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Difficulty accruing subjects the study accrual was closed.
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The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression.
This is a phase II, single center, prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that deferoxamine can increase anti-tumor effect. The objective of the study is to evaluate the efficacy and safety of chemotherapy plus deferoxamine in metastatic breast cancer whose evaluation is stable disease with a trend of progression after second-line. This study plans to recruit 30 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental | Deferoxamine:50mg/kg+500ml normal saline (NS) plus chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferoxamine Plus Chemotherapy | Drug | Deferoxamine:50mg/kg+500ml normal saline (NS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| clinical benefit rate (CBR) | the proportion of patients with tumors complete response, partial response, and stable disease | 6 months |
| progression-free survival (PFS) | the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhong-yu Yuan, M.D. | Sun Yat-sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | 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 |
|---|---|
| D003676 | Deferoxamine |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| 6 months |
| overal survival (OS) | the time from the beginning of treatment for metastatic breast cancer to death from any cause | 12 months |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006880 |
| Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D013812 | Therapeutics |