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

Information source: Hellenic Oncology Research Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Docetaxel (Drug); Capecitabine (Drug); Epirubicin (Drug); Docetaxel (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hellenic Oncology Research Group

Official(s) and/or principal investigator(s):
Dimitris Mavrudis, MD, Principal Investigator, Affiliation: University Hospital of Crete, Dep of Medical Oncology


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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Compare the time to tumor progression between the two treatment arms

Secondary outcome:

Overall survival

Toxicity profile between the two treatment arms

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


Minimum age: 19 Years. Maximum age: 75 Years. Gender(s): Female.


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


- 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

Locations and Contacts

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupolis, 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

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology, Athens, Greece

401 Military Hospital of Athens, Athens, Greece

Air Forces 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 Hospital of Heraklion, Heraklion, Crete 71110, Greece

Additional Information

Starting date: May 2002
Last updated: May 28, 2009

Page last updated: August 23, 2015

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