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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Capecitabine; Drug: Epirubicin

• Registration Number: NCT00429871
• Lead Sponsor: Hellenic Oncology Research Group

Brief Summary

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

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

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-01
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Status Verified: 2009-05
• Last Update Submitted: 2009-05-28
• Last Update Posted: 2009-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 272

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	DF
1	Epirubicin	DF
2	Docetaxel	DC
2	Capecitabine	DC

Primary Outcome Measures

Name	Time	Method
Compare the time to tumor progression between the two treatment arms	1 year

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year
Toxicity profile between the two treatment arms	1 year

Trial Locations

Locations (10)

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

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

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

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

"Metaxa's" Anticancer Hospital of Piraias; 🇬🇷 Piraeus, Greece

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

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

University Hospital of Heraklion; 🇬🇷 Heraklion, Crete, 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