NCT00465673

Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Primary objective: To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis Secondary objectives: 1. To determine the overall objective response rate (ORR) 2. To determine the progression free survival, and duration of objective response 3. To evaluate the overall survival (OS) 4. To assess the safety profiles

Detailed description

This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design. Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal. Recruitment period: 10 months

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Doxorubicin	40mg/m2 over 1 hour infusion for 21 days

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2007-04-25
• Last updated: 2009-08-06

Locations

1 site across 1 country: Singapore