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

RecruitingPhase 3Ages 18 Years - 75 YearsFemaleSuzhou Suncadia Biopharmaceuticals Co., Ltd.
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age 18-75 years old (including both ends), female. 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: 1. Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy. 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.
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What it tests

  • SHR-A1811 for Injection
  • SHR-1316 Injection
  • Toripalimab Injection
  • Paclitaxel for Injection
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Where

2 sites
Peking University Cancer Hospital
Beijing, China
Cancer Hospital,Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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