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The study is being conducted to evaluate the Famitinib with Camrelizumab plus treatment of physician's choice (TPC) versus Camrelizumab plus TPC in Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Famitinib in Combination With Camrelizumab and TPC |
|
| B | Active Comparator | Combination With Camrelizumab and TPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib | Drug | TKI |
| |
| Camrelizumab |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | time to progressive disease (according to RECIST1.1) | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1) | max 6 months |
| DoR | Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao | Contact | 86-021-64175590 | 8888 | zhimingshao@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast cancer institute of Fudan University Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Drug |
PD1 inhibitor |
|
| nab-Palitaxel/Capecitabine/Eribulin Mesylate/Carboplatin | Drug | TPC |
|
| max 6 months |
| CBR | The percentage of subjects with CR+PR+SD and last more than 24 weeks in all of the participants. | max 6 months |
| OS | time to death due to any cause | approximately 3 years |
| 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 |
|---|---|
| C584390 | famitinib |
| C000631724 | camrelizumab |
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