Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer

Study Overview
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Brief Summary
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The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline

Detailed Description
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This trial will compare the efficacy of docetaxel plus epirubicin versus docetaxel plus capecitabine combinations as first line treatment in women with MBC

Official Title
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A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Capecitabine
* Drug: Epirubicin
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically- or cytologically- confirmed metastatic breast adenocarcinoma. No previous chemotherapy treatment for metastatic disease. No previous anthracycline treatment except as adjuvant therapy at least one year before. Age 19-75 years old Presence of measurable disease Performance status 0-2 (WHO) Adequate cardiac function (LVEF >50%) without a recent (within 6 months) history of myocardial infraction and/or unstable or uncontrolled angina. Adequate bone marrow(absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3), liver (bilirubin <1.5 times upper limit of normal and SGOT/SGPT <2 times upper limit of normal) and renal function (creatinine <2mg/dl). No previous radiotherapy to more than 25% of marrow-containing bones. Written informed consent Exclusion Criteria: Active brain metastases. Psychiatric illness or social situation that would preclude study compliance Other concurrent uncontrolled illness. Other invasive malignancy within the past 5 years except of nonmelanoma skin cancer. Positive pregnancy for premenopausal women. Concurrent antineoplastic treatment e.g. hormonal therapy

Ages Eligible for Study
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Minimum Age: 19 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>DF | Drug: Docetaxel<br>* Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles<br>* Other names: Taxotere;Drug: Epirubicin<br>* Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles<br>* Other names: Farmorubicin;|
| Experimental: 2<br>DC | Drug: Capecitabine<br>* Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles<br>* Other names: Xeloda;Drug: Docetaxel<br>* Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the time to tumor progression between the two treatment arms |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 1 year | 
| Toxicity profile between the two treatment arms |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic breast cancer;, First line chemotherapy;, Docetaxel;, Epirubicin;, Capecitabine