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The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.
The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA | Experimental | Anlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anlotinib | Drug | Before breakfast, anlotinib hydrochloride capsule was taken on an empty stomach, once a day, 1 tablet (10mg) each time.Continuous oral administration for 2 weeks stopped for 1 week, that is, 3 weeks (21 days) as a treatment cycle, until disease progression or adverse reactions become intolerable.In case of missing medication, confirm that the time before the next medication is less than 12 hours, no refill. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | he ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR) | up to 1 year after the last patient enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause | up to 1 year after the last patient enrolled |
| adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Yuan, doctor | Contact | 18612621749 | sunlight_1985@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Recruiting | Beijing | Beijing Municipality | 100021 | 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 |
|---|---|
| C000625192 | anlotinib |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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|
| Capecitabine | Drug | Capecitabine tablets 1000 mg/m2, twice a day, within 30min after meals, were taken orally for 2 consecutive weeks and stopped for 1 week, i.e., 3 weeks (21 days) as a treatment cycle until disease progression or adverse reactions became intolerable. |
|
Incidence and Severity of adverse events hematologic,hepatotoxicity,Incidence of hypertension,Incidence of proteinuria
| approximately 1.5 years |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | 100021 | China |
|
| 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 |