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Sponsors and Collaborators: |
Centre Jean Perrin Merck Sanofi-Aventis |
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Information provided by: | Centre Jean Perrin |
ClinicalTrials.gov Identifier: | NCT00600249 |
The purpose of this study is to assess the pathological response rate in operable breast cancer patients treated by neoadjuvant combination "Taxotere-Erbitux".
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Cetuximab Drug: Docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Pilot Study Evaluating the Neoadjuvant Combination "Taxotere (Docetaxel) and Erbitux (Cetuximab) in Operable and "Triple Negative" Breast Cancer Patients. TENEO Study. |
Estimated Enrollment: | 35 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France | |
Centre Jean Perrin | |
Clermont-Ferrand, France, 63011 | |
Centre Hospitalier de la Dracénie | |
Draguignan, France, 83007 | |
Centre Léon Berard | |
Lyon, France, 69373 | |
Hopital Nord La Tronche | |
Grenoble, France, 38043 | |
CHD La Roche-sur-Yon | |
La Roche-sur-Yon, France, 85925 |
Responsible Party: | Centre Jean Perrin ( Philippe Chollet ) |
Study ID Numbers: | TENEO |
Study First Received: | January 14, 2008 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00600249 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: Afssaps - French Health Products Safety Agency |
Breast cancer. Triple negative. Neoadjuvant chemotherapy. Targeted therapy. |
Docetaxel Skin Diseases Cetuximab Breast Neoplasms Breast Diseases |
Docetaxel Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents |
Therapeutic Uses Cetuximab Breast Neoplasms Pharmacologic Actions Breast Diseases |