Safety of @entity4381 and incidence of XXXX of the jaw (ONJ) during adjuvant therapy in a randomised phase III trial (AZURE: BIG 01-04) for @entity1 with @entity0 .

@entity5921 @entity1 @entity0 @entity4381 @entity2530
The AZURE trial is an ongoing phase III, academic, multi-centre, randomised trial designed to evaluate the role of @entity4381 ( @entity5921 ) in the adjuvant therapy of @entity1 with @entity0 . Here, we report the safety and tolerability profile of @entity5921 in this setting. Eligible @entity1 received (neo)adjuvant chemotherapy and/or endocrine therapy and were randomised to receive neither additional treatment nor intravenous @entity5921 4 mg. @entity5921 was administered after each chemotherapy cycle to exploit potential sequence-dependent synergy. @entity5921 was continued for 60 months post-randomisation (six doses in the first 6 months, eight doses in the following 24 months and five doses in the final 30 months). Serious (SAE) and non-serious adverse event (AE) data generated during the first 36 months on study were analysed for the safety population. 3,360 @entity1 were recruited to the AZURE trial. The safety population comprised 3,340 @entity1 ( @entity5921 1,665; control 1,675). The addition of @entity5921 to standard treatment did not significantly impact on chemotherapy delivery. SAE were similar in both treatment arms. No significant safety differences were seen apart from the occurrence of @entity2530 of the jaw (ONJ) in the @entity5921 group (11 confirmed cases; 0.7%; 95% confidence interval 0.3-1.1%). @entity5921 in the adjuvant setting is well tolerated, and can be safely administered in addition to adjuvant therapy including chemotherapy. The adverse events were consistent with the known safety profile of @entity5921 , with a low incidence of ONJ.
