Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the Opportune Administration of Nab-paclitaxel in the First Line Treatment Strategy, Camrelizumab and Famitinib with/without Nab-paclitaxel, of Patients with Unresectable Locally Advanced or Metastatic Immunomodulatory Triple Negative Breast Cancer.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab plus Famitinib with/without nab-palitaxel | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Camrelizumab plus Famitinib with/without nab-Palitaxel | Drug | After enrollment confirmed, the regimen of Camrelizumab Combined with Famitinib will be conducted for 2 cycles (8 weeks). Patients of CR or PR after 2 cycles (8 weeks) will enter dual-therapy maintenance phase until disease progression and will be recorded as PFS-1α. Patients of PD after 2 cycles (8 weeks) will be recorded as PFS-1β. Patients of SD with 2 cycles of dual therapy wlii receive triple therapy regimen: Camrelizumab and Famitinib with nab-Paclitaxel. |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression Free Survival | max 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective Response Rate according to RECIST 1.1 | 8 WEEKS |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ZHONGHUA WANG, MD | Contact | +86 021-6417559 | zhonghuawang95@hotmail.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center Shanghai, China, 200032 | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C000631724 | camrelizumab |
Not provided
Not provided
Not provided