A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
Recruiting now · Phase 3
Conditions studied: PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
In brief
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).
Key facts
- Study ID
- NCT07111832
- Run by
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- People needed
- 400
- Starts
- 2025-08-20
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2025-12-18
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-75 years old (including both ends), female.
- Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
- Expected survival ≥ 12 weeks.
- Have adequate renal and hepatic function.
- Patients voluntarily joined the study and signed the informed consent.
You may not qualify if…
- Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
- Have other malignancies within the past 5 years.
- Presence with uncontrollable third space effusion.
- Have undergone other anti-tumor treatment within 4 weeks before the first dose.
- A history of immunodeficiency.
- Clinically significant cardiovascular diseases.
- Known or suspected interstitial lung disease.
- Known hereditary or acquired bleeding tendency.
- Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.
- Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
- Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.
Where it is running
- Peking University Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
- Cancer Hospital，Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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