NCT07111832 A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
| NCT ID | NCT07111832 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| Condition | PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-08-20 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 400 participants in total. It began in 2025-08-20 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07111832 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07111832 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 400 participants.
Is NCT07111832 currently recruiting?
Yes, NCT07111832 is actively recruiting participants. Contact the research team at tingting.lei.tl6@hengrui.com for enrollment information.
Where is the NCT07111832 trial being conducted?
This trial is being conducted at Beijing, China, Shanghai, China.
Who is sponsoring the NCT07111832 clinical trial?
NCT07111832 is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.. The trial plans to enroll 400 participants.
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