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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00485979 |
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:
Condition | Intervention | Phase |
---|---|---|
Breast Neoplasms |
Drug: larotaxel (XRP9881) Drug: docetaxel Drug: trastuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Open-Label, Multi-Center Study of Larotaxel at 90mg/m2 or Docetaxel Every 3 Weeks, Alone or in Combination With Trastuzumab According to Her2neu Status, Administered After a Combination of Anthracycline and Cyclophosphamide as Pre-Operative Therapy in Patients With High Risk Localized Breast Cancer. |
Estimated Enrollment: | 310 |
Study Start Date: | June 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm A1: Experimental
Cohort 1: Her2-ve breast cancer
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Drug: larotaxel (XRP9881)
intravenous administration
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Arm B1: Active Comparator
Cohort 1: Her2-ve breast cancer
|
Drug: docetaxel
intravenous administration
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Arm A2: Experimental
Cohort 2: Her2+ve breast cancer
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Drug: larotaxel (XRP9881)
intravenous administration
Drug: trastuzumab
intravenous administration
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Arm B2: Active Comparator
Cohort 2: Her2+ve breast cancer
|
Drug: docetaxel
intravenous administration
Drug: trastuzumab
intravenous administration
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.
Belgium | |
Sanofi-Aventis Administrative Office | |
Diegem, Belgium | |
Brazil | |
Sanofi-Aventis Administrative Office | |
Sao Paulo, Brazil | |
France | |
Sanofi-Aventis Administrative Office | |
Paris, France | |
Germany | |
Sanofi-Aventis Administrative Office | |
Berlin, Germany | |
Poland | |
Sanofi-Aventis Administrative Office | |
Warszawa, Poland | |
Tunisia | |
Sanofi-Aventis Administrative Office | |
Megrine, Tunisia | |
United Kingdom | |
Sanofi-Aventis Administrative Office | |
Guildford, United Kingdom | |
Uruguay | |
Sanofi-Aventis Administrative Office | |
Montevideo, Uruguay |
Principal Investigator: | Michel Marty, MD | Centre for Therapeutic Innovations in Oncology and Haematology / Saint Louis University Hospital |
Responsible Party: | sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC10073, EudraCT 2006-006473-24 |
Study First Received: | June 12, 2007 |
Last Updated: | January 29, 2009 |
ClinicalTrials.gov Identifier: | NCT00485979 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Breast Cancer Neoadjuvant therapy |
Docetaxel Immunologic Factors Skin Diseases Trastuzumab Breast Neoplasms Antineoplastic Agents, Alkylating |
Cyclophosphamide Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions Docetaxel |
Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Trastuzumab Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |