NCT00431795

Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy

Detailed description

To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Pegylated liposomal doxorubicin (Caelyx)	Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m\^2 IV every 4 weeks for 6 consecutive cycles
DRUG	Epirubicin	Epirubicin (Farmorubicin) at the dose of 90mg/m\^2 IV every 3 weeks for 6 consecutive cycles

Timeline

• Start date: 2003-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2007-02-06
• Last updated: 2013-02-13

Locations

10 sites across 1 country: Greece