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
1 other identifier
interventional
400
1 country
2
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Aug 2025
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2025
CompletedFirst Posted
Study publicly available on registry
August 8, 2025
CompletedStudy Start
First participant enrolled
August 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
December 18, 2025
December 1, 2025
2.5 years
August 1, 2025
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
An average of 3 year.
Secondary Outcomes (6)
Overall response (OS) rate evaluated by investigators
An average of 3 year.
Clinical benefit rate (CBR) evaluated by investigators
An average of 3 year.
Duration of response (DoR) evaluated by investigators
An average of 3 year.
Progression-free survival on next-line therapy (PFS2) evaluated by investigators
An average of 3 year.
Adverse events (AEs)
An average of 3 year.
- +1 more secondary outcomes
Study Arms (2)
SHR-A1811 and SHR-1316 Group
EXPERIMENTALToripalimab and Nab-paclitaxel Group
ACTIVE COMPARATORInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Cancer Hospital，Fudan University
Shanghai, Shanghai Municipality, 200032, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2025
First Posted
August 8, 2025
Study Start
August 20, 2025
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
December 18, 2025
Record last verified: 2025-12