A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

• Progression Free Survival (PFS) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) or death ] [ Designated as safety issue: No ]
  PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.
  
  

• Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) ] [ Designated as safety issue: No ]
  OR=from start of treatment until disease progression/recurrence. Complete response (CR)=disappearance of all target lesions. Partial response (PR)= ? 30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD)= ? 20% increase in sum of longest dimensions of lesions taking as reference smallest sum of the longest dimensions since treatment started, or appearance of ? 1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
  
  
• Duration of Response (DR) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer ] [ Designated as safety issue: No ]
  DR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or to death on study. If tumor progression data included more than 1 date, the first date was used. DR was to be calculated as (the end date for DR - first CR or PR that was subsequently confirmed +1)/7.
  
  
• Overall Survival (OS) [ Time Frame: From start of study treatment until death ] [ Designated as safety issue: No ]
  OS was defined as the time from date of enrollment to date of death due to any cause. OS was to be calculated as (the event date - the date of enrollment +1)/7.
  
  
• Time to Tumor Progression (TTP) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) ] [ Designated as safety issue: No ]
  TTP was defined as the time from enrollment to first documentation of objective tumor progression. If tumor progression data included more than 1 date, the first date was used. TTP was to be calculated as (first event date - the date of enrollment +1)/7.
  
  
• Clinical Benefit Rate (CBR) [ Time Frame: From start of treatment until Day 1 of every other cycle (8 weeks) ] [ Designated as safety issue: No ]
  The clinical benefit rate (CBR) was the measure for clinical benefit (CB) and was defined as the percent of subjects with confirmed CR or confirmed PR, or confirmed SD according to RECIST, relative to the total analysis population. CRs were those that persisted on repeat imaging study ?4 weeks after initial documentation of response.
  
  

The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.