Actively Recruiting
A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-12-18
400
Participants Needed
2
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years old
- Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer
- Expected survival of at least 12 weeks
- Adequate kidney and liver function
- Voluntarily signed informed consent to join the study
You will not qualify if you...
- Active central nervous system metastases untreated by surgery or radiotherapy
- Other cancers diagnosed within the past 5 years
- Uncontrollable third space effusion
- Anti-tumor treatment within 4 weeks before starting this study
- History of immunodeficiency
- Significant heart diseases
- Known or suspected interstitial lung disease
- Known hereditary or acquired bleeding disorders
- Unresolved toxicities from prior anti-cancer treatments above Grade 1
- Allergies to study drugs or humanized monoclonal antibodies
- Other severe physical or mental disorders or significant lab abnormalities
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Cancer Hospital，Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
T
Tingting Lei
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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