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Breast

Phase III Randomized, Multi Center Study of Sunitinib Malate or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Unique Data Set IDBreast_Pfizer_2006_111
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients482Comparator (Control) Arm Enrolled Patients244RandomizationYesClinicalTrial.gov IDNCT00373113ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00373113?term=NCT00373113&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

Phase III Randomized, Multi Center Study of Sunitinib Malate or Capecitabine in Subjects with Advanced Breast Cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Trial Summary and Conditions

Phase III trial comparing the efficacy and safety of sunitinib malate versus capecitabine monotherapy in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated. The primary endpoint was progression-free survival (PFS) of subjects receiving sunitinib at a starting dose of 37.5 mg orally once daily compared to those recieiving capecitabine at a dose of 1250 or 1000 (in patients older than 65 years) mg/m2 twice a day for 2 consecutive weeks, followed by a 1-week rest period and given as 3 weeks cycles.

Data Summary

Patient enrollment in this trial was discontinued based on statistical assessment for futility by an independent Data Monitoring Committee.

Study Objectives

The primary endpoint was progression-free survival (PFS) of subjects receiving sunitinib at a starting dose of 37.5 mg orally once daily compared to those recieiving capecitabine at a dose of 1250 or 1000 (in patients older than 65 years) mg/m2 twice a day for 2 consecutive weeks, followed by a 1-week rest period and given as 3 weeks cycles. Secondary Objectives: to assess time to tumor progression, overall response, duration of response, time to tumor response, overall survival, patient reported outcomes, and safety

Outcome Measures

PFS, TTP, ORR, OS

Available Downloads:

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

PROTOCOL: A6181107 Protocol Final 21 June 2006.doc

CRF: sample-case-report-form_a6181107_27-apr-2009.pdf

DATA DICTIONARY: A6181107_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): srv_p.sas7bdat

DATA (COMPARATOR ARM): testdrug.sas7bdat

DATA (COMPARATOR ARM): tmm_p.sas7bdat

DATA (COMPARATOR ARM): vitals.sas7bdat