Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Danish Breast Cancer Cooperative Group Fonden til fremme af klinisk eksperimentel cancerforskning vedrørende c. mammae Sanofi-Aventis Dako |
---|---|
Information provided by: | Danish Breast Cancer Cooperative Group |
ClinicalTrials.gov Identifier: | NCT00689156 |
The DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.
Condition | Intervention | Phase |
---|---|---|
Breast Neoplasms |
Drug: Epirubicin, cyclophosphamide and docetaxel Drug: docetaxel, cyclophosphamide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Trial of Epirubicin and Cyclophosphamide Followed by Docetaxel Against Docetaxel and Cyclophosphamide in Patients With TOP2A Normal Early Breast Cancer |
Estimated Enrollment: | 1932 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | January 2022 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Regimen 1: Active Comparator
Epirubicin 90 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times three followed by docetaxel 100 mg/m2 intravenously day 1 every 3 weeks times three
|
Drug: Epirubicin, cyclophosphamide and docetaxel
Epirubicin 90 mg/m2 iv day 1 every 3 weeks plus Cyclophosphamide 600 mg/m2 iv day 1 every 3 weeks times 3 followed by Docetaxel 100 mg/m2 iv day 1 every 3 weeks times 3
|
Regimen 2: Experimental
Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
|
Drug: docetaxel, cyclophosphamide
Docetaxel 75 mg/m2 plus cyclophosphamide 600 mg/m2 intravenously day 1 every 3 weeks times six
|
In DBCG trial 89D we in more than 1,200 patients showed that substitution in CMF chemotherapy of methotrexate with epirubicin improves survival for patients with primary and operable breast cancer. In a retrospective evaluation we have also shown that approximately 20% of all patients in 89D have tumors with numerical changes of the TOP2A gene, and that only patients with abnormal TOP2A benefit from epirubicin. In the current trial the DBCG wishes to clarify if recurrence-free and overall life expectancy is longer after docetaxel and cyclophosphamide compared to epirubicin and cyclophosphamide followed by docetaxel in patients with TOP2A normal and operable breast cancer.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Trial Population:
Inclusion Criteria:
Exclusion Criteria:
Contact: Bent Ejlertsen, M.D. | 45-3545-5088 | ejlertsen@rh.dk |
Contact: Henning T. Mouridsen, M.D. | 45-3445-4776 | mou@dbcg.dk |
Denmark | |
Dept. of Oncology; Rigshospitalet | Recruiting |
Copenhagen, Denmark, DK-2100 | |
Contact: Bent Ejlertsen, M.D. 45-3545-5088 ejlertsen@rh.dk | |
Dept. of Oncology; Herlev Hospital | Recruiting |
Herlev, Denmark, DK-2730 | |
Contact: Gosia Tuxen, M.D. GOSTUX01@heh.region.dk | |
Dept. of Oncology; Nordsjællands Hospital Hillerød | Recruiting |
Hillerød, Denmark, DK-3400 | |
Contact: Mogens Hansen, M.D. moha@noh.regionh.dk | |
Dept. of Oncology; Sygehus Øst Roskilde | Recruiting |
Roskilde, Denmark, DK-4000 | |
Contact: Peter G. Sørensen, M.D. rspgr@ra.dk | |
Dept. of Oncology; Sygehus Syd Næstved | Recruiting |
Næstved, Denmark, DK-4700 | |
Contact: Preben Philip, M.D. prebenphilip@newmail.dk | |
Dept. of internal medicine; Bornholms Hospital | Recruiting |
Rønne, Denmark, DK-3700 | |
Contact: Ditte Nielsen, M.D. ditte.nielsen@bcsygehus.dk | |
Dept. of Oncology; Aalborg Sygehus | Active, not recruiting |
Aalborg, Denmark, DK-9000 | |
Dept. of Oncology; Sydvestjysk Sygehus Esbjerg | Recruiting |
Esbjerg, Denmark, DK-6700 | |
Contact: Brita B. Jensen, M.D. bbje@ribeamt.dk | |
Dept. of Oncology; Vejle Sygehus | Recruiting |
Vejle, Denmark, DK-7100 | |
Contact: Erik H. Jakobsen, M.D. erik.hugger.jakobsen@vgs.regionsyddanmark.dk | |
Dept. of Oncology; Regionshospitalet Herning | Recruiting |
Herning, Denmark, DK-7400 | |
Contact: Knud A. Møller, M.D. heckam@ringamt.dk | |
Dept. of Oncology; Århus Sygehus | Recruiting |
Århus, Denmark, DK-8000 | |
Contact: Inger Højris, M.D. ihojr@as.aaa.dk | |
Dept. of Oncology; Regionshospitalet Viborg | Recruiting |
Viborg, Denmark, DK-8800 | |
Contact: Vera Haahr, M.D. vera.haahr@sygehusviborg.dk | |
Dept. of Oncology; Odense University Hospital | Recruiting |
Odense, Denmark, DK-5000 | |
Contact: Ann S. Knoop, M.D. knoop@dadlnet.dk |
Principal Investigator: | Bent Ejlertsen, M.D. | Rigshospitalet, Denmark |
Study Director: | Henning T. Mouridsen, M.D. | Rigshospitalet, Denmark |
Responsible Party: | Dept. of Oncology, Bldg. 4262 Rigshospitalet, Copenhagen ( Bent Ejlertsen, M.D., Ph.D. ) |
Study ID Numbers: | DBCG 07-READ |
Study First Received: | May 29, 2008 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00689156 |
Health Authority: | Denmark: Danish Medicines Agency; Denmark: Danish Dataprotection Agency; Denmark: The Danish National Committee on Biomedical Research Ethics |
Epirubicin docetaxel Adjuvant chemotherapy DNA Topoisomerases, Type II |
Docetaxel Skin Diseases Breast Neoplasms |
Cyclophosphamide Epirubicin Breast Diseases |
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 |