Status:
TERMINATED
Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer
Lead Sponsor:
Hellenic Oncology Research Group
Collaborating Sponsors:
University Hospital of Crete
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 fa...
Detailed Description
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00431795
Start Date
June 1 2003
End Date
June 1 2012
Last Update
February 13 2013
Active Locations (10)
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1
University Hospital of Crete
Heraklion, Crete, Greece, 71110
2
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, Greece
3
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
4
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece