Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer
Phase 3
Completed
- Conditions
- Adenocarcinoma
- Interventions
- Registration Number
- NCT00140075
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 606
Inclusion Criteria
- Breast Cancer Stage T1-3, N1, M0
- Suitable candidate for anthracycline-containing adjuvant chemotherapy
Exclusion Criteria
- Evidence of residual tumor following surgery, or metastatic disease
- Received prior therapy for breast cancer
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B Epirubicin with a Taxane ET (8 cycles) T = docetaxel or paclitaxel A Epirubicin with Cyclophosphamide, followed by a Taxane EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel
- Primary Outcome Measures
Name Time Method Disease free survival at 3 years 3 years
- Secondary Outcome Measures
Name Time Method Assess safety in both treatment arms at 3 years 3 years Compare overall survival between the 2 treatment arms at 3 years 3 years
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Milwaukee, Wisconsin, United States