A Study of Trastuzumab Rezetecan in Combination With Adebrelimab Versus Investigator's Choice of Therapy in Subjects With Residual Triple Negative Breast Cancer
NCT07679360 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000
Last updated 2026-07-01
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.
Conditions
Interventions
- DRUG
-
Trastuzumab Rezetecan for Injection
Trastuzumab Rezetecan for Injection.
- DRUG
-
Adebrelimab Injection
Adebrelimab Injection.
- DRUG
-
Capecitabine tablets
Capecitabine Tables.
- DRUG
-
Pembrolizumab injection
Pembrolizumab Injection.
Sponsors & Collaborators
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2030-12-31
- Completion
- 2032-12-31
Countries
- China
Study Locations
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