OASIS-4 study

Overall Assessment of efficacy and Safety of elinzanetant In patients with vasomotor Symptoms in women with, or at high risk for developing hormone-receptor positive breast cancer

Background

Hot flashes, also known as vasomotor symptoms (VMS), are not just related to menopause; they are also a common side effect for women undergoing adjuvant endocrine therapy, such as tamoxifen or aromatase inhibitors, to treat hormone receptor-positive breast cancer. These therapies, which women typically take for 5 to 10 years, are crucial in reducing the risk of cancer returning. However, they often cause VMS, which can significantly impact a woman’s quality of life and adherence to treatment.

Tamoxifen is used for both pre- and post-menopausal women, but in post-menopausal women, aromatase inhibitors are often preferred due to their effectiveness. Ovarian function suppression may also be combined with these therapies for added benefit.

While these treatments are essential for preventing cancer recurrence, they come with side effects like hot flashes, for which effective treatment options are limited. Hormone-based treatments for VMS are not suitable for women with hormone receptor-positive breast cancer, and non-hormonal options often lack strong evidence of effectiveness.

Elinzanetant, a new drug under study, works differently by targeting specific receptors in the brain involved in temperature regulation, offering hope for managing VMS in these patients.

About this scientific research

This is an ongoing phase 3 study designed to evaluate the efficacy and safety of elinzanetant in the treatment of vasomotor symptoms (VMS) induced by adjuvant endocrine therapy in women who have, or are at high risk of developing, hormone receptor-positive breast cancer. The study aims to provide critical insights into how elinzanetant can alleviate VMS, which are common and often debilitating side effects of endocrine therapy. The trial will continue to monitor and assess the long-term outcomes to ensure comprehensive data on both the therapeutic benefits and potential risks associated with elinzanetant in this patient population.