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A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Summary
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2026-09-02
Completion Date
2032-12
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
Trastuzumab Rezetecan for Injection
Trastuzumab Rezetecan for Injection.
Adebrelimab Injection
Adebrelimab Injection.
Capecitabine tablets
Capecitabine Tables.
Pembrolizumab injection
Pembrolizumab Injection.
Locations (1)
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China