Maintenance Treatment With Liposomal Doxorubicin (Caelyx) in Metastatic Breast Cancer Patients

Phase 4 Completed 288 enrolled Spanish Breast Cancer Research Group Schering-Plough · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, prospective and multicenter phase IV clinical trial, which has been designed as a phase III study. One hundred fifty-four women (77 per treatment arm) will be recruited in the study.

Timeline

Start: 2002-10-28
Primary completion: 2007-06-01
Completion: 2010-07-07

Outcome

Met primary endpoint

paper PLD significantly improved TTP by 3.3 months (8.4 vs. 5.1 months; hazard ratio [HR] = 0.54, 95% CI: 0.39 to 0.76, P = 0.0002) PMID 20361253 ↗

Publications

Results Alba E, Ruiz-Borrego M, Margeli M, Rodriguez-Lescure A, Sanchez-Rovira P, Ruiz A, Mel-Lorenzo JR, Ramos-Vazquez M, Ribelles N, Calvo E, Casado A, Marquez A, Vicente D, Garcia-Saenz JA, Martin M. Maintenance treatment with pegylated liposomal doxorubicin versus observation following induction chemotherapy for metastatic breast cancer: GEICAM 2001-01 study. Breast Cancer Res Treat. 2010 Jul;122(1):169-76. doi: 10.1007/s10549-010-0860-9. Epub 2010 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Doxorubicin	Other / unclassified	40 mg/m2	—