Therapy Areas: Oncology
Astellas initiates Phase 3 study for fezolinetant in breast cancer patients
27 August 2024 -

Japanese pharmaceutical company Astellas Pharma Inc (TSE:4503) reported on Tuesday that the first patient has been dosed in a Phase 3 clinical study to evaluate fezolinetant, a potential treatment for moderate to severe hot flashes and night sweats in women with breast cancer receiving adjuvant endocrine therapy.

Involving approximately 540 participants, the HIGHLIGHT 1 study will assess the efficacy and safety of fezolinetant in reducing the frequency and severity of vasomotor symptoms (VMS). These symptoms are recognised as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer.

The primary endpoints include changes in VMS frequency and severity at weeks 4 and 12.

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