Statement: Patients in the primary trial treated with Fulvestrant 250 mg had a 33% higher Objective response rate than those treated with Fulvestrant 250 mg + Loading Dose.
Primary_evidence: Outcome Measurement:    Objective Response (ORR)   Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1).   Time frame: The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. Results 1:    Arm/Group Title: Fulvestrant 250 mg   Arm/Group Description: Fulvestrant 250 mg   Overall Number of Participants Analyzed: 47   Measure Type: Number   Unit of Measure: Percentage of patients  8.5        (2.4 to 20.4) Results 2:    Arm/Group Title: Fulvestrant 250 mg + Loading Dose   Arm/Group Description: Fulvestrant 250 mg + Loading Dose   Overall Number of Participants Analyzed: 51   Measure Type: Number   Unit of Measure: Percentage of patients  5.9        (1.2 to 16.2)
Secondary_evidence: Outcome Measurement:    Objective Response Rate (ORR)   An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response.   Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization   Time frame: baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008) Results 1:    Arm/Group Title: Fulvestrant 250 mg   Arm/Group Description: Fulvestrant 250 mg   Overall Number of Participants Analyzed: 45   Measure Type: Number   Unit of Measure: percentage of participants  11.1 Results 2:    Arm/Group Title: Fulvestrant 250 mg + Loading Dose   Arm/Group Description: Fulvestrant 250 mg + Loading Dose   Overall Number of Participants Analyzed: 51   Measure Type: Number   Unit of Measure: percentage of participants  17.6