Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer - Full Text View

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: Docetaxel Drug: Capecitabine Drug: Epirubicin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Epirubicin hydrochloride Epirubicin Docetaxel Capecitabine

U.S. FDA Resources

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Compare the time to tumor progression between the two treatment arms [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Toxicity profile between the two treatment arms [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment:	272
Study Start Date:	May 2002
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 DF	Drug: Docetaxel Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles Other Name: Taxotere Drug: Epirubicin Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles Other Name: Farmorubicin
Experimental: 2 DC	Drug: Capecitabine Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles Other Name: Xeloda Drug: Docetaxel Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles Other Name: Taxotere

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

Eligibility

Ages Eligible for Study:	19 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00429871

Locations

Greece
University Hospital of Heraklion
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, 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
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

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:

Dimitris Mavrudis, MD

University Hospital of Crete, Dep of Medical Oncology

More Information

No publications provided

Responsible Party:	D.Mavrudis, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00429871 History of Changes
Other Study ID Numbers:	CT/02.09
Study First Received:	January 31, 2007
Last Updated:	May 28, 2009
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

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

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Epirubicin
Docetaxel
Capecitabine
Fluorouracil
Antibiotics, Antineoplastic

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013