NCT00193180

Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

Detailed description

All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Imatinib	Imatinib
DRUG	Docetaxel	Docetaxel

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-05-01
• Completion: 2009-01-01
• First posted: 2005-09-19
• Last updated: 2016-05-27
• Results posted: 2013-05-14

Locations

6 sites across 1 country: United States