A Clinical Trial of SHR-A1811 in the Treatment of Triple-negative Breast Cancer
Recruiting · NCT07111832 · Interventional (participants receive a specific treatment) · Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
Age range
18 Years to 75 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
2 locations listed.
- Peking University Cancer Hospital - Beijing, Beijing Municipality, China
- Cancer Hospital，Fudan University - Shanghai, Shanghai Municipality, China