Vinorelbine Versus Gemcitabine Plus Vinorelbine in Metastatic Breast Cancer Patients

Summary

This is a multicenter, randomized, prospective, Phase III study in which patients with advanced breast carcinoma previously treated with anthracyclines and taxanes will be randomly assigned to receive one of two treatment options: vinorelbine (Arm A) or gemcitabine plus vinorelbine (Arm B).

Timeline

Start

2001-01-18

Primary completion

2006-08-15

Completion

2008-01-24

Outcome

Met primary endpoint

paper Median progression-free survival was 6.0 months (95% CI 4.8-7.1) for patients given gemcitabine plus vinorelbine and 4.0 months (2.9-5.1) for those assigned vinorelbine PMID 17329192 ↗

paper there was 1.9 months of difference (hazard ratio 0.66 [0.50-0.88]; p=0.0028). PMID 17329192 ↗

Publications

• Martin M, Ruiz A, Munoz M, Balil A, Garcia-Mata J, Calvo L, Carrasco E, Mahillo E, Casado A, Garcia-Saenz JA, Escudero MJ, Guillem V, Jara C, Ribelles N, Salas F, Soto C, Morales-Vasquez F, Rodriguez CA, Adrover E, Mel JR; Spanish Breast Cancer Research Group (GEICAM) trial. Gemcitabine plus vinorelbine versus vinorelbine monotherapy in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: final results of the phase III Spanish Breast Cancer Research Group (GEICAM) trial. Lancet Oncol. 2007 Mar;8(3):219-25. doi: 10.1016/S1470-2045(07)70041-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gemcitabine	Small molecule	1200 mg/m2	Intravenous
Subject	Vinorelbine	Small molecule	30 mg/m2	Intravenous

Indications