Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer

Completed 80 enrolled European Organisation for Research and Treatment of Cancer - EORTC

RandomizedTreatment

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.

Timeline

Start: 1998-12
Primary completion: 2004-11
Completion: —

Outcome

Missed primary endpoint

paper The least toxic time of G3-4 neutropenia was observed at 21:00 h with a non-significant 90% CI. PMID 18780198 ↗

Publications

Results Coudert B, Focan C, Genet D, Giacchetti S, Cvickovic F, Zambelli A, Fillet G, Chollet P, Amoroso D, Van Der Auwera J, Lentz MA, Marreaud S, Baron B, Gorlia T, Biville F, Levi F. A randomized multicenter study of optimal circadian time of vinorelbine combined with chronomodulated 5-fluorouracil in pretreated metastatic breast cancer patients: EORTC trial 05971. Chronobiol Int. 2008 Sep;25(5):680-96. doi: 10.1080/07420520802384036.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vinorelbine	Small molecule	25 mg/m2	Intravenous
Subject	Vinorelbine	Small molecule	30 mg/m2	Intravenous
Subject	fluorouracil	Small molecule	850 mg/m2	Intravenous