RecruitingPhase 3NCT07111832

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

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


Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

400 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing SHR-A1811 — an antibody-drug conjugate that targets HER2 protein on cancer cells and delivers a chemotherapy payload directly to them — in women with triple-negative breast cancer that has spread or cannot be surgically removed. Triple-negative breast cancer does not respond to hormone therapies, so new options are needed. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have confirmed metastatic or locally advanced unresectable triple-negative breast cancer - Your expected survival is at least 12 weeks - Your liver and kidney function are adequate - You have voluntarily agreed to participate **You may NOT be eligible if...** - You have active, untreated brain metastases - You have had another cancer in the past 5 years - You have severe or uncontrolled fluid buildup in body cavities - You received other anti-cancer treatment within 4 weeks before starting the study drug - You have a history of immune deficiency, significant heart disease, or known lung disease (interstitial lung disease) - You have known allergy to humanized antibody therapies Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSHR-A1811 for Injection

SHR-A1811 for injection.

DRUGSHR-1316 Injection

SHR-1316 injection.

DRUGToripalimab Injection

Toripalimab injection.

DRUGPaclitaxel for Injection

Paclitaxel for injection.


Locations(2)

Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Cancer Hospital,Fudan University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07111832