UNASSIGNED: 533 Background: Preclinical data clearly demonstrated that cyclooxigenase activates growth-promoting and anti-apoptotic pathways as well as aromatase. However, data from clinical trial are poor, mainly due to the severe restrictions that the FDA has imposed to the @entity2247 inhibitors in 2004 because of their serious adverse events. METHODS: We designed a phase III, placebo-controlled prospective trial in which postmenopausal @entity5282 positive early @entity0 (EBC) @entity1 were randomized 1:1 to receive @entity13558 (1 mg/die) upfront in combination with placebo or @entity14296 (60 mg/die). Combined treatment was planned for 24 months. @entity1 were allowed to discontinue the @entity14296 or placebo for @entity137 (censored). @entity13558 was continued for 5 years. The primary end-point was the 5-years event free survival (EFS). The secondary end-point was to compare the risk of @entity174 and the muscle-skeletal events in the two groups. Chi-Square tests for categorical data and time to event provided two-sided p values. RESULTS: Since 2003 to 2006 we enrolled 182 @entity1 . A number of 93 @entity1 was enrolled in the treatment arm and N=89 in the control. The median treatment duration was 14 months in ETAN group and 12 in PAN group. A number of 37 @entity1 in the treatment arm and 33 in the control discontinued @entity14296 after the FDA alert on @entity2247 inhibitors. To a 5 years follow-up, the median EFS was 56.9 and 53.14 months [HR: 1.9; 95%CI (1.03 - 3.59), p= .03] in the treatment arm and control, respectively. There were no significative differences in terms of fractures [RR: 0.58, 95%CI (0.14-2.38), p= .45]. @entity925 was significative lower in the treatment arm (50/73) than the control (16/67) [RR: 2.1, 95%CI (1.29-3.43), p= .002]. None of the @entity1 in the treatment arm developed serious adverse event. CONCLUSIONS: Our data demonstrated a small but significative advantage in terms of EFS and muscle-skeletal events when @entity14296 is added to @entity13558 in adjuvant setting. Data are strongly limited from the study drop-out, but the very long follow-up and the absence of major @entity137 encourage larger phase III confirmatory trials.

@entity14296 and XXXX in adjuvant early @entity0 : ETAN trial (phase III).

@entity1 :: ('9606', 'Species') :: ['women', 'Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity0 :: ('MESH:D001943', 'Disease') :: ['breast cancer'] @entity174 :: ('MESH:D050723', 'Disease') :: ['fracture'] @entity14296 :: ('MESH:C422649', 'Chemical') :: ['etoricoxib'] @entity13558 :: ('MESH:C090450', 'Chemical') :: ['Anastrozole', 'anastrozole'] @entity2247 :: ('4513', 'Gene') :: ['COX-2'] @entity925 :: ('MESH:D063806', 'Disease') :: ['Muscle-skeletal pain'] @entity5282 :: ('3164', 'Gene') :: ['hormone-receptor']
@entity13558 :: (MESH:C090450,Chemical) :: ['anastrozole']
