Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
NCT ID: NCT00387907
Last Updated: 2016-05-05
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
6 participants
INTERVENTIONAL
2006-10-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Larotaxel + Trastuzumab
larotaxel (XRP9881)
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
trastuzumab
administered as a 90-minute IV infusion on Day 1 of every week (qw)
Interventions
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larotaxel (XRP9881)
administered as a 1-hour IV infusion on Day 1 of every 3 weeks (q3w)
trastuzumab
administered as a 90-minute IV infusion on Day 1 of every week (qw)
Eligibility Criteria
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Inclusion Criteria
* Evidence that cancer has spread beyond its original location or has come back and cannot be removed by surgery
* No more than one prior treatment for advanced disease
* Her2 positive status
* Adequate liver and kidney function
* No remaining severe harmful effects to prior treatments
Exclusion Criteria
* Pregnant Women
* History of another cancer except some skin cancers and cervical cancer
* Taking other treatments for your cancer at the time you enter the trial
18 Years
FEMALE
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Winer, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Sanofi-Aventis Administrative Office
Malvern, Pennsylvania, United States
Countries
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Related Links
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Related Info
Other Identifiers
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XRP9881
Identifier Type: -
Identifier Source: secondary_id
TCD10037
Identifier Type: -
Identifier Source: org_study_id
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