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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00431106 |
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Date of registration:
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02/02/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Vinorelbine and Gemcitabine Versus Capecitabine in Pretreated Metastatic Breast Cancer
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Scientific title:
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A Multicenter Randomized Phase III Study of Combination Treatment With Vinorelbine and Gemcitabine Versus Capecitabine Monotherapy in Metastatic Breast Cancer Patients Following Treatment Failure With the Combination of a Taxane and an Anthracycline |
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Date of first enrolment:
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April 2002 |
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Target sample size:
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144 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00431106 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Greece
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Contacts
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Name:
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Dimitris Mavrudis, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital of Crete |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 19-75 years.
- Performance status World Health Organization (WHO) 0-2.
- Histologically confirmed breast adenocarcinoma.
- Clinical or radiological evidence of metastatic disease that has progressed after
combination treatment of a taxane and an anthracycline (Taxotere + Mitoxantrone or
Taxotere + Farmorubicine).
- Measurable disease.
- No metastatic central nervous system (CNS) disease.
- Less than 25% of myeloproductive bone marrow irradiated.
- Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count
> 100000/mm^3, hemoglobin > 9 gr/mm^3).
- Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times
upper limit of normal) and renal function (creatinine < 2 mg/dl).
- Informed consent.
Exclusion Criteria:
- Pregnancy or nursing.
- Positive pregnancy test.
- Psychiatric illness or social situation that would preclude study compliance.
- Other concurrent uncontrolled illness.
- Other invasive malignancy within the past 5 years except nonmelanoma skin cancer.
Age minimum:
19 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Capecitabine
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Drug: Gemcitabine
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Drug: Vinorelbine
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Primary Outcome(s)
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Time to tumor progression between the two treatment arms
[Time Frame: 1 year]
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Secondary Outcome(s)
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Overall survival
[Time Frame: 1 year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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