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The survival rate of patients with pathological complete response (pCR) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-pCR patients. Therefore, studies have confirmed that intensive adjuvant therapy for patients with non-pCR after neoadjuvant chemotherapy can further improve the survival of this population. Previous studies have given capecitabine treatment to such patients as standard. However, it is unknown whether capecitabine intensification still has the same status under the premise that most patients receive immunotherapy at the neoadjuvant stage; Whether there are differences in the efficacy and safety of capecitabine standard 6-8 cycle intensive regimen and capecitabine metronomic chemotherapy are practical problems encountered in clinical practice. This study explored the efficacy and safety of 6-8 cycles of full dose capecitabine intensive therapy compared with 1-year capecitabine metronomic chemotherapy in patients with T2 and above and/or lymph node positive early triple negative breast cancer who still had invasive tumor after neoadjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6-8 cycles full dose capecitabine | 6-8 cycles of full dose capecitabine intensive therapy (1250mg/m2, BID,D1-D14,Q3W) |
| |
| 1-year metronomic capecitabine | 1-year capecitabine metronomic chemotherapy (650mg/m2,BID) |
| |
| no other chemotherapy | no other chemotherapy besides neoadjuvant therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capecitabine | Drug | different methods of treatment for capecitabine |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| invasive disease free survival | The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause. | 5 years |
| distant disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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Triple negative patients, non-PCR after neoadjuvant therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuan peng, doctor | Contact | 86+13671287670 | 13671287670@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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Time from study enrollment to distant recurrence and metastasis |
| 5 years |
| breast cancer specific survival | Time from study enrollment to death due to breast cancer | 5 years |
| overall survival | Time from study enrollment to death from any cause | 5 years |
| D012871 |
| Skin Diseases |
| 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 |