Docetaxel vs. Docetaxel-Gemcitabine in Breast Cancer

NCT00191243 ↗

Phase 2 Completed 237 enrolled Eli Lilly and Company

RandomizedParallel-groupOpen-labelTreatment

Summary

Randomized,non-blinded,multi-center study in patients with metastatic breast cancer.Patients will be treated with docetaxel or docetaxel-gemcitabine. Aim of the study is to assess the optimal dosage and safety in this setting.

Timeline

Start: 2002-03
Primary completion: 2007-08
Completion: 2009-04

Outcome

Missed primary endpoint

paper The median TTF was 5.6 and 6.2 months in groups D and D/G, respectively (hazard ratio 0.85, 95% confidence interval 0.63-1.16; P = 0.31). PMID 19819914 ↗

Publications

Results Joensuu H, Sailas L, Alanko T, Sunela K, Huuhtanen R, Utriainen M, Kokko R, Bono P, Wigren T, Pyrhonen S, Turpeenniemi-Hujanen T, Asola R, Leinonen M, Hahka-Kemppinen M, Kellokumpu-Lehtinen P. Docetaxel versus docetaxel alternating with gemcitabine as treatments of advanced breast cancer: final analysis of a randomised trial. Ann Oncol. 2010 May;21(5):968-73. doi: 10.1093/annonc/mdp397. Epub 2009 Oct 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	80 mg/m2	Intravenous
Subject	Gemcitabine	Small molecule	1000 mg/m2	Intravenous