OASIS-4
Trial question
What is the effect of elinzanetant on vasomotor symptoms associated with endocrine therapy in patients with HR+ breast cancer?
Study design
Multi-center
Double blinded
RCT
Population
474 female patients.
Inclusion criteria: women, aged 18-70 years, with HR+ breast cancer receiving endocrine therapy.
Key exclusion criteria: initial diagnosis of metastatic HR+ breast cancer or a recurrence of HR+ breast cancer while receiving endocrine therapy; surgical or nonsurgical treatment for breast cancer within 3 months before signing informed consent; surgery, chemotherapy, radiotherapy, or immunotherapy that was scheduled to take place during the trial.
Interventions
N=316 elinzanetant (120 mg once daily for 52 weeks).
N=158 placebo (matching placebo once daily for 12 weeks followed by elinzanetant 120 mg once daily for 40 weeks).
Primary outcome
Least-squares mean reduction in daily frequency of moderate-to-severe vasomotor symptoms at week 4
6.5
3
6.5 episodes
4.9 episodes
3.3 episodes
1.6 episodes
0.0 episodes
Elinzanetant
Placebo
Significant
increase ▲
Significantly greater reduction in least-squares mean daily frequency of moderate-to-severe vasomotor symptoms at week 4 (6.5 episodes vs. 3 episodes; MD 3.5, 95% CI 2.6 to 4.4).
Secondary outcomes
Significantly greater reduction in least-squares mean daily frequency of moderate-to-severe vasomotor symptoms at week 12 (7.8 episodes vs. 4.2 episodes; MD 3.4, 95% CI 2.5 to 4.2).
Significant increase in least-squares mean reduction Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score at week 12 (10.6 points vs. 4.1 points; MD 6.1, 95% CI 4.8 to 7.5).
Significantly greater reduction in least-squares mean Menopause-Specific QoL questionnaire total score at week 12 (1.3 points vs. 0.5 points; MD 0.7, 95% CI 0.5 to 0.9).
Safety outcomes
No significant difference in adverse events during weeks 1 through 12.
Conclusion
In women, aged 18-70 years, with HR+ breast cancer receiving endocrine therapy, elinzanetant was superior to placebo with respect to a least-squares mean reduction in daily frequency of moderate-to-severe vasomotor symptoms at week 4.
Reference
Fatima Cardoso, Susanne Parke, Donal J Brennan et al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med. 2025 Jun 2. Online ahead of print.
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