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| ID | Type | Description | Link |
|---|---|---|---|
| XRP9881B/2001 | |||
| EUDRACT : 2004-000572-14 |
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The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.
All patients in this trial will receive the investigational (chemotherapy) drug at an optimal dose as determined by previous clinical trials. The investigational drug is given through a vein once every three weeks. This drug prevents tumor cells from dividing, so they may stop growing or die.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XRP9881 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks | ||
| Time to tumor response and duration of response. | ||
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Inclusion Criteria:
In order to be eligible for this trial you must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ICD CSD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
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| Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs. |
| Buenos Aires |
| Argentina |
| Sanofi-Aventis Administrative Office | Diegem | Belgium |
| Sanofi-Aventis Administrative Office | Laval | Canada |
| Sanofi-Aventis Administrative Office | Bogotá | Colombia |
| Sanofi-Aventis Administrative Office | Hørsholm | Denmark |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Milan | Italy |
| Sanofi-Aventis Administrative Office | Gouda | Netherlands |
| Sanofi-Aventis Administrative Office | Midrand | South Africa |
| Sanofi-Aventis Administrative Office | Seoul | South Korea |
| Sanofi-Aventis Administrative Office | Barcelona | Spain |
| Sanofi-Aventis Administrative Office | Geneva | Switzerland |
| Sanofi-Aventis Administrative Office | Istanbul | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C531079 | larotaxel |
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