PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
Investigational drug(s) / intervention(s)
SHR-A1811 for InjectionSHR-1316 InjectionToripalimab InjectionPaclitaxel for Injection
SHR-A1811 for Injection: SHR-A1811 for injection.
SHR-1316 Injection: SHR-1316 injection.
Toripalimab Injection: Toripalimab injection.
Paclitaxel for Injection: Paclitaxel for injection.
Study 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
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Progression free survival (PFS) — An average of 3 year.
Trial sites (2)
Facility
City
Region
Status
Peking University Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Cancer Hospital,Fudan University
Shanghai
Shanghai Municipality
Recruiting
More Suzhou Suncadia Biopharmaceuticals Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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