- Bayer ( OTCPK:BAYZF ) ( OTCPK:BAYRY ) on Monday said it expanded the late-stage development program for elinzanetant by starting a phase 3 study in patients with breast cancer and women with high risk for breast cancer with vasomotor symptoms (VMS) caused by endocrine therapy.
- VMS, also called hot flashes/flushes and night sweats, are symptoms of menopause. The company noted that VMS is a known adverse reaction of endocrine therapy, which is given to certain women as an adjuvant treatment or primary prevention therapy for breast cancer.
- The phase 3 trial, dubbed OASIS 4, intends to randomize ~400 patients at about 95 centers in 15 countries to evaluate elinzanetant 120 mg once daily as non-hormonal treatment for these patients.
- The German conglomerate said that in August 2021, the OASIS phase 3 program started evaluating elinzanetant 120 mg once daily in menopausal women with vasomotor symptoms.
For further details see:
Bayer starts phase 3 trial of elinzanetant in breast cancer patients with menopause symptoms