'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
- Compare the 5-year and 10-year disease-free survival and overall survival of women with
completely resected early stage breast cancer treated with adjuvant paclitaxel,
epirubicin, and cyclophosphamide with or without gemcitabine.
- Compare the toxicity, dose-intensity, and tolerability of these regimens in these
- Compare the serious adverse events in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal
status (negative vs 1-3 vs 4 or more), age (50 and under vs over 50), estrogen receptor
status (negative vs weakly positive vs positive), concurrent radiotherapy (no vs yes), HER2
status (3+ overexpression vs other vs not measured), and country. Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3
hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8.
Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or
- Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I.
Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then
annually for 6 years.
PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for
this study within 3-4 years.
Allocation: Randomized, Primary Purpose: Treatment
Helen Howard, PhD
Cancer Research Campaign Clinical Trials Centre
United States: Federal Government