Clinical trial · Interventional
A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
A Phase III, Multicenter, Randomized, Open-label, Active-controlled Study of SHR-A1811 Plus SHR-1316 Versus Toripalimab Plus Nab-paclitaxel in PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel for Injection | Drug | Paclitaxel | ALIAS |
| SHR-1316 Injection | Drug | — | UNRESOLVED |
| SHR-A1811 for Injection | Drug | — | UNRESOLVED |
| Toripalimab Injection | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SHR-A1811 and SHR-1316 Group
- interventionNames
- Drug: SHR-A1811 for Injection
- Drug: SHR-1316 Injection
- type
- ACTIVE_COMPARATOR
- label
- Toripalimab and Nab-paclitaxel Group
- interventionNames
- Drug: Toripalimab Injection
- Drug: Paclitaxel for Injection
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- An average of 3 year.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available