PURPOSE: To compare @entity1349 ( @entity1349 ) for @entity1299 500 mg versus @entity13558 as first-line endocrine therapy for advanced @entity0 . @entity1 AND METHODS: The @entity1299 First-Line Study Comparing Endocrine Treatments (FIRST) was a phase II, randomized, open-label, multicenter trial. Postmenopausal @entity1 with @entity172 receptor-positive, locally advanced/metastatic @entity0 who had no previous therapy for advanced disease received either @entity1299 500 mg (days 0, 14, 28, and every 28 days thereafter) or @entity13558 1 mg (daily). The primary end point (clinical benefit rate [72.5% and 67.0%]) and a follow-up analysis (median time to progression [23.4 months and 13.1 months]) have been reported previously for @entity1299 500 mg and @entity13558 , respectively. Subsequently, the protocol was amended to assess @entity1349 by unadjusted log-rank test after approximately 65% of @entity1 had died. Treatment effect on @entity1349 across several subgroups was examined. Tolerability was evaluated by adverse event monitoring. RESULTS: In total, 205 @entity1 were randomly assigned ( @entity1299 500 mg, n = 102; @entity13558 , n = 103). At data cutoff, 61.8% ( @entity1299 500 mg, n = 63) and 71.8% ( @entity13558 , n = 74) had died. The hazard ratio (95% CI) for @entity1349 with @entity1299 500 mg versus @entity13558 was 0.70 (0.50 to 0.98; P = .04; median @entity1349 , 54.1 months v 48.4 months). Treatment effects seemed generally consistent across the subgroups analyzed. No new safety issues were observed. CONCLUSION: There are several limitations of this @entity1349 analysis, including that it was not planned in the original protocol but instead was added after time-to-progression results were analyzed, and that not all @entity1 participated in additional @entity1349 follow-up. However, the present results suggest @entity1299 500 mg extends @entity1349 versus @entity13558 . This finding now awaits prospective confirmation in the larger phase III FALCON ( @entity1299 and @entity13558 Compared in Hormonal Therapy Na  ve Advanced @entity0 ) trial (ClinicalTrials.gov identifier: NCT01602380).

@entity1299 500 mg Versus @entity13558 1 mg for the First-Line Treatment of Advanced XXXX : Overall Survival Analysis From the Phase II FIRST Study.

@entity1 :: ('9606', 'Species') :: ['women', 'patients', 'PATIENTS'] @entity172 :: ('MESH:D004967', 'Chemical') :: ['estrogen'] @entity0 :: ('MESH:D001943', 'Disease') :: ['Breast Cancer', 'breast cancer'] @entity13558 :: ('MESH:C090450', 'Chemical') :: ['Anastrozole', 'anastrozole'] @entity1299 :: ('MESH:C070081', 'Chemical') :: ['Fulvestrant', 'fulvestrant'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity0 :: (MESH:D001943,Disease) :: ['Breast Cancer']
