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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 and SHR-1316 Group | Experimental |
| |
| Toripalimab and Nab-paclitaxel Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 for Injection | Drug | SHR-A1811 for injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | An average of 3 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response (OS) rate evaluated by investigators | An average of 3 year. | |
| Clinical benefit rate (CBR) evaluated by investigators | An average of 3 year. | |
| Duration of response (DoR) evaluated by investigators |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingting Lei | Contact | +86-0518-82342973 | tingting.lei.tl6@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| SHR-1316 Injection |
| Drug |
SHR-1316 injection. |
|
| Toripalimab Injection | Drug | Toripalimab injection. |
|
| Paclitaxel for Injection | Drug | Paclitaxel for injection. |
|
| An average of 3 year. |
| Progression-free survival on next-line therapy (PFS2) 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. |
| Cancer Hospital,Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D007267 | Injections |
| C000656314 | toripalimab |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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