Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sanofi-Aventis |
---|---|
Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00174707 |
Primary objectives:
Secondary objectives:
Condition | Intervention | Phase |
---|---|---|
Breast Neoplasms |
Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile Drug: epidoxorubicine, docetaxel, cyclophosphamide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase III Randomized Study of Sequential Epidoxorubicin Followed By CMF (Arm A) Versus Sequential Epidoxorubicin Followed By Docetaxel Followed By CMF (Arm B) Versus Sequential Intensified Epidoxorubicin Followed By Docetaxel Followed By High-Dose Cyclophosphamide (Arm C) in Early Breast Cancer Patients With Positive Axillary Lymph Nodes |
Estimated Enrollment: | 914 |
Study Start Date: | July 1998 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator |
Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile
Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)
|
B: Experimental |
Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile
Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
|
C: Experimental |
Drug: epidoxorubicine, docetaxel, cyclophosphamide
Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Laboratory requirements:
Hematology :
Hepatic function:
Renal function :
Exclusion criteria:
Other serious illnesses or medical conditions:
Responsible Party: | Sanofi-aventis aministrative office ( Medical Affairs Medical Director ) |
Study ID Numbers: | TAX_IT1_302, TAX_IT_216 |
Study First Received: | September 12, 2005 |
Last Updated: | April 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00174707 |
Health Authority: | Italy: The Italian Medicines Agency |
Folic Acid Docetaxel Skin Diseases Methotrexate |
Breast Neoplasms Cyclophosphamide Epirubicin Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Antibiotics, Antineoplastic Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Abortifacient Agents Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors |