced stage (T2-4, N2, N3, M0);
  • ECOG PS: 0-1 score;
  • Plan to undergo the final surgical removal of breast cancer, i.e. breast conserving surgery or total mastectomy, sentinel lymph node (SN) biopsy or axillary lymph node dissection (ALND)
  • Normal function of major organs means that the following criteria are met:

(1) Blood test neutrophil (ANC) >=1.5x10\^9/L; Platelet count (PLT) >=90x10\^9/L; Hemoglobin (Hb) >=90g/L; (2) Total bilirubin (TBIL) <=1.5 upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=1.5xULN; Alkaline phosphatase <=2.5xULN; Urea nitrogen (BUN) and creatinine (Cr) <=1.5xULN; (3) Left ventricular ejection fraction (LVEF) >=55%; (4) The QT interval (QTcF) corrected by Fridericia method was less than 470msec in 12-lead ECG; 7. For women who have not undergone menopause or surgical sterilization: consent to abstinence or use an effective contraceptive method (during treatment and for at least 7 months after the last dose in the study treatment); 8. Volunteer to participate in this study, sign the informed consent, have good compliance and be willing to cooperate with follow-up.

Критерии исключения

  • Known allergic history of the drug components of this protocol;
  • Previous or co-existing other malignant tumors, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
  • Participated in clinical trials of other antitumor drugs within four weeks;
  • Stage IV (metastatic) breast cancer;
  • Multiple factors affecting oral medication (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction);
  • A history of congestive heart failure (CHF) or uncontrolled heart disease (angina, arrhythmia, hypertension);
  • Patients with active infection and severe mental illness;
  • Pregnant or lactating patients;
  • Patients with allergies or known history of allergies to the drug components of this protocol; A history of immunodeficiency, including being HIV positive, or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Concomitant diseases that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • The First Affiliated Hospital of Fujan Medical University — Фучжоу

Идентификаторы

NCT: NCT06035679 · OBU-BC-II-95

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗