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Sponsored by: |
Central European Cooperative Oncology Group |
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Information provided by: | Central European Cooperative Oncology Group |
ClinicalTrials.gov Identifier: | NCT00286819 |
This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Cancer |
Drug: Fluorouracil, Epirubicin, Cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Phase II Study of Dose-Dense Fluorouracil Plus Epirubicin 75 Plus Cyclophosphamide (FEC75) and Fluorouracil Plus Epirubicin 90 Plus Cyclophosphamide (FEC90) as Adjuvant Therapy for Early Breast Cancer |
Enrollment: | 50 |
Study Start Date: | April 2005 |
Study Completion Date: | September 2006 |
Arm A: the FEC75 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Arm B: the FEC90 regimen will be given at the following doses:
Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.
All three drugs will be administered intravenously on Day 1 of each 14-day cycles.
Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.
Six cycles of adjuvant chemotherapy will be administered in both arms (A + B)
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
AKH, Universitätsklinik für Innere Medizin 1 | |
Vienna, Austria, 1090 | |
Hungary | |
Onkotherápiás Klinika, | |
Szeged, Hungary | |
Poland | |
Medical University of Gdansk, Dept. of Oncology and Radiotherapy | |
Gdansk, Poland, 80-211 | |
Slovakia | |
Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav | |
Bratislava, Slovakia, 81250 | |
Oncology Institute, Department of Radiotherapy and Onclogy | |
Kosice, Slovakia, 04191 |
Principal Investigator: | Thomas Brodowicz, Prof | Univ. Klinik für innere Medizin I |
Study ID Numbers: | CECOG/Breast.2.2.005 |
Study First Received: | February 3, 2006 |
Last Updated: | May 10, 2007 |
ClinicalTrials.gov Identifier: | NCT00286819 |
Health Authority: | Austria: Federal Ministry for Health and Women |
early breast cancer, Fluorouracil |
Skin Diseases Fluorouracil Breast Neoplasms |
Cyclophosphamide Epirubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |