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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| CSPC Ouyi Pharmaceutical Co., Ltd. | INDUSTRY |
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This is a multi-center , open-lable clinical trial. Triple-negative breast cancer (TNBC) is a term applied to breast cancer cases that have <1% expression of the estrogen receptor (ER) and the progesterone receptor (PR) and do not over express HER2. TNBC is diagnosed in 15-20% of breast cancer cases and tends to occur in younger women and have biologically more aggressive high grade disease.
The purpose of this study is to assess the efficacy and safety of the following two combinations: i) nab-paclitaxel+carboplatin; ii) nab-paclitaxel+capecitabine in subjects with advanced TNBC and up to one prior line of systemic treatment for metastatic disease. Maintenance therapy with capecitabine after completion of combination chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nab-paclitaxel + Carboplatin | Experimental | Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles; Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity; |
|
| Nab-paclitaxel + Capecitabine | Experimental | Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles; Maintenance therapy: Capecitabine 1000 mg/m^2 bid, d1-14; every 21 days, until disease progression or intolerable toxicity; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nab-paclitaxel + Carboplatin | Drug | nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Up to disease progression or death due to any cause | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS rate for 6 cycles | From the date of randomization to the end of 6 cycles | At the end of Cycle 6 (each cycle is 21 days) |
| Objective response rate (ORR) | To evaluate the Overall Response Rate of patients with advanced triple-negative breast cancer |
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Inclusion Criteria:
Exclusion Criteria:
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cuizhi Geng, M.D. | Contact | 0311-6669 6310 | gengcuizhi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zefei Jiang, M.D. | Beijing 302 Hospital | Study Chair |
| Cuizhi Geng, M.D. | Hebei Medical University Fourth Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050011 | China |
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| Nab-paclitaxel + Capecitabine | Drug | Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles; |
|
| 3 years |
| Overall survival (OS) | To evaluate the overall survival of patients with advanced triple-negative breast cancer | 3 years |
| Adverse events (AE) | To evaluate the adverse events of patients with advanced triple-negative breast cancer | 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 |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D016190 | Carboplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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