Statement: 20 patients treated with Dasatinib and Letrozole in the primary trial had a Disease Free Interval (DFI) Greater Than 2 Years.
Primary_evidence: Outcome Measurement:    Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population   CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.   Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) Results 1:    Arm/Group Title: Dasatinib Plus Letrozole   Arm/Group Description: Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years   Dasatinib 100 mg + Letrozole 2.5 mg   Patients on letrozole plus dasatinib received both drugs until progressive disease (PD) or intolerable toxicity. If the intolerable toxicity was determined to be related to dasatinib, dasatinib was discontinued and the patient continued on single-agent letrozole. Although drugs were taken daily, cycle length was 28-days   Overall Number of Participants Analyzed: 56   Measure Type: Number   Unit of Measure: participants  CBR (CR+PR+SD): 40   CBR, DFI <= 2 Years: 20 CBR, DFI > 2 Years: 20 Results 2:    Arm/Group Title: Letrozole   Arm/Group Description: Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years   Patients on letrozole who developed progressive disease continued letrozole, and dasatinib was added to their treatment regimen. Although drugs were taken daily, cycle length was 28-days   Overall Number of Participants Analyzed: 61   Measure Type: Number   Unit of Measure: participants  CBR (CR+PR+SD): 40   CBR, DFI <= 2 Years: 20 CBR, DFI > 2 Years: 20