A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
NCT ID: NCT07111832
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
400 participants
INTERVENTIONAL
2025-08-20
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-A1811 and SHR-1316 Group
SHR-A1811 for Injection
SHR-A1811 for injection.
SHR-1316 Injection
SHR-1316 injection.
Toripalimab and Nab-paclitaxel Group
Toripalimab Injection
Toripalimab injection.
Paclitaxel for Injection
Paclitaxel for injection.
Interventions
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SHR-A1811 for Injection
SHR-A1811 for injection.
SHR-1316 Injection
SHR-1316 injection.
Toripalimab Injection
Toripalimab injection.
Paclitaxel for Injection
Paclitaxel for injection.
Eligibility Criteria
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Inclusion Criteria
2. Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
3. Expected survival ≥ 12 weeks.
4. Have adequate renal and hepatic function.
5. Patients voluntarily joined the study and signed the informed consent.
Exclusion Criteria
2. Have other malignancies within the past 5 years.
3. Presence with uncontrollable third space effusion.
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose.
5. A history of immunodeficiency.
6. Clinically significant cardiovascular diseases.
7. Known or suspected interstitial lung disease.
8. Known hereditary or acquired bleeding tendency.
9. Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.
10. Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
11. Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.
18 Years
75 Years
FEMALE
No
Sponsors
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Suzhou Suncadia Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Cancer Hospital，Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Huiping Li
Role: primary
Zhimin Shao
Role: primary
Other Identifiers
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SHR-A1811-313
Identifier Type: -
Identifier Source: org_study_id