Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

Back to the List
Type(s) of Cancer
Breast
Study Phase
Phase 3
Study Completion Date
December 2009
NCT00435409Uploaded 01-16-2015
Available for Download
PDS UID: Breast_Pfizer_2007_113
A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer
Provider Information
Provider Data DescriptionThe primary endpoint was progression-free survival. Other objectives were RR and OS.
SponsorPfizer
Data ProviderPfizer
Partial set or SubsetOriginal Data
Patients in dataset442
# of Patients Control143
# of Patients ExperimentalN/A
DOIhttps://doi.org/10.34949/zcgz-t010
CDISC StandardRaw or Case Report Form data
Study ArmsComparator arm data only
Clinical Trials.gov Information
Brief SummaryThe treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.
ConditionsBreast Neoplasms
Intervention TypeDrug: Sunitinib + Capecitabine
Drug: Capecitabine
Drug(s)Drug: Sunitinib + Capecitabine
Drug: Capecitabine
Total Enrolled442
RandomizationRandomized
Blinding MethodNone (Open Label)
Arms InterventionA - Experimental
B - Active Comparator
Secondary IDN/A
PubMed (PMID)23857972
Collaborator(s)N/A
Region(s)United States
Austria
Belgium
Canada
Czech Republic
Denmark
France
Germany
Greece
Ireland
Italy
Netherlands
Norway
Poland
Romania
Russian Federation
Spain
United Kingdom
Age Range18 Years and older (Adult, Older Adult)
Files:
PROTOCOLA6181099 FINAL protocol 06 October 2006.doc.pdf
CRFA6181099_Final Expanded CRF.pdf
DATA DICTIONARYA6181099_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
© 2024 Project Data Sphere
All rights reserved
Privacy PolicyTerms of Use