MedTrace Logo

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

NCT00431795 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-02-13

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Dimitris Mavrudis, MD · University Hospital of Crete

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00431795 on ClinicalTrials.gov