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

Breast Neoplasms Clinical Trial

Official title: Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers

Status Completed

Clinical Trial 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.

Clinical Trial Description

This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), multi-center (when more than 1 hospital or medical school team work on a medical research study) study evaluating the effectiveness and safety of trabectedin in 3 subpopulations of breast cancer participants: Group A: triple negative profile for estrogen receptor, progesterone receptor and human estrogen receptor, Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+) and Group C: familial breast cancer gene 1 (BRCA1) or breast cancer gene 2 (BRCA2) mutation carrier. Participants will receive trabectedin 1.3 milligram per square meter (mg/m^2) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over 3-hour every 3 weeks, on Day 1 of each cycle. Each cycle length will be 3 weeks. Treatment will be continued until disease progression, unmanageable toxicity, participant refusal or treatment delay no longer than 3 weeks due to toxicity. Efficacy will be primarily evaluated by percentage of participants with confirmed objective response by independent external review and Investigators assessment. Participants' safety will be monitored throughout the study. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT00580112
• Study type: Interventional
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Status: Completed
• Phase: Phase 2
• Start date: June 2007
• Completion date: August 2011