Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial.

Baselga, José;Im, Seock-Ah;Iwata, Hiroji;Cortés, Javier;Campone, Mario;et.al.
(2017) The Lancet Oncology — Vol. 18, n° 7, p. 904-916 (2017)

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Authors
  • Baselga, José
    Author
  • Im, Seock-Ah
    Author
  • Iwata, Hiroji
    Author
  • Cortés, Javier
    Author
  • Vuylsteke, PeterUCLouvain
    Author
  • Campone, Mario
    Author
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Abstract
Phosphatidylinositol 3-kinase (PI3K) pathway activation is a hallmark of endocrine therapy-resistant, hormone receptor-positive breast cancer. This phase 3 study assessed the efficacy of the pan-PI3K inhibitor buparlisib plus fulvestrant in patients with advanced breast cancer, including an evaluation of the PI3K pathway activation status as a biomarker for clinical benefit.
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Citations

Baselga, J., Im, S.-A., Iwata, H., Cortés, J., De Laurentiis, M., Jiang, Z., Arteaga, C. L., Jonat, W., Clemons, M., Ito, Y., Awada, A., Chia, S., Jagiełło-Gruszfeld, A., Pistilli, B., Tseng, L.-M., Hurvitz, S., Masuda, N., Takahashi, M., Vuylsteke, P., et al. (2017). Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet Oncology, 18(7), 904-916. https://doi.org/10.1016/S1470-2045(17)30376-5 (Original work published 2017)