Hyams, trial summary    PDF trial summary

A randomised clinical trial investigating the effect of cediranib + fulvestrant versus fulvestrant in

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NCT00454805    Invest New Drugs 2013;31:1345-54  



Studied treatment
Control treatment



Patients
Group sizes-9 / -9



Blindness Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Design



EndpointX1N1X0N0TE95% CI objective response - -9 - -9 no data progression-free survival (PFS) - -9 - -9 no data overall survival (OS) - -9 - -9 no data treatment-related deaths - -9 - -9 no data hypertension (grade 3) - -9 - -9 no data arterial thromboembolic event - -9 - -9 no data gastrointestinal perforation (grade 3) - -9 - -9 no data left ventricular systolic dysfunction (grade 2 or 3) - -9 - -9 no data high-grade congestive heart failure - -9 - -9 no data serious adverse events - -9 - -9 no data arterial/venous thromboembolism (grade 3) - -9 - -9 no data pulmonary embolism (grade 3) - -9 - -9 no data bleeding (grade 3) - -9 - -9 no data cardiomyopathy (grade 3) - -9 - -9 no data permanent discontinuation - -9 - -9 no data adverse events grade 3 - -9 - -9 no data venous thromboembolic event (grade 3) - -9 - -9 no data proteinuria (grade 3) - -9 - -9 no data wound-healing complications (grade 3) - -9 - -9 no data0,22,01,0

Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs 2013;31:1345-54     [PMID: 23801303]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT00454805



Registering number NCT00454805 (see trial on clinicaltrials.gov)
Code Name