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This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year.
This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk T1N0M0 early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year. The low-risk population defined in this study includes the IM subtype with abundant stromal tumor-infiltrating lymphocytes, or the LAR subtype with low ki-67 proliferation, or elderly patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capecitabine | Experimental | capecitabine metronomic therapy for one year |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Capecitabine 650mg/m2, bid, p.o for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| RFS | recurrence free survival | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| iDFS | invasive disease-free survival | 3 years |
| DRFS | distant relapse-free survival | 3 years |
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Inclusion Criteria:
8)The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhimin C Shao | Contact | 02164175590 | zhimingshao@yahoo.com | |
| Yin Liu | Contact | 02164175590 | liuyinfudan@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| breast cancer institute of Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| DFS | disease-free survival | 3 years |
| OS | overall survival | 3 years |
| adverse events | adverse events according to CTCAE 5.0 | 3 years |
| PRO | patient reported outcome | 3 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |