Statement: the primary trial and the secondary trial have non-comparable outcome measurements for their results
Primary_evidence: Outcome Measurement:    Percent Change in Net Influx Constant (Ki) by FLT PET   Percent change between pre-treatment (baseline) and post-therapy PET measurements in breast tumors will be computed.   Association between Ki-67 and Ki by FLT (KFLT) decline will be analyzed using the mid-P adjustment to Fisher's exact test to evaluate the potential clinical utility of change in FLT as a biomarker for early response, using Ki-67 as the standard for early response.   Time frame: Baseline to up to 6 weeks Results 1:    Arm/Group Title: Diagnostic (FLT PET)   Arm/Group Description: Patients with early stage, ER positive primary breast cancer undergo FLT PET scan at baseline and 1-6 weeks after the start of standard endocrine treatment. The surgery follows 1-7 days after the second FLT PET scan.   Tracer used in the FLT PET (positron emission tomography) scanning procedure: [F18] fluorothymidine.   Positron Emission Tomography: Undergo FLT PET   Laboratory Biomarker Analysis: Correlative studies - Ki67 staining of the tumor tissue in the biopsy and surgical specimen.   Overall Number of Participants Analyzed: 28   Median (Full Range)   Unit of Measure: % change  -32.0        (-82.4 to 3953.7)
Secondary_evidence: Outcome Measurement:    Progression-Free Survival (PFS) as Assessed by Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)   PFS was defined as the time from randomization to disease progression as determined by the investigator with the use of RECIST v1.1 or death due to any cause, whichever occurred earlier. Disease progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). For non-target lesions, disease progression was defined as unequivocal progression of existing lesions. The appearance of one or more new lesions was also considered progression.   Time frame: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs earlier (up to the 15 Oct 2017 data cutoff, approximately 2.5 years) Results 1:    Arm/Group Title: Placebo+Fulvestrant   Arm/Group Description: Participants received placebo taken orally QD beginning at Cycle 1, Day 1, and fulvestrant 500 mg administered by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.   Overall Number of Participants Analyzed: 176   Median (95% Confidence Interval)   Unit of Measure: months  5.39        (3.68 to 7.29) Results 2:    Arm/Group Title: Taselisib+Fulvestrant   Arm/Group Description: Participants received taselisib 4 mg taken orally QD beginning at Cycle 1, Day 1 and fulvestrant 500 mg by IM injection at Cycle 1, Days 1 and 15, and then on Day 1 of each subsequent 28-day cycle until disease progression, unacceptable toxicity, or study termination by the Sponsor.   Overall Number of Participants Analyzed: 340   Median (95% Confidence Interval)   Unit of Measure: months  7.43        (7.26 to 9.07)