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Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genexol®-PM | Experimental | This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). |
|
| Genexol® | Active Comparator | This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genexol-PM® | Drug | Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response | To evaluate the efficacy of Genexol®-PM relative to Genexol® as measured by Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response. | Event driven |
| Safety and toxicity |
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Inclusion Criteria:
Subjects should meet all of the following criteria to participate in the trial.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si, Gyeonggi-do | 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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| Genexol® |
| Drug |
Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks |
|
To compare the safety and toxicity of Genexol®-PM with those of Genexol® |
| Throughout study |
| D017437 |
| Skin and Connective Tissue Diseases |