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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01091168 |
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Date of registration:
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03/02/2010 |
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Primary sponsor: |
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Public title:
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Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer
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Scientific title:
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Date of first enrolment:
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September 2009 |
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Target sample size:
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594 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01091168 |
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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: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Austria
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Belarus
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Belgium
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France
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Germany
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Italy
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Portugal
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Russian Federation
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South Africa
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Spain
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Taiwan
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Ukraine
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:(main conditions)
- Female patients 18 to 75 years of age with metastatic breast cancer
histologically/cytologically confirmed not amenable to curative surgery or
radiotherapy and who have received at least two prior chemotherapy regimens including
anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate
for these drugs,
- Karnofsky performance score of at least 70 %, adequate haematological, hepatic and
renal functions and ECG without clinically relevant abnormality.
Exclusion Criteria:
- Concurrent serious uncontrolled medical disorder,
- known or clinical evidence of brain metastases or leptomeningeal involvement,
- pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,
- history of second primary malignancy,
- HIV infection, preexisting neuropathy,
- pregnancy or breast feeding.
Age minimum:
18 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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Metastases
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Intervention(s)
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Drug: alkylating agent of physician choice registered in cancer
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Drug: vinflunine
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Primary Outcome(s)
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Overall survival
[Time Frame: monthly for 6 months after disease progression and then every 3 months]
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Secondary Outcome(s)
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Adverse event profile
[Time Frame: monthly]
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Progression free survival
[Time Frame: every 6 weeks until disease progression]
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Quality of life questionnaire
[Time Frame: every 6 weeks]
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Tumour response rate
[Time Frame: every 6 weeks until disease progression]
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Secondary ID(s)
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L00070 IN 308 B0
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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