Adenocarcinoma
Conditions
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.
Interventions
DRUGEpirubicin 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
DRUGEpirubicin with a Taxane
Epirubicin = 75 mg/m2 per cycle Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease free survival at 3 years | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Assess safety in both treatment arms at 3 years | 3 years |
| Compare overall survival between the 2 treatment arms at 3 years | 3 years |
Countries
United States
Outcome results
None listed