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This review will evaluate the efficacy and safety of SHR1210 (Camrelizumab) and antivascular drug(Famitinib) in combination with anthracyclines/taxane-based adjuvant chemotherapy (carrelizumab + FAM + EC-P) compared with conventional chemotherapy regimens (dose-intensive epirubicin and cyclophosphamide, sequential paclitaxel, or EC-P) in patients with early-stage high-risk TNBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm-A | Experimental | SHR1210 (carrelizumab): 200 mg in combination with chemotherapy (described below) intravenously (IV), Q2W, and famitinib (10 mg) orally once daily (QD). This was followed by maintenance therapy with SHR1210 (carrelizumab) (200 mg, IV every 2 weeks [Q2W]) and famitinib (10 mg) orally once daily (QD) to complete treatment with a total duration of 1 year from the first dose. Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel(80 mg/m2)or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks. |
|
| Arm-B | Sham Comparator | Chemotherapy: Intensive intravenous dose of epirubicin (80-90 mg/m2) + IV cyclophosphamide (600 mg/m2) repeated administration of Q2W for a total of 4 doses, followed by (IV) paclitaxel(80 mg/m2)or albumin-paclitaxel(100 mg/m2) once weekly (QW) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epirubicin,cyclophosphamide,paclitaxel,Carrelizumab | Drug | Conventional chemotherapy in combination with carrelizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| iDFS | invasive disease-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| DDFS | distant disease-free survival | 5 years |
| OS | overall survival | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin Shao, MD,PhD | Contact | +86-021-64175590 | 88700 | 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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| epirubicin,cyclophosphamide,paclitaxel | Drug | Conventional chemotherapy |
|
| 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 |
|---|---|
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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