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

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

Official Title
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A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Pegylated liposomal doxorubicin (Caelyx)
* Drug: Epirubicin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Epi | Drug: Epirubicin<br>* Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles<br>* Other names: Farmorubicine;|
| Experimental: 2<br>Cael | Drug: Pegylated liposomal doxorubicin (Caelyx)<br>* Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles<br>* Other names: Caelyx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of antitumor efficacy by objective tumor response rates |  | Objective responses confirmed by CT or MRI (on 3rd and 6th cy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity profile and tolerance between the two treatment arms |  | Toxicity assessment of each chemotherapy cycle | 
| Time to progression |  | 1 year | 
| Overall survival |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced breast cancer, Pegylated liposomal doxorubicin, Epirubicin