XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
NCT ID: NCT00386685
Last Updated: 2011-04-12
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
PHASE2
51 participants
INTERVENTIONAL
2006-07-31
2011-01-31
Brief Summary
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The secondary objectives are safety and pharmacokinetic interaction
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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larotaxel (XRP9881)
intravenous administration
trastuzumab
intravenous administration
Eligibility Criteria
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Inclusion Criteria
* HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
* Adequate organs functions
Exclusion Criteria
* Cardiac dysfunction
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Henri Roche, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Claudius Regaud - Toulouse - France
Locations
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Sanofi-Aventis Administrative Office
Diegem, , Belgium
Sanofi-Aventis Administrative Office
Paris, , France
Sanofi-Aventis Administrative Office
Bromma, , Sweden
Sanofi-Aventis Administrative Office
Geneva, , Switzerland
Countries
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Other Identifiers
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XRP9881
Identifier Type: -
Identifier Source: secondary_id
TCD6595
Identifier Type: -
Identifier Source: org_study_id
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