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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Trastuzumab Rezetecan for Injection.
Adebrelimab Injection.
Capecitabine Tables.
Pembrolizumab Injection.
Cancer Hospital of Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGInvasive disease-free survival (iDFS)
Time frame: Until study completion, assessed up to approximately 5 years.
Disease-free survival (DFS)
Time frame: Until study completion, assessed up to approximately 5 years.
Overall survival (OS)
Time frame: Until study completion, assessed up to approximately 5 years.
DRFI (Distant recurrence-free interval)
Time frame: Until study completion, assessed up to approximately 5 years.
Adverse events (AEs)
Time frame: Until study completion, assessed up to approximately 2 years.
Serious adverse events (SAEs)
Time frame: Until study completion, assessed up to approximately 3 years.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.