NCT00140075

Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Pfizer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Adenocarcinoma

Interventions

Type	Name	Description
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
DRUG	Epirubicin with a Taxane	Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

Timeline

• Start date: 2000-11-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2005-08-31
• Last updated: 2011-05-26

Locations

54 sites across 1 country: United States