A phase III clinical study of fezolinetant, for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy, has been initiated by Astellas Pharma.

HIGHLIGHT 1 is a randomised, placebo-controlled, double-blind, phase III clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe vasomotor symptoms (VMS )in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. 

Approximately 540 participants are planned to be randomised 1:1 to fezolinetant or placebo at up to 100 sites globally. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks.

Fezolinetant is an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe VMS in women with breast cancer receiving adjuvant endocrine therapy. 

The safety and efficacy of fezolinetant have not been established in this patient population. 

Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the hypothalamus to reduce the number and intensity of VSMs such as hot flushes and night sweats.