NCT00199212

PS-341 in Combination With Herceptin in Advanced Breast Cancer That Overexpresses HER-2

A Phase I, Open Label, Dose-escalating Study of the Proteasome Inhibitor PS-341 in Combination With Two Schedules of Herceptin, in Patients With Advanced Breast Cancer That Overexpresses HER-2

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Jules Bordet Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) and to determine the best dose of bortezomib to combine with two trastuzumab schedules, weekly and 3-weekly.

Detailed description

Phase 1 study to determine the feasibility of the combination of the proteasome inhibitor bortezomib (PS-341, Velcade) with trastuzumab (Herceptin) given either weekly or 3-weekly. Additionally, hints about efficacy of the combination will be looked upon.

Conditions

• Carcinoma Breast Stage IV

Interventions

Type	Name	Description
DRUG	Combination of trastuzumab and PS-341	Trastuzumab and velcade are used according standard procedure

Timeline

• Start date: 2003-10-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2005-09-20
• Last updated: 2011-02-24

Locations

1 site across 1 country: Belgium