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RECRUITING
NCT07679360
PHASE3

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.

View on ClinicalTrials.gov

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

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.

Locations (1)

Cancer Hospital of Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China