CClinicalTrials.gg
Sign In
TerminatedNCT00431795Updated Feb 13, 2013

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

A Phase 2 interventional study of Pegylated liposomal doxorubicin (Caelyx) and Epirubicin in Breast Cancer, sponsored by Hellenic Oncology Research Group. Terminated at 10 sites in Greece. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-02-13.

Sponsored by Hellenic Oncology Research Group · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to poor accrual
Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

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

Read the detailed description

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

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Advanced breast cancer
  • Pegylated liposomal doxorubicin
  • Epirubicin
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Hellenic Oncology Research Group is the lead sponsor of 57 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Age 18-75 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Adequate bone marrow function (Absolute neutrophil count >1000/mm\^3, Platelet count>100000/mm\^3, Hemoglobin>9gr/mm\^3)
  • Histologically- or cytologically- confirmed breast adenocarcinoma
  • No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
  • No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
  • At least 4 weeks interval since prior anticancer treatment
  • Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
  • Life expectancy > 3 months
  • Written informed consent

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or nursing
  • Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
  • Other invasive malignancy except nonmelanoma skin cancer or acute infection.
  • Radiation of measurable disease (except brain metastases)
  • Progressive brain metastases according to clinical or radiological criteria.
  • Brain metastases without prior radiation therapy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    1

    Epi

    Drug: Epirubicin

  • Experimental
    2

    Cael

    Drug: Pegylated liposomal doxorubicin (Caelyx)

Interventions

  • DrugPegylated liposomal doxorubicin (Caelyx)

    Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m\^2 IV every 4 weeks for 6 consecutive cycles

    Also known as: Caelyx

  • DrugEpirubicin

    Epirubicin (Farmorubicin) at the dose of 90mg/m\^2 IV every 3 weeks for 6 consecutive cycles

    Also known as: Farmorubicine

06

What researchers measure

Primary outcomes

  1. Assessment of antitumor efficacy by objective tumor response rates

    Time frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)

Secondary outcomes

  1. Toxicity profile and tolerance between the two treatment arms

    Time frame: Toxicity assessment of each chemotherapy cycle

  2. Time to progression

    Time frame: 1 year

  3. Overall survival

    Time frame: 1 year

07

Study locations

10 sites
  • University Hospital of Crete
    Heraklion, Crete 71110, Greece
  • University General Hospital of Alexandroupolis, Dep of Medical Oncology
    Alexandroupolis, Greece
  • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
    Athens, Greece
  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
    Athens, Greece
  • "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
    Athens, Greece
  • 401 Military Hospital of Athens
    Athens, Greece
  • Air Forces Military Hospital of Athens
    Athens, Greece
  • State General Hospital of Larissa, Dep of Medical Oncology
    Larissa, Greece
  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
    Piraeus, Greece
  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
    Thessaloniki, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00431795
Lead sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
Responsible party
Sponsor
First posted
Feb 6, 2007
Start date
Jun 2003
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Feb 13, 2013

Study contacts

Dimitris Mavrudis, MD
principal investigator · University Hospital of Crete
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Hellenic Oncology Research Group

Start the discussion