Vasomotor symptoms (VMS) are common side-effects experienced by women receiving adjuvant endocrine therapy for hormone receptor-positive (HR+) breast cancer that can have a substantial impact on quality of life and may lead to the discontinuation of therapy. Hormone therapy is contraindicated in women with HR+ breast cancer, and there is an unmet need for well-tolerated and effective nonhormonal treatments to safely address these symptoms. Elinzanetant is a selective neurokinin-1,3 receptor antagonist currently being evaluated for the treatment of VMS associated with menopause in the phase III OASIS program.
OASIS 4 (NCT05587296) is an ongoing, multicentre, multicountry, double-blind, randomized, placebo-controlled, phase III study evaluating the efficacy and safety of elinzanetant 120 mg in women aged 18–70 years at high risk of developing or with a personal history of HR+ breast cancer receiving tamoxifen or aromatase inhibitors. Participants recording at least 35 moderate or severe VMS over 7 days are suitable for inclusion. Following a 6-week screening period, approximately 405 participants will be randomised at a 2:1 ratio to receive either once-daily elinzanetant 120 mg for 52 weeks or a matching placebo for 12 weeks followed by elinzanetant 120 mg for 40 weeks. After treatment, participants will undergo a 4-week follow up. Primary endpoints are the mean change in moderate or severe VMS frequency from baseline to weeks 4 and 12. Key secondary endpoints are mean change in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) 8b and Menopause-Specific Quality-of-Life (MENQOL) questionnaire from baseline to week 12. Other secondary endpoints are mean change in moderate or severe VMS severity from baseline to weeks 4 and 12 and moderate or severe VMS frequency from baseline to week 1 and over time. Primary and key secondary endpoints will be analysed using a mixed model with repeated measures. Safety will be primarily assessed using adverse event reporting throughout the duration of the study.
NCT05587296.
Medical writing assistance was provided by Emma Case, Highfield, Oxford, UK with sponsorship from Bayer.
Bayer.
Bayer AG.
F. Cardoso: Financial Interests, Personal, Other, Consultancy: Amgen, Astellas/Medivation, AstraZeneca, Celgene, Daiichi Sankyo, Eisai, GE Oncology, Genentech, GlaxoSmithKline, Macrogenics, Medscape, Merck-Sharp, Merus BV, Mylan, Mundipharma, Novartis, Pfizer, Pierre-Fabre, Prime Oncology, Roche, Sanofi, Samsung Bioepis, Seagen, Teva; Financial Interests, Personal, Advisory Board: Gilead, IQVIA, Touchime; Financial Interests, Institutional, Invited Speaker: Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol Myers Squibb, Bayer, Daiichi, Eisai, Fresenius GmbH, Genentech, GlaxoSmithKline, Ipsen, Incyte, Nektar Therapeutics, Nerviano, Novartis, Macrogenics, Medigene, MedImmune, Merck, Millenium, Pfizer, Pierre-Fabre, Roche, Sanofi-Aventis, Sonus, Taiho Oncology, Tesaro, Tigris, Wilex, Wyeth, Gilead; Non-Financial Interests, Leadership Role, President: ABC Global Alliance and ABC Consensus Conference and Guidelines; Non-Financial Interests, Member: ESMO, ESO, EORTC, BCG, IBCSG, SOLTI, ASCO, AACR, EACR, SIS, ASPIC. L. Zuurman, C. Caetano: Other, Institutional, Full or part-time Employment: Bayer CC AG. C. Seitz, S. Parke: Other, Institutional, Full or part-time Employment: Bayer AG. K. Laapas: Other, Institutional, Full or part-time Employment: Bayer Oy. All other authors have declared no conflicts of interest.