Ribociclib effective in HR+, HER2 breast cancer

Newly published data from the MONALEESA-3 trial demonstrate that ribociclib is effective in patients with HR+/ HER2 breast cancer. In this trial, 726 postmenopausal women with disease relapse >12 months after completion of endocrine therapy were randomized in a 2:1 ratio to receive fulvestrant plus ribociclib or fulvestrant alone. Patients in the ribociclib plus fulvestrant group had a median progression-free survival (PFS) duration of 20.5 months versus 12.8 months (hazard ratio 0.59, 95% CI 0.48–0.73; P < 0.001). Improvements in PFS in the ribociclib group were accompanied by increased risks of several grade 3 adverse events including neutropenia (46.6% versus 0%) and leukopenia (13.5% versus 0%), in addition to grade 4 neutropenia (6.8% versus 0%). These findings demonstrate the superiority of the addition of ribociclib to fulvestrant monotherapy in this setting.


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  1. Slamon, D. J. et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J. Clin. Oncol. (2018)

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Correspondence to Peter Sidaway.

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Sidaway, P. Ribociclib effective in HR+, HER2 breast cancer. Nat Rev Clin Oncol 15, 532 (2018).

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