SHR-A1811 plus SHR-1316 as first-line treatment for PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial enrolls adult women with PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer for first-line therapy. Participants will receive SHR-A1811 plus SHR-1316 or toripalimab plus nab‑paclitaxel, with treatments and schedules defined by the protocol. The primary endpoint is progression-free survival as measured by blinded independent central review (BICR), with additional safety and overall survival data collected. Key eligibility requirements include age 18–75, adequate organ function, and no active untreated CNS metastases or recent anticancer therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Cancer Hospital，Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Tingting Lei
• Email: tingting.lei.tl6@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.