- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00429871
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
May 28, 2009 updated by: Hellenic Oncology Research Group
A Multicenter Randomized Comparative Study of Docetaxel Plus Epirubicin Versus Docetaxel Plus Capecitabine Combinations as First Line Treatment of Metastatic Breast Cancer
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
272
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Alexandroupolis, Greece
- University General Hospital of Alexandroupolis, Dep of Medical Oncology
-
Athens, Greece
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
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Athens, Greece
- "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
-
Athens, Greece
- "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
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Athens, Greece
- 401 Military Hospital of Athens
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Athens, Greece
- Air Forces Military Hospital of Athens
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Larissa, Greece
- State General Hospital of Larissa, Dep of Medical Oncology
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Piraeus, Greece
- "Metaxa's" Anticancer Hospital of Piraias
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Thessaloniki, Greece
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
-
-
Crete
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Heraklion, Crete, Greece, 71110
- University Hospital Of Heraklion
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
DF
|
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Other Names:
Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Other Names:
|
Experimental: 2
DC
|
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Other Names:
Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Compare the time to tumor progression between the two treatment arms
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 1 year
|
1 year
|
Toxicity profile between the two treatment arms
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dimitris Mavrudis, MD, University Hospital of Crete, Dep of Medical Oncology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2002
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
January 31, 2007
First Submitted That Met QC Criteria
January 31, 2007
First Posted (Estimate)
February 1, 2007
Study Record Updates
Last Update Posted (Estimate)
May 29, 2009
Last Update Submitted That Met QC Criteria
May 28, 2009
Last Verified
May 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Docetaxel
- Capecitabine
- Epirubicin
Other Study ID Numbers
- CT/02.09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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