Suspended

Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer

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What is being tested

Cyclophosphamide

+ Liposomal-encapsulated doxorubicin

Drug
Who is being recruted

Breast Diseases+12

+ Breast Neoplasms

+ Cardiovascular Diseases

Over 18 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: September 2009
See protocol details

Summary

Principal SponsorHellenic Oncology Research Group
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2009

Actual date on which the first participant was enrolled.

Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer

Official TitleLiposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer
NCT01120171
Principal SponsorHellenic Oncology Research Group
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

64 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsCardiovascular DiseasesHeart DiseasesNeoplasmsNeoplasms by SitePathologic ProcessesRadiation InjuriesSkin DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesSkin and Connective Tissue DiseasesChemically-Induced DisordersDrug-Related Side Effects and Adverse ReactionsCardiotoxicity

Criteria

12 inclusion criteria required to participate
Histologically or cytologically confirmed metastatic breast adenocarcinoma
No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.
Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)
Performance status (WHO) 0-2
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6 exclusion criteria prevent from participating
Active infection
History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period
Other invasive malignancy except non-melanoma skin cancer
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Cyclofosfamide/Liposomal-encapsulated doxorubicin

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Suspended

University General Hospital of Alexandroupolis

Alexandroupoli, GreeceOpen University General Hospital of Alexandroupolis in Google Maps
Suspended

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece
Suspended

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece
Suspended

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece
Suspended11 Study Centers
Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer | PatLynk