SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

Официальное название

A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

Обзор

This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.

Вмешательства

• Препарат SHR-A1811 Injection + Adebrelimab Injection
  Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
• Препарат SHR-A1811 Injection + Adebrelimab Injection
  Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
• Препарат SHR-A1811 Injection
  Drug: SHR-A1811 Injection

Первичные конечные точки

• Total pathological complete response (tpCR: ypT0-is/ypN0) [Срок оценки: At the time of surgery]

Вторичные конечные точки (8)

• Breast pathological complete response (bpCR：ypT0-is) [Срок оценки: At the time of surgery]
• Residual cancer burden (RCB) [Срок оценки: At the time of surgery]
• Best overall response rate (BORR) [Срок оценки: During 18 weeks of the neoadjuvant treatment]
• Overall survival (OS) [Срок оценки: 5 years]
• Disease-free survival (DFS) [Срок оценки: 5 years]
• Event-free survival (EFS) [Срок оценки: 5 years]
• Health-related quality of life (HRQOL) (EORTC QLQ-C30) [Срок оценки: During 18 weeks of the neoadjuvant treatment]
• Health-related quality of life (HRQOL) [Срок оценки: During 18 weeks of the neoadjuvant treatment]

Критерии участия

Критерии включения

• Female patients aged ≥ 18 but ≤ 75 years
• Histologically confirmed to be HR+/HER2-Low invasive breast cancer
• Treatment-naive patients with stage II-III
• Eastern Cooperative Oncology Group (ECOG) score is 0 or 1
• Good level of organ function
• Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits

Критерии исключения

• Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
• Received any other anti-tumor therapy at the same time
• Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
• Stage IV breast cancer
• Not confirmed by histopathology
• With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
• Participated in other drug clinical trials within 4 weeks before enrollment
• Known allergic history of the drug components of this protocol
• History of immunodeficiency
• Clinically significant cardiovascular diseases
• Known or suspected interstitial lung disease
• Active hepatitis and liver cirrhosis
• Known hereditary or acquired bleeding thrombotic tendency
• History of neurological or psychiatric disorders

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shengjing Hospital affiliated to China Medical University — Шэньян

Идентификаторы

NCT: NCT06340230 · BC-NEO-IIT-SHR-A1811-SHR1316

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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