A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer

Официальное название

A Phase III, Multicenter, Randomized, Open-Label Parallel-Controlled Study of Trastuzumab Rezetecan (SHR-A1811) in Combination With Adebrelimab (SHR-1316) Versus Investigator's Choice of Therapy in Subjects With Primary Triple Negative Breast Cancer Who Have Residual Invasive Disease Following Neoadjuvant Therapy

Обзор

It is a randomized, open label, positive drug controlled, multicenter design Phase III clinical trial, aims to compare the efficacy and safety of SHR-A1811 combined with Adebrelimab and the treatment selected by the researchers in the adjuvant treatment of triple negative breast cancer with invasive residual cancer after neoadjuvant treatment, and to explore the PK characteristics and immunogenicity of SHR-A1811 and Adebrelimab.

Вмешательства

• Препарат Trastuzumab Rezetecan for Injection
  Trastuzumab Rezetecan for Injection.
• Препарат Adebrelimab Injection
  Adebrelimab Injection.
• Препарат Capecitabine tablets
  Capecitabine Tables.
• Препарат Pembrolizumab injection
  Pembrolizumab Injection.

Первичные конечные точки

• Invasive disease-free survival (iDFS) [Срок оценки: Until study completion, assessed up to approximately 5 years.]

Вторичные конечные точки (5)

• Disease-free survival (DFS) [Срок оценки: Until study completion, assessed up to approximately 5 years.]
• Overall survival (OS) [Срок оценки: Until study completion, assessed up to approximately 5 years.]
• DRFI (Distant recurrence-free interval) [Срок оценки: Until study completion, assessed up to approximately 5 years.]
• Adverse events (AEs) [Срок оценки: Until study completion, assessed up to approximately 2 years.]
• Serious adverse events (SAEs) [Срок оценки: Until study completion, assessed up to approximately 3 years.]

Критерии участия

Критерии включения

• Pathologically confirmed invasive triple negative breast cancer.
• Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.
• Previous neoadjuvant therapy must meet the requirements of the protocol.
• Has received radical surgery for breast cancer.
• ECOG PS 0\~1.
• Adequate organ functions.
• Women of childbearing potential must be willing to use highly effective form of contraception.

Критерии исключения

• Stage IV metastatic breast cancer.
• Previous invasive breast cancer or ductal carcinoma in situ.
• Bilateral breast cancer.
• Any clinical evidence indicating the exist of recurrent diseases after surgery.
• History of other malignancy within the last 5 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ.
• Previously received antibody coupled drug (ADC) therapy with topoisomerase inhibitors as effective payloads.
• Previously received HER2 targeted therapy.
• Active or previously recorded autoimmune or inflammatory diseases.
• History of immunodeficiency.
• Participants with known or suspected interstitial pneumonia.
• Presence of active Hepatitis B.
• Known to have active tuberculosis infection.
• Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs for treatment.
• Within the 6 months prior to randomization, there was a history of myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, ≥ Grade 2 supraventricular or ventricular arrhythmias, and any grade of ventricular fibrillation.
• Known allergy to any investigational drug or its excipients.
• Other medical conditions that would interfere with study participation or follow-up.

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

• Cancer Hospital of Chinese Academy of Medical Sciences — Пекин

Идентификаторы

NCT: NCT07679360 · SHR-A1811-318

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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