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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: |
NCT00386685 |
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Date of registration:
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10/10/2006 |
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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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XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
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Scientific title:
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Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC) |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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51 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00386685 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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France
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Sweden
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Switzerland
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Contacts
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Name:
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Henri Roche, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Claudius Regaud - Toulouse - France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Metastatic breast cancer (MBC)
- 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:
- More than one previous chemotherapy regimen for metastatic disease
- Cardiac dysfunction
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Neoplasms
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Intervention(s)
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Drug: trastuzumab
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Drug: larotaxel (XRP9881)
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Primary Outcome(s)
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Response rate (best overall response under treatment)
[Time Frame: study period]
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Secondary Outcome(s)
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Incidence of grade 3-4 toxicities, pharmacokinetic interaction
[Time Frame: study period]
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Secondary ID(s)
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TCD6595
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XRP9881
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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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