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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00429871

Enrollment

272

Registered

2007-02-01

Start date

2002-05-31

Completion date

2007-11-30

Last updated

2009-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Metastatic breast cancer;, First line chemotherapy;, Docetaxel;, Epirubicin;, Capecitabine

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

Interventions

DRUGDocetaxel

Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

DRUGCapecitabine

Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles

DRUGEpirubicin

Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

19 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Compare the time to tumor progression between the two treatment arms	1 year

Secondary

Measure	Time frame
Overall survival	1 year
Toxicity profile between the two treatment arms	1 year

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026