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

NCT07111832 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-12-18

No results posted yet for this study

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).

Conditions

  • PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer

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.

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
2025-08-20
Primary Completion
2028-03-31
Completion
2028-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07111832 on ClinicalTrials.gov