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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00140075 |
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.
Condition | Intervention | Phase |
---|---|---|
Adenocarcinoma |
Drug: Epirubicin with Cyclophosphamide, followed by a Taxane Drug: Epirubicin with a Taxane |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer |
Enrollment: | 603 |
Study Start Date: | November 2000 |
Estimated Study Completion Date: | December 2008 |
Arms | Assigned Interventions |
---|---|
B: Experimental
ET (8 cycles) T = docetaxel or paclitaxel |
Drug: Epirubicin with a Taxane
Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
A: Experimental
EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel |
Drug: Epirubicin with Cyclophosphamide, followed by a Taxane
Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2 Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | 378-ONC-0030-184 |
Study First Received: | August 29, 2005 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00140075 |
Health Authority: | United States: Food and Drug Administration |
Docetaxel Skin Diseases Paclitaxel Breast Neoplasms Cyclophosphamide Adenocarcinoma |
Taxane Epirubicin Breast Diseases Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms by Histologic Type 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 |