drugset

drugset / Trial / NCT00050427

A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer

NCT00050427 ↗

Phase 2 Completed 53 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.

Timeline

Start: 2002-12
Primary completion: —
Completion: 2006-12

Publications

Goldstein LJ, Gurtler J, Del Prete SA, Tjulandin S, Semiglazov VF, Bayever E, Michiels B. Trabectedin as a single-agent treatment of advanced breast cancer after anthracycline and taxane treatment: a multicenter, randomized, phase II study comparing 2 administration regimens. Clin Breast Cancer. 2014 Dec;14(6):396-404. doi: 10.1016/j.clbc.2014.06.006. Epub 2014 Aug 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trabectedin	Small molecule	0.58 mg/m2	Intravenous
Subject	Trabectedin	Small molecule	1.3 mg/m2	Intravenous

Indications