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Sponsors and Collaborators: |
Sanofi-Aventis Cancer International Research Group |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00312208 |
Primary objective :
Secondary objectives :
Condition | Intervention | Phase |
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Breast Cancer |
Drug: docetaxel, doxorubicin, cyclophosphamide Drug: Docetaxel,doxorubicin, cyclophosphamide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter Phase III Randomized Trial Comparing Docetaxel in Combination With Doxorubicin and Cyclophosphamide Versus Doxorubicin and Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment of Operable Breast Cancer HER2neu Negative Patients With Positive Axillary Lymph Nodes |
Enrollment: | 3298 |
Study Start Date: | August 2000 |
Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: docetaxel, doxorubicin, cyclophosphamide
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
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2: Experimental |
Drug: Docetaxel,doxorubicin, cyclophosphamide
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
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Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
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 neoplasm other than breast carcinoma, except for:
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 ( Medical Affairs Study Director ) |
Study ID Numbers: | TAX_GMA_301, BCIRG 005 |
Study First Received: | April 5, 2006 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00312208 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Skin Diseases Immunologic Factors Adjuvants, Immunologic Breast Neoplasms Cyclophosphamide Immunosuppressive Agents Doxorubicin |
Docetaxel Anti-Bacterial Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |