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This study is designed to investigate the efficacy and safety of capecitabine versus vinorelbine as a postoperative adjuvant chemotherapy, for high risk breast cancer patients who have pathologic residual cancer cells after the preoperative chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Experimental |
| |
| Vinorelbine | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine, Oral, 500 Mg | Drug | 1250mg/m2,d1-d14,q3w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival(DFS) | To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival(OS) | To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm. | 5 years |
| medicine safety | To determine the percentage of disease-free survival (DFS) for the capecitabine monotherapy arm or vinorelbine monotherapy arm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhiyong Yu | Jinan | Shandong | China |
|
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D000077235 | Vinorelbine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| Vinorelbine Tartrate Oral |
| Drug |
60mg/m2,d1;d8;q3w |
|
| 5 years |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D014748 | Vinca Alkaloids |
| D046948 | Secologanin Tryptamine Alkaloids |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |