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Early triple negative breast cancer patients who do not achieve pathologic complete response after neoadjuvant chemotherapy with or without immunotherapy have bad prognosis. ctDNA effectively identified patients with highest relapse risk.
This trial aims to explore whether the combination of anlotinib, immunotherapy and capecitabine could improve the outcome of this subgroup of high relapse risk patients compared with investigator's choice of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Anlotinib 8mg qd POļ¼357days Benmelstobart 200mg i.v. Q3W or immunotherapy continued as in the NAC. Capecitabine 1000 ę 1250 mg/m2 BID day1-14 |
|
| B | Active Comparator | Investigator's choice. If immunotherapy was used in the NAC setting, it was required to be used after NAC for up to 1 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib , | Drug | Anlotinib 8mg qd POļ¼357days |
| |
| Benmelstobart |
| Measure | Description | Time Frame |
|---|---|---|
| iDFS | invasive disease free survival | from randomization to any of the following events: local or distant relapse; contralateral breast caner, death of any causeļ¼assessed up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| dDFS | distant disease free survival | from randomization to any of the following events: distant relapse; contralateral breast caner, death of any causeļ¼assessed up to 36 months |
| OS | overall survival |
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Inclusion Criteria:
Exclusion Criteria:
-
Gender identity is based on self-representation
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital | Recruiting | Guangzhou | Guangodng | China |
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| Drug |
Benmelstobart 200mg i.v. Q3W |
|
| Capecitabine | Drug | Capecitabine 1000 or 1250 mg/m2 BID day1-14 |
|
| from randomization to any of the following events: death of any causeļ¼assessed up to 120 months |
| ctDNA clearance | the rate of patients whose ctDNA are positive after surgery and turns negative after boost therapy | From the time when post-operative ctDNA is tested to be positive to the time surveillence ctDNA turns negative, assessed up to 60 months |
| ID | Term |
|---|---|
| D001943 | 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 |
|---|---|
| C000625192 | anlotinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| 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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