Viewing Study NCT00431795



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Last Modification Date: 2024-10-26 @ 9:30 AM
Study NCT ID: NCT00431795
Status: TERMINATED
Last Update Posted: 2013-02-13
First Post: 2007-02-05

Brief Title: Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer
Sponsor: Hellenic Oncology Research Group
Organization: Hellenic Oncology Research Group

Study Overview

Official Title: 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
Status Verified Date: 2013-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Due to poor accrual
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None