NCT07111832RecruitingPhase 3
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 · Last updated 18 Dec 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 1 Aug 2025
- Start date
- 20 Aug 2025
- Primary completion date
- Mar 2028
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT07111832
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 400
- From 20 Aug 2025 to the primary completion date, Mar 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
- Have undergone other anti-tumor treatment within 4 weeks before the first dose.
- Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.
Other illness
- Have other malignancies within the past 5 years.
- A history of immunodeficiency.
- Clinically significant cardiovascular diseases.
- Known or suspected interstitial lung disease.
- Known hereditary or acquired bleeding tendency.
- Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
Lab values
- Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.
Other
- Presence with uncontrollable third space effusion.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Cancer hospital Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.