A randomized adaptive phase II/III study of buparlisib, a pan-Class I PI3K inhibitor, combined with paclitaxel for the treatment of HER2- advanced breast cancer (BELLE-4)

In the randomized, adaptive phase II/III BELLE-4 study, addition of buparlisib to paclitaxel did not improve progression free survival compared with paclitaxel alone in women with human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer at adaptive interim analysis. The trial was stopped for futility at the end of phase II, and phase III was not initiated.

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