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Breast

A Phase 3 Study of Sunitinib in Combination with Paclitaxel versus Bevacizumab with Paclitaxel in the First-Line Advanced Disease Setting in Patients Having Breast Cancer

Unique Data Set IDBreast_Pfizer_2006_112
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients488Comparator (Control) Arm Enrolled Patients247RandomizationYesClinicalTrial.gov IDNCT00373256ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00373256?term=NCT00373256&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

A Phase 3 Study of Sunitinib in Combination with Paclitaxel versus Bevacizumab with Paclitaxel in the First-Line Advanced Disease Setting in Patients Having Breast Cancer

Trial Summary and Conditions

Randomized, open-label, Phase 3 clinical trial comparing the efficacy and safety of paclitaxel in combination with sunitinib vs paclitaxel in combination with bevacizumab as first-line treatment in subjects with advanced breast cancer. Subjects were randomly assigned (1:1) to either paclitaxel+sunitinib (Arm A) or paclitaxel+bevacizumab (Arm B). The randomization was stratified according to the following known prognostic factors: prior adjuvant chemotherapy, hormone receptor status, and disease free interval.

Data Summary

The study was terminated early due to futility after the first interim analysis as reported by investigator response.

Study Objectives

The 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.

Outcome Measures

PFS, TTP, RR

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: A6181094 Protocol Final May 19 2006.doc.pdf

CRF: sample-case-report-form_a6181094_10-nov-2008.pdf

DATA DICTIONARY: A6181094_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