drugset
drugset / Trial / NCT00091442

A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer

NCT00091442 ↗

Phase 3 Completed 751 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.

Timeline

Start
2004-09
Primary completion
2008-12
Completion
2008-12

Outcome

Met primary endpoint

registry analysis (superiority or other test); Docetaxel vs DOXIL+Docetaxel; p <0.0001; Hazard Ratio (HR) 0.65 (95% CI 0.55 to 0.77); Log Rank NCT00091442 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 60 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 30 mg/m2 Intravenous

Indications

breast cancer