drugset / Trial / NCT00593697

The Synergism Or Long Duration (SOLD) Study

NCT00593697

Phase 3 Completed 2168 enrolled Finnish Breast Cancer Group
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to compare disease-free survival (DFS) of women treated with concomitant trastuzumab plus docetaxel followed by FEC to that of the women treated with the same regimen followed by single-agent trastuzumab to complete one year of trastuzumab administration as adjuvant treatments of early HER2-positive breast cancer.

Timeline

Start
2008-01
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule 80 mg/m2
Comparator Docetaxel Small molecule 100 mg/m2
Comparator Trastuzumab Monoclonal antibody
Comparator Cyclophosphamide Other / unclassified
Comparator Epirubicin Small molecule
Comparator fluorouracil Small molecule

Indications