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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Epirubicin; Drug: Pegylated liposomal doxorubicin (Caelyx)

• Registration Number: NCT00431795
• Lead Sponsor: Hellenic Oncology Research Group

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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2007-02-05
• Study First Submitted QC: 2007-02-05
• Study First Posted: 2007-02-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-12
• Last Update Posted: 2013-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 100

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

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Epirubicin	Epi
2	Pegylated liposomal doxorubicin (Caelyx)	Cael

Primary Outcome Measures

Name	Time	Method
Assessment of antitumor efficacy by objective tumor response rates	Objective responses confirmed by CT or MRI (on 3rd and 6th cy)

Secondary Outcome Measures

Name	Time	Method
Toxicity profile and tolerance between the two treatment arms	Toxicity assessment of each chemotherapy cycle
Time to progression	1 year
Overall survival	1 year

Trial Locations

Locations (10)

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

State General Hospital of Larissa, Dep of Medical Oncology; 🇬🇷 Larissa, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, 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

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology; 🇬🇷 Athens, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece