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: Cyclophosphamide+Methotrexate+Fluorouracil (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 |
Enrollment: | 998 |
Study Start Date: | December 1997 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
Sequential Epidoxorubicin followed by CMF: ciclophosphamide/Methotrexate/fluorouracile (±TAM: tamoxifen)
|
Drug: epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile
Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM)
|
B: Experimental
Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
|
Drug: epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile
Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM)
|
C: Experimental
Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
|
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:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
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: | July 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00174707 History of Changes |
Health Authority: | Italy: The Italian Medicines Agency |
Antimetabolites Skin Diseases Immunologic Factors Folate Breast Neoplasms Cyclophosphamide Folinic Acid Folic Acid Antagonists Epirubicin Immunosuppressive Agents |
Vitamin B9 Folic Acid Docetaxel Anti-Bacterial Agents Fluorouracil Methotrexate Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Reproductive Control Agents Antibiotics, Antineoplastic Docetaxel Neoplasms by Site Therapeutic Uses Abortifacient Agents Methotrexate Dermatologic Agents |
Alkylating Agents Nucleic Acid Synthesis Inhibitors Breast Diseases Skin Diseases Breast Neoplasms Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Epirubicin Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |