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

This will test whether SHR-A1811 combined with SHR-1316 as first-line therapy helps people with PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer live longer without their cancer getting worse compared with toripalimab plus nab‑paclitaxel.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: Toripalimab
• Locations: 2 sites (Beijing, Beijing Municipality and 1 other locations)
• Trial ID: NCT07111832 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adult women aged 18–75 with pathologically confirmed PD-L1-positive locally recurrent unresectable or metastatic triple-negative breast cancer who meet organ function criteria and have not received recent anti-tumor treatment are the intended candidates.

Not a fit: Patients with active untreated central nervous system metastases, recent other malignancies, uncontrolled third-space effusions, significant cardiac or pulmonary disease, immunodeficiency, bleeding disorders, or known hypersensitivity to the study drugs are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, the combination could extend progression-free survival and offer a new first-line option for PD-L1-positive metastatic triple-negative breast cancer.

How similar studies have performed: Prior trials combining immune checkpoint inhibitors with chemotherapy have improved outcomes in PD-L1-positive metastatic triple-negative breast cancer, but SHR-A1811 and SHR-1316 are newer agents with limited phase 3 evidence to date.

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.

Where this trial is running

Beijing, Beijing Municipality and 1 other locations

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Cancer Hospital，Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Tingting Lei

Conditions: PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer