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Набор скоро начнётся NCT07560475

Exploratory Study of SHR-A1811 Via Different Administration Routes in Patients

Фаза II С лечением HER2positive Advanced Breast Cancer HER2 + 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: SHR-A1811, SHR-A1811, SHR-A1811.
Кому может быть актуально
Состояния в реестре: HER2positive, Advanced Breast Cancer, HER2 + Breast Cancer. Базовые параметры: от 18 лет · Все.
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

Exploratory Study of Efficacy and Safety of Different Administration Routes of SHR-A1811 in Patients With HER2-Positive Advanced Breast Cancer

Обзор

An Exploratory Study on the Efficacy and Safety of Different Administration Routes of SHR-A1811 in the Treatment of HER2-Positive Advanced Breast Cancer

Вмешательства

  • Препарат SHR-A1811
    SHR-A1811 administered weekly
  • Препарат SHR-A1811
    SHR-A1811 administered every two weeks (q2w)
  • Препарат SHR-A1811
    SHR-A1811 administered every three weeks (q3w)

Первичные конечные точки

  • Objective Response Rate (ORR) [Срок оценки: From enrollment until disease progression or up to 2 years]
Вторичные конечные точки (1)
  • Progression-Free Survival (PFS) [Срок оценки: From enrollment until disease progression or up to 2 years]

Критерии участия

Критерии включения

  • Aged ≥ 18 years old.
  • Pathologically confirmed HER2-positive advanced breast cancer. HER2 positivity is defined as IHC 3+ in >10% immunoreactive cells or HER2 gene amplification confirmed by in situ hybridization (ISH), which shall be verified by the pathology department of the participating center.
  • Patients with advanced breast cancer who have received no more than 2 lines of prior systemic therapies.
  • Expected survival time ≥ 4 months.
  • Have at least one measurable lesion per RECIST 1.1 criteria (helical CT scan lesion diameter ≥ 10 mm with slice thickness ≤ 5 mm).
  • Adequate major organ function without blood transfusion.
  • Voluntarily participate in the study, sign informed consent form, with good compliance and willingness to complete follow-up visits.

Критерии исключения

  • Prior treatment with anti-HER2 antibody-drug conjugates (ADC).
  • Known leptomeningeal metastasis or active brain metastasis.
  • A history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma. Malignancies cured solely by surgery more than 5 years prior to enrollment are allowed.
  • Major surgery or severe trauma within 4 weeks before enrollment, or planned major surgery during the study period.
  • Participation in other investigational new drug clinical trials within 4 weeks prior to enrollment.
  • Presence of hereditary bleeding tendency or coagulation disorders.
  • Uncontrolled hypertension with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg despite standard antihypertensive therapy.
  • A history of clinically significant pulmonary diseases, including but not limited to interstitial pneumonia, active pneumonia, pulmonary fibrosis and radiation pneumonitis (excluding asymptomatic post-radiation changes without treatment requirement).
  • A history of severe cardiac diseases or uncontrolled cardiac conditions, including NYHA class II or higher cardiac insufficiency, unstable angina, myocardial infarction within one year, and arrhythmias requiring clinical intervention.
  • Conditions affecting drug intake and absorption, such as dysphagia, chronic diarrhea and intestinal obstruction.
  • Known allergy to any component of the study drugs.
  • Uncontrolled pleural effusion or ascites that cannot be relieved by drainage or other clinical interventions.
  • Severe uncontrolled comorbidities, including immune deficiency disorders (e.g. HIV positivity, history of organ transplantation), active hepatitis B or hepatitis C, and severe ongoing infections requiring systemic anti-infective treatment.
  • Any other conditions considered inappropriate for study enrollment by the investigator.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Tianjin Medical University Cancer Insititute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07560475 · MA-BC-II-145

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗