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The study is being conducted to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics, and immunogenicity of SHR-A1811 combined with capecitabine in treatment of unresectable or metastatic breast cancer with low HER2 expression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-A1811 combined with capecitabine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1811 for injection ; capecitabine | Drug | SHR-A1811 for injection; Capecitabine tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT(Phase I (dose exploration phase) ) [ Time Frame: 21 days after the first administration of each subject ] | 21 days after the first administration of each subject ] | |
| Incidence of AEs(Phase I (dose exploration phase) ) | from Day1 to 40 days after last dose | |
| Incidence of SAEs(Phase I (dose exploration phase) ) | from Day1 to 40 days after last dose | |
| Objective response rate(Phase II (efficacy expansion phase)) | One year after the last subject was enrolled in the group |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response(DoR ) | One year after the last subject was enrolled in the group | |
| Progression Free Survival(PFS) | One year after the last subject was enrolled in the group | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuchao Wu | Contact | +0518-81220121 | shuchao.wu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230000 | China |
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SHR-A1811 combined with capecitabine
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| Objective response rate(Phase I (dose exploration phase)) |
| One year after the last subject was enrolled in the group |
| Incidence of AEs(Phase II (efficacy expansion phase)) | from Day1 to 40 days after last dose |
| Incidence of SAEs(Phase II (efficacy expansion phase)) | from Day1 to 40 days after last dose |
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijng | 100000 | China |
|
| Guangxi Medical University Affiliated Tumor Hospital & Oncology Medical College | Not yet recruiting | Nanning | Guangxi | 530000 | China |
|
| Shantou Central Hospital | Not yet recruiting | Shantou | Guangzhou | 515000 | China |
|
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
|
| The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The First Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
|
| Shandong Cancer Hospital&Institute | Not yet recruiting | Jinan | Shandong | 250000 | China |
|
| Wenzhou People's Hospital | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| 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 |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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