PD-L1-positive Locally Recurrent Unresectable or Metastatic Triple-negative Breast Cancer
Conditions
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).
Interventions
SHR-A1811 for injection.
SHR-1316 injection.
DRUGToripalimab Injection
Toripalimab injection.
Paclitaxel for injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | An average of 3 year. |
Secondary
| Measure | Time frame |
|---|---|
| Clinical benefit rate (CBR) evaluated by investigators | An average of 3 year. |
| Duration of response (DoR) evaluated by investigators | An average of 3 year. |
| Overall response (OS) rate evaluated by investigators | An average of 3 year. |
| Adverse events (AEs) | An average of 3 year. |
| Serious adverse events (SAEs) | An average of 3 year. |
| Progression-free survival on next-line therapy (PFS2) evaluated by investigators | An average of 3 year. |
Countries
China
Contacts
Primary ContactTingting Lei
Outcome results
None listed