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Check out this exciting research study on elinzanetant as a non-hormonal treatment for vasomotor signs caused by endocrine treatment in breast cancer patients. Elinzanetant is an innovative, non-hormonal substance currently in development for the treatment of vasomotor signs during menopause.
Huge news coming from Berlin today! Bayer, a global leader in women’s healthcare, has expanded the Phase III clinical development program OASIS by initiating OASIS 4. This is a Phase III research study focusing on breast cancer patients and women with a high risk of breast cancer who are experiencing vasomotor signs caused by endocrine treatment.
Breast cancer is the most common cancer in women worldwide, with 2.3 million new cases in 2020. Almost 70% of breast cancers are hormone-receptor positive. The majority of these patients are undergoing adjuvant endocrine treatment for at least 5 years to reduce the recurrence of breast cancer. Endocrine treatment can also be used as primary prevention in women at high risk for developing breast cancer. Vasomotor signs (VMS), also known as hot flashes, are a known adverse reaction of endocrine treatment, significantly impacting quality of life and treatment compliance. There is a critical need for an effective non-hormonal treatment for VMS caused by endocrine treatment in breast cancer patients and women at high risk for developing breast cancer, as no treatment options are currently available.
“Vasomotor signs can have a significant impact on the quality of life and treatment compliance of women undergoing endocrine treatment for breast cancer. By adding OASIS 4 to our Phase III program with elinzanetant, we aim to assist patients experiencing these symptoms and improve their overall quality of life,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development.
The OASIS 4 Phase III study aims to randomize approximately 400 patients at about 95 centers in 15 countries and will evaluate the effectiveness and safety of elinzanetant 120 mg daily in women at high risk for breast cancer and breast cancer patients with vasomotor signs caused by endocrine treatment.
In August 2021, the OASIS Phase III clinical development program began evaluating the effectiveness and safety of elinzanetant 120 mg daily in menopausal women with vasomotor signs.
About Vasomotor Symptoms
Vasomotor signs (VMS), also known as hot flashes, are a result of hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons due to withdrawal of estradiol, which can result from the progressive decline of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine treatment.
VMS (hot flashes) are reported by up to 80% of women at some point during the menopausal transition and are the leading cause for seeking medical attention during this stage of a woman’s life. » …
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