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This is a randomized, open-label phase III clinical trial comparing antivascular therapy combined with standard chemotherapy and standard chemotherapy in adjuvant therapy for patients with triple-negative breast cancer, basal-like/Immune suppressed subtype.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm-A | Experimental | BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W + Chemotherapy ddEC-P(described below). This was followed by maintenance therapy with BP102 (10 mg/kg) iv D1 and D15 repeated administration of Q4W to complete treatment with a total duration of 1 year from the first dose. Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. |
|
| Arm-B | Active Comparator | Chemotherapy: ddEC-P (dose-dense Epirubicin and Cyclophosphamide followed by Nab-paclitaxel). Epirubicin (75-100 mg/m2) iv D1 + Cyclophosphamide (600 mg/m2) iv D1 repeated administration of Q2W for a total of 4 doses, followed by Nab-paclitaxel (125 mg/m2) once weekly (QW) for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antivascular therapy | Drug | BP102 (anti VEGFR) |
| |
| Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| iDFS | invasive disease-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| DRFS | distant recurrence 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 | |
|---|---|---|---|---|
| Zhi-Ming Shao, MD, PhD | Contact | +86-021-64175590 | 8808 | zhimingshao@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Drug |
ddEC-P |
|
| AE | adverse effects | 5 years |
| Chongqing Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | 400030 | China |
|
| Fujian Medical University Union Hospital | Recruiting | Fuzhou | Fujian | 350001 | China |
|
| Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Sun Yat-sen University Cancer Center | Recruiting | Guangdong | Guangzhou | 510062 | China |
|
| Affiliated Hospital of Nantong University | Recruiting | Nantong | Jiangsu | 226006 | China |
|
| Northern Jiangsu People's Hospital | Recruiting | Yangzhou | Jiangsu | 225009 | China |
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| The First Hospital of China Medical University | Recruiting | Shenyang | Liaoning | 110002 | China |
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| Liaoning Cancer Hospital & Institute | Recruiting | Shenyang | Liaoning | 110801 | China |
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| Breast cancer institute of Fudan University Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
|
| Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | 200233 | China |
|
| Shanghai First Maternity and Infant Hospital | Recruiting | Shanghai | Shanghai Municipality | 201204 | China |
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| The First Affiliated Hospital of Xi'an Jiaotong University | Recruiting | Xi’an | Shanxi | 710061 | China |
|
| West China Hospital of Sichuan University | Recruiting | Chengdu | Sichuan | 610041 | China |
|
| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | China |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative 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 |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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