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Breast

A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

Unique Data Set IDBreast_Pfizer_2007_113
DownloadableYes
SponsorPfizerData ProviderPfizerTotal Study Enrolled Patients442Comparator (Control) Arm Enrolled Patients143RandomizationYesClinicalTrial.gov IDNCT00435409ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00435409?term=NCT00435409&rank=1
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugData Set TypeSDTM

Clinical Trial Title

A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

Trial Summary and Conditions

Randomized, phase 3 clinical trial comparing the efficacy and safety of the combination capecitabine plus sunitinib with capecitabine in patients with advanced breast cancer. Patients eligible for this study will have previously received treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting; if the disease-free interval was longer than 12 months following adjuvant therapy, patients must have received treatment with 1 chemotherapy regimen in the first-line advanced disease setting. Patients having HER2 positive disease will be eligible if they have previously received HER-2 targetted treatment as appropriate. Randomization will be stratified according to the number of metastatic organ systems (??2 vs >2 sites), receptor status (triple negative (HER2-/ER-/PR-) vs all others), and number of prior chemotherapy regimens (1 vs >1).

Data Summary

Progression-free survival was not significantly different between the treatment arms, with medians of 5.5 months (95% CI, 4.5 to 6.0) for the sunitinib plus capecitabine arm and 5.9 months (95% CI, 5.4 to 7.6) for the capecitabine monotherapy arm (hazard ratio, 1.22; 95% CI, 0.95 to 1.58; one-sided P = .941). There were no significant differences in response rate or overall survival. Toxicity, except for hand-foot syndrome, was more severe in the combination arm.

Study Objectives

The primary endpoint was progression-free survival. Other objectives were RR and OS.

Outcome Measures

N/A

Available Downloads:

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

PROTOCOL: A6181099 FINAL protocol 06 October 2006.doc.pdf

CRF: A6181099_Final Expanded CRF.pdf

DATA DICTIONARY: A6181099_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