Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
NCT ID: NCT00372424
Last Updated: 2012-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
26 participants
INTERVENTIONAL
2006-12-31
2011-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Combination of SU011248 (37.5 mg once daily \[Schedule 2/1\]) with docetaxel (75 mg/m2 every 3 weeks) and trastuzumab (therapeutic dose)
Herceptin
Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.
Sunitinib
SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.
Taxotere
The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
Interventions
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Herceptin
Trastuzumab will be administered intravenously on Day 1 before docetaxel - loading dose of 4 mg/kg over 90-minute on Day 1 followed by weekly maintenance doses of 2 mg/kg on Days 1, 8, 15 given as 30-minute infusions if the initial loading dose was well tolerated. Loading dose of 8 mg/kg over 90-minute on Day 1 followed by 3-weekly maintenance doses of 6 mg/kg given as 90-minute infusions. The administration of 6 mg/kg will be repeated on Day 1 every 3 weeks.
Sunitinib
SU011248 will be administered at 37.5 mg once daily for 2 weeks every 3 weeks (Schedule 2/1) starting from Day 2, when in combination with docetaxel. SU011248 will be administered at the starting dose of 37.5 mg daily in a continuous regimen when docetaxel is discontinued.
Taxotere
The starting dose of docetaxel will be 75 mg/m2 every 3 weeks, administered on Day 1 of each cycle as a 1-hour IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tumors over-expressing Her-2
* Candidate for treatment with docetaxel/trastuzumab
Exclusion Criteria
* AST and/or ALT \>1.5 x ULN concomitant with ALP \>2.5 x ULN
18 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Brussels, , Belgium
Pfizer Investigational Site
Charleroi, , Belgium
Pfizer Investigational Site
Sint-Niklaas, , Belgium
Pfizer Investigational Site
Wilrijk, , Belgium
Pfizer Investigational Site
Meldola, FC, Italy
Pfizer Investigational Site
Milan, , Italy
Countries
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References
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Cardoso F, Canon JL, Amadori D, Aldrighetti D, Machiels JP, Bouko Y, Verkh L, Usari T, Kern KA, Giorgetti C, Dirix L. An exploratory study of sunitinib in combination with docetaxel and trastuzumab as first-line therapy for HER2-positive metastatic breast cancer. Breast. 2012 Dec;21(6):716-23. doi: 10.1016/j.breast.2012.09.002. Epub 2012 Sep 27.
Related Links
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Other Identifiers
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A6181113
Identifier Type: -
Identifier Source: org_study_id