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| Name | Class |
|---|---|
| Jiangsu HengRui Medicine Co., Ltd. | INDUSTRY |
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The hypothesis of this clinical research study is to discover if the study drug Famitinib Malate can shrink or slow the growth of pretreated HER2-negative metastatic breast cancer.
Famitinib Malate is a tyrosine kinase inhibitor mainly targeting vascular endothelial growth factor receptor 2(VEGFR2), and its anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the recommended phase II dose is 25 mg. The hypothesis of this clinical research study is to discover if the study drug Famitinib Malate can shrink or slow the growth of pretreated HER2-negative breast cancer. The safety of Famitinib Malate will also be studied. Patients physical state, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if Famitinib Malate is safe and effective in pretreated HER2-negative metastatic breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Famitinib Malate | Experimental | Famitinib 25mg/d |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib Malate | Drug | The starting dose of Famitinib Malate will be 25 mg/d. Two dose reductions will be allowed to 20 and then 15 mg/d. |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective response rate) | 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| PFS(Progression free survival) | 8 Weeks | |
| OS (Overall survival) | 8 Weeks | |
| CBR(Clinical benefit rate) |
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Inclusion Criteria:
●≥ 18 and ≤ 70 years of age.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xi-Chun Hu, Doctor | Fudan Univeristy Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24939214 | Derived | Cao J, Zhang J, Wang Z, Wang B, Lv F, Wang L, Hu X. Hypothyroidism as a potential biomarker of efficacy of famitinib, a novel VEGFR-2 inhibitor in metastatic breast cancer. Cancer Chemother Pharmacol. 2014 Aug;74(2):389-98. doi: 10.1007/s00280-014-2505-x. Epub 2014 Jun 18. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 8 Weeks |
| QoL (Quality of life) | 8 Weeks |
| Number of adverse events | 8 Weeks |
| D017437 |
| Skin and Connective Tissue Diseases |