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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174655 |
Primary objectives:
Secondary objectives:
Condition | Intervention | Phase |
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Breast Neoplasms |
Drug: Doxorubicine + docetaxel sequential Drug: doxorubicine + cyclophosphamide sequential Drug: doxorubicine + cyclophosphamide combined Drug: doxorubicine + docetaxel combined |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvant Treatment of Node-Positive Breast Cancer Patients. |
Enrollment: | 2887 |
Study Start Date: | June 1998 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Active Comparator |
Drug: doxorubicine + cyclophosphamide sequential
doxorubicin 75 mg/m² i.v. day 1 q 21 days for 4 cycles, followed by CMF (C: cyclophosphamide 100 mg/m² orally days 1-14, M: methotrexate: 40 mg/m² i.v. days 1 and 8, FU; 5-fluorouracil: 600 mg/m²) i.v. days 1 and 8, q 28 days for 3 cycles
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A2: Active Comparator |
Drug: doxorubicine + cyclophosphamide combined
doxorubicin 60 mg/m² i.v. + cyclophosphamide 600 mg/m² i.v., day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
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B: Experimental |
Drug: Doxorubicine + docetaxel sequential
doxorubicin 75 mg/m² i.v. day 1, q 21 days for 3 cycles, followed by docetaxel 100 mg/m² i.v., 1 hour infusion, day 1, q 21 days for 3 cycles, followed by CMF for 3 cycles
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C: Experimental |
Drug: doxorubicine + docetaxel combined
doxorubicin 50 mg/m² i.v. + docetaxel 75 mg/m² i.v. 1 hour infusion (1 hour after doxorubicin), day 1, q 21 days for 4 cycles, followed by CMF for 3 cycles.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory requirements: (within 14 days prior to registration)
Hematology
Hepatic function
Renal function
Exclusion Criteria:
Other serious illness or medical condition:
Past or current history of other neoplasms except for:
In regard to past or current history of other breast carcinoma, criteria of exclusion are:
A past or current history of ipsilateral ductal in situ or lobular in situ (ipsilateral or contralateral) breast carcinoma is not a criterion of exclusion.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study Director: | Jean-Philippe Aussel | Sanofi-Aventis |
Responsible Party: | sanofi-aventis groupe ( Medical Affairs Study Director ) |
Study ID Numbers: | RP56976_PR_315 |
Study First Received: | September 9, 2005 |
Last Updated: | December 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00174655 |
Health Authority: | Belgium: Directorate general for the protection of Public health: Medicines |
Docetaxel Skin Diseases Fluorouracil Methotrexate |
Breast Neoplasms Cyclophosphamide Doxorubicin 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 |