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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT 2006-006473-24 |
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The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A1 | Experimental | Cohort 1: Her2-ve breast cancer |
|
| Arm B1 | Active Comparator | Cohort 1: Her2-ve breast cancer |
|
| Arm A2 | Experimental | Cohort 2: Her2+ve breast cancer |
|
| Arm B2 | Active Comparator | Cohort 2: Her2+ve breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| larotaxel (XRP9881) | Drug | intravenous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological response will be assessed according to Chevallier criteria for patients who underwent surgery. | treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate, Rate of breast conservation, Progression-Free Survival, Overall Survival, pathological response according to NSABP and Sataloff criteria for patients who underwent surgery | treatment period | |
| Safety and tolerability profile | treatment period |
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Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Michel Marty, MD | Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Diegem | Belgium | ||||
| Sanofi-Aventis Administrative Office |
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| docetaxel |
| Drug |
intravenous administration |
|
| trastuzumab | Drug | intravenous administration |
|
| São Paulo |
| Brazil |
| Sanofi-Aventis Administrative Office | Paris | France |
| Sanofi-Aventis Administrative Office | Berlin | Germany |
| Sanofi-Aventis Administrative Office | Warsaw | Poland |
| Sanofi-Aventis Administrative Office | Mégrine | Tunisia |
| Sanofi-Aventis Administrative Office | Guildford | United Kingdom |
| Sanofi-Aventis Administrative Office | Montevideo | Uruguay |
| 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 |
| D000077143 | Docetaxel |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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