An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

Phase 2 Completed 127 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PharmaMar · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effectiveness and safety of trabectedin in 3 subpopulations of participants with previously treated progressive metastatic ( spread of a cancer from one organ or part to another non-adjacent organ or part) breast cancer (abnormal tissue that grows and spreads in the body until it kills) participants.

Timeline

Start: 2007-06
Primary completion: 2011-08
Completion: 2011-08

Publications

Delaloge S, Wolp-Diniz R, Byrski T, Blum JL, Goncalves A, Campone M, Lardelli P, Kahatt C, Nieto A, Cullell-Young M, Lubinski J. Activity of trabectedin in germline BRCA1/2-mutated metastatic breast cancer: results of an international first-in-class phase II study. Ann Oncol. 2014 Jun;25(6):1152-8. doi: 10.1093/annonc/mdu134. Epub 2014 Apr 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trabectedin	Small molecule	1.3 mg/m2	Intravenous
Background	Dexamethasone	Small molecule	4 mg	Oral
Background	Dexamethasone	Small molecule	20 mg	Oral

An Efficacy Study of Trabectedin in the Treatment of Participants With Specific Subtypes of Metastatic Breast Cancer

Summary

Timeline

Publications

Drugs

Indications