Statement: The Ridaforolimus + Dalotuzumab + Exemestane group of the primary trial had a median PFS of over 38.43 months.
Primary_evidence: Outcome Measurement:    1. Progression-free Survival (PFS) According to Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Based on Blinded Independent Central Review (BICR)   PFS was defined as the time from randomization to progressive disease, or death, whichever occurs first. Response was assessed according to RECIST 1.1 by BICR. According to RECIST 1.1, progressive disease (PD) was defined as a 20% relative increase in the sum of diameters (SOD) of target lesions, taking as reference the nadir SOD and an absolute increase of >5 mm in the SOD, or the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and median PFS (95% confidence interval [CI]) in weeks was reported for each treatment arm. Per protocol, participants remained on assigned treatment until disease progression. Participants who discontinued study treatment for reasons other than disease progression continued to be assessed by imaging until objective documentation of progression. All participants (including participants who discontinued study treatment) were followed for survival until investigator notification to discontinue.   Time frame: From Day 1 through last post-study efficacy follow-up (up to ~19 months) Results 1:    Arm/Group Title: Ridaforolimus + Dalotuzumab + Exemestane   Arm/Group Description: Participants received ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity.   Overall Number of Participants Analyzed: 40   Median (95% Confidence Interval)   Unit of Measure: Weeks  23.29        (8.71 to 38.43) Results 2:    Arm/Group Title: Ridaforolimus + Exemestane   Arm/Group Description: Participants received ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.   Overall Number of Participants Analyzed: 40   Median (95% Confidence Interval)   Unit of Measure: Weeks  31.86        (16.00 to 39.29)