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RECRUITING
NCT07111832
PHASE3

A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer

Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is to evaluate the progression-free survival (PFS) of SHR-A1811 combined with SHR-1316 in the first-line treatment of PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer with Toripalimab combined with Nab-paclitaxel, as assessed by blinded independent central review (BICR).

Official title: A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2025-08-20

Completion Date

2028-12

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DRUG

SHR-A1811 for Injection

SHR-A1811 for injection.

DRUG

SHR-1316 Injection

SHR-1316 injection.

DRUG

Toripalimab Injection

Toripalimab injection.

DRUG

Paclitaxel for Injection

Paclitaxel for injection.

Locations (2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Cancer Hospital,Fudan University

Shanghai, Shanghai Municipality, China