A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases

Официальное название

SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases: a Prospective，Sigle-arm，Phase II Study

Обзор

A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases

Вмешательства

• Комбинированный продукт SHR-A1811 and radiotherapy
  SHR-A1811:4.8mg/kg radiotherapy: 800cGY\*5

Первичные конечные точки

• The objective response rate of intracranial（IC-ORR） [Срок оценки: 2 years]

Вторичные конечные точки (4)

• Intracranial CNS Progression Free Survival(IC-PFS) [Срок оценки: 2 years]
• Progression Free Survival(PFS) [Срок оценки: 2 years]
• Overall survival(OS) [Срок оценки: 3 years]
• Adverse Events [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Pathologically confirmed HER2 positive (IHC 3+ or IHC 2+/FISH+)or HER2-low(IHC1+ or 2+/FISH-) advanced breast cancer
• Age>18 years.
• newly diagnosed Brain metastases confirmed by enhanced brain MRI. Metastases number less than 6.
• No more than four lines of previous advanced therapy
• Life expectancy of more than 3 months
• There were no known or suspected leptomeningeal brain metastases
• The interval from previous therapy was more than 2 weeks, and acute toxicity from previous therapy had to resolve to grade 1 or less
• The use of mannitol, bevacizumab, or hormone therapy was allowed before enrollment, but the dose was stable for at least a week without the need for an increment
• Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):

Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN) LVEF ≥ 50% QTcF < 480 ms INR≤1.5×ULN，APTT≤1.5×ULN 10.Signed the informed consent form prior to patient entry

Критерии исключения

• Leptomeningeal or hemorrhagic metastases
• previously used T-dxd
• Uncontrolled epilepsy
• Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
• History of allergy to treatment regimens
• Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
• Inability to complete enhanced MRI
• Not suitable for inclusion for specific reasons judged by sponsor -

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06975462 · UH-SHR A1811 and radiotherapy

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗