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Sponsors and Collaborators: |
Jules Bordet Institute Institut Gustave Roussy Centre Paul Strauss Centre Hospitalier de Luxembourg - Luxembourg Clinique Louis Cathy - Baudour - Belgium HIS - Site Etterbeek - Ixelles - Belgium Clinique Saint Pierre - Ottignies -Belgium Clinique Ste Elisabeth - Namur - Belgium University Hospital of Crete Feculdade de Medicina da Universidade de Sao Paulo - Brasil |
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Information provided by: | Jules Bordet Institute |
ClinicalTrials.gov Identifier: | NCT00162812 |
prospective evaluation of topoisomerase II alpha gene amplification and protein overexpression as markers predicting the efficacy of epirubicin in the primary treatment of breast cancer patients.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Epirubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Prospective Evaluation of Topoisomerase II Alpha Gene Amplification and Protein Overexpression as Markers Predicting the Efficacy of Epirubicin in the Primary Treatment of Breast Cancer Patients |
Estimated Enrollment: | 338 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Serious medical conditions like:
Belgium | |
Jules Bordet Institute | |
Brussels, Belgium, 1000 |
Principal Investigator: | Veronique D'Hondt, MD, PhD | Jules Bordet Institute |
Study Chair: | Martine Piccart, MD, PhD | Jules Bordet Institute |
Responsible Party: | Jules Bordet Institute ( Veronique D'Hondt ) |
Study ID Numbers: | TOP Trial, CE1141 |
Study First Received: | September 9, 2005 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00162812 History of Changes |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
neoadjuvant chemotherapy early breast cancer inflammatory breast cancer |
Anti-Bacterial Agents Inflammatory Breast Cancer Skin Diseases |
Breast Neoplasms Epirubicin Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Antineoplastic Agents Therapeutic Uses |
Breast Neoplasms Antibiotics, Antineoplastic Epirubicin Pharmacologic Actions Breast Diseases |