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The purpose of this study is to assess the efficacy and safety of patients who receive apatinib single or combined capecitabine for treatment of patients with metastatic her-2 negative breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| apatinib | Experimental | apatinib 500mg qd po or combined Capecitabine 1000mg/m2 bid d1-d14 q3w |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apatinib | Drug | apatinib 500mg qd po or combined capecitabine 1000mg/m2 bid d1-14 q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Baseline to measured date of progression or death from any cause | evaluated in 24 months since the treatment began |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Baseline to measured date of death from any cause | the first day of treatment to death or last survival confirm date,up to 24 months |
| Disease control rate | Baseline to measured progressive disease |
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Inclusion Criteria:
18 to 70 years old (female)
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Pathologically diagnosed with her-2 negative, ER/PR negative, ER/PR positive after the failure of endocrine treatment, and had not more than three chemotherapy regimens (must include anthracycline-based and yew class), and the final failure of chemotherapy regimens in patients with advanced breast cancer; Note: treatment failure include (1) during or after the completion of six months or less disease progress of neoadjuvant or adjuvant therapy; (2) rescue treatment in progress within 3 months or less
Patients with at least one measurable lesions of the advanced breast cancer, measurable lesions has not received radiotherapy or other treatment, unless progress after treatment (measuring≥10mm on spiral CT scan, satisfying the criteria in RECIST1.1 and WHO);
Major organ function has to meet the following certeria:
For results of blood routine test (without blood transfusion within 14 days)
For results of blood biochemical test:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| cuizhi Geng, archiat | Contact | 0311-66696310 | gengcuizhi@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| cuizhi Geng, archiat | Hebei Medical University Fourth Hospital | Principal Investigator |
| zefei Jiang, archiat | The 307th Hospital of Chinese Peoples' Liberation Army | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050019 | China |
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| tumor assessment every 6 weeks since the treatment began,up to 24 months |
| Objective response rate | Baseline to measured stable disease | tumor assessment every 6 weeks since the treatment began,up to 24 months |
| Side effects | throughout study | evaluated in the 24th month since the treatment began according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 |
| ID | Term |
|---|---|
| C553458 | apatinib |
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