Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
NCT ID: NCT00429871
Last Updated: 2009-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
272 participants
INTERVENTIONAL
2002-05-31
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
DF
Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Epirubicin
Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
2
DC
Capecitabine
Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Interventions
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Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Capecitabine
Capecitabine 950 mg/m2 orally twice a day on days 1-14 every 3 weeks for 6 consecutive cycles
Epirubicin
Epirubicin at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Docetaxel
Docetaxel at the dose of 75mg/m2 IV on day 1 every 3 weeks for 6 consecutive cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
75 Years
FEMALE
No
Sponsors
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University Hospital of Crete
OTHER
Hellenic Oncology Research Group
OTHER
Responsible Party
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Hellenic Oncology Research Group
Principal Investigators
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Dimitris Mavrudis, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Crete, Dep of Medical Oncology
Locations
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University Hospital of Heraklion
Heraklion, Crete, Greece
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupoli, , 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
Countries
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References
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Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
Other Identifiers
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CT/02.09
Identifier Type: -
Identifier Source: org_study_id