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The purpose of this study is to evaluate the response rate in patients with taxane-pretreated recurrent breast cancer receiving paclitaxel loaded polymeric micelle (Genexol-PM).
Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase IV study was designed to evaluate the response rate, toxicity, progression free survival and tumor control rate of Genexol-PM in patients with Taxane-pretreated recurrence breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genexol-PM | Experimental | All the patients are recurrent breast cancer after taxane treatment. Patients with a measurable lesion (at least 1 measurable lesion)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel loaded Polymeric micelle | Drug | Genexol-PM at a dose of 300mg/m2 was diluted in 500 ml of 5% dextrose solution or normal saline and infused i.v. for 3 h on day 1.Treatment was repeated every 3 weeks until either disease progression or intolerance. A minimum of 6 cycles was recommended. |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate was assessed by imaging using the RECIST (Response Evaluation Criteria In Solid Tumor) guideline | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity | 1 year | |
| Progression Free Survival | 1 year | |
| Tumor control rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-Joo Song, MD.PhD. | The Catholoic university of Korea, St. Mary's hospital. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of surgery, The Catholoic university of Korea, St. Mary's hospital. | Seoul | South Korea |
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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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| ID | Term |
|---|---|
| C000708971 | genexol-PM |
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| 1 year |
| D017437 |
| Skin and Connective Tissue Diseases |