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Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
June 2009
NCT00373256Uploaded 01-16-2015
Available for Download
PDS UID: Breast_Pfizer_2006_112
A Phase 3 Study Of SU011248 In Combination With Paclitaxel Versus Bevacizumab With Paclitaxel In The First-Line Advanced Disease Setting In Patients Having Breast Cancer
Provider Information
Provider Data DescriptionThe primary endpoint was to compare the progression-free survival for subjects having locally recurrent or metastatic breast cancer who receive sunitinib plus paclitaxel vs bevacizumab plus paclitaxel.
SponsorPfizer
Data ProviderPfizer
Partial set or SubsetOriginal Data
Patients in dataset488
# of Patients Control247
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/4qg5-s272
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryTo compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer
ConditionsBreast Neoplasms
Intervention TypeDrug: Sunitinib
Drug: paclitaxel
Drug: bevacizumab
Drug: paclitaxel
Drug(s)Drug: Sunitinib
Drug: paclitaxel
Drug: bevacizumab
Total Enrolled488
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionA - Experimental
B - Active Comparator
Secondary IDN/A
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Germany
Italy
Spain
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLA6181094 Protocol Final May 19 2006.doc.pdf
CRFsample-case-report-form_a6181094_10-nov-2008.pdf
DATA DICTIONARYA6181094_SPECS.xlsx
DATA (COMPARATOR ARM)adverse.sas7bdat
DATA (COMPARATOR ARM)cd_b_p.sas7bdat
DATA (COMPARATOR ARM)cn_6_p.sas7bdat
DATA (COMPARATOR ARM)cn_7_p.sas7bdat
DATA (COMPARATOR ARM)cn_8_p.sas7bdat
DATA (COMPARATOR ARM)condrug.sas7bdat
DATA (COMPARATOR ARM)contrt.sas7bdat
DATA (COMPARATOR ARM)demog.sas7bdat
DATA (COMPARATOR ARM)ecg.sas7bdat
DATA (COMPARATOR ARM)final.sas7bdat
DATA (COMPARATOR ARM)iota_p.sas7bdat
DATA (COMPARATOR ARM)lab_safe.sas7bdat
DATA (COMPARATOR ARM)pfm_p.sas7bdat
DATA (COMPARATOR ARM)phyexam.sas7bdat
DATA (COMPARATOR ARM)prevdis.sas7bdat
DATA (COMPARATOR ARM)primdiag.sas7bdat
DATA (COMPARATOR ARM)random.sas7bdat
DATA (COMPARATOR ARM)testdrug.sas7bdat
DATA (COMPARATOR ARM)tmm_p.sas7bdat
DATA (COMPARATOR ARM)vitals.sas7bdat
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