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The study is being conducted to evaluate the tolerability, safety and efficacy of SHR-1210 in combination with Apatinib and Fluzoparib in subjects with recurrent and metastatic triple negative breast cancer
Drug: SHR-1210 + Apatinib +Fluzoparib SHR-1210 will be administered as an intravenous infusion, Apatinib tablets will be given orally, Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.
Treatment group : PD-1 antibody SHR-1210 combination with apatinib and fluzoparib
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1210 + Apatinib +Fluzoparib | Experimental | SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1210 + Apatinib +Fluzoparib | Drug | SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicity (DLT) | Dose Limiting Toxicity | First cycle (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events and Serious Adverse Events | AEs and SAEs | from the first drug administration to within 90 days for the last SHR-1210 dose |
| Overall Response Rate (ORR) | up to 12 months (approx) from the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
only female
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| Name | Affiliation | Role |
|---|---|---|
| Huiping Li, PhD | Beijing Cancer Hosptial | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hosptial | Beijing | Beijing Municipality | 100142 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36184642 | Derived | Zhang Q, Shao B, Tong Z, Ouyang Q, Wang Y, Xu G, Li S, Li H. A phase Ib study of camrelizumab in combination with apatinib and fuzuloparib in patients with recurrent or metastatic triple-negative breast cancer. BMC Med. 2022 Oct 3;20(1):321. doi: 10.1186/s12916-022-02527-6. |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| C553458 | apatinib |
| C000722917 | fluzoparib |
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|
| Duration of response (DoR) | up to 12 months (approx) from the start of treatment |
| Disease Control Rate | DCR | up to 12 months (approx) from the start of treatment |
| Progression-Free-Survival | PFS | up to 12 months (approx) from the start of treatment |
| 12-months overall survival rate | 12-months overall survival rate | From the start of treatment to 1 year |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |