Patients with breast cancer can enroll on a clinical trial analyzing elinzanetant for endocrine therapy-related hot flashes.
An expanded clinical trial called OASIS 4 will investigate a new drug, elinzanetant, in treating vasomotor symptoms (hot flashes) in women with breast cancer undergoing endocrine therapy.
According to Bayer, the manufacturer of elinzantant, hot flashes affect up to 80% of women who are undergoing menopause and can have negative effects of quality of life. When treatments such as endocrine therapy may be contributing to this side effect, patients may be less likely to take their drugs as prescribed, Bayer said in a press release.
Endocrine therapy is a common treatment method for patients with hormone-receptor—positive disease. The treatment’s goal is to reduce hormone levels, which can result in feelings of night sweats, hot flashes and vaginal dryness.
“For women treated with endocrine therapy for breast cancer — potentially for numerous years — vasomotor symptoms can intensively affect their quality of life and treatment continuation, which in turn might impact the effectiveness of their cancer therapy and hence their survival”, said Dr. Christian Rommel, member of the executive committee of Bayer AG’s Pharmaceutical Division and global head of Research and Development, in the release.
OASIS 4 will be an added component to the currently ongoing phase 3 trial of elinzanetant in menopausal women without breast cancer.
Researchers plan on enrolling approximately 400 patients in the global. Some will be randomly assigned to receive 120 mg daily of elinzanetant, while others will receive a placebo.
The main goal of the study is to determine an average change in the frequency of moderate to severe hot flashes from the start of treatment until weeks 4 and 12.
Researchers also plan to analyze the average change in severity of moderate to severe hot flashes from baseline to weeks 4 and 12; average change in frequency of moderate to severe hot flashes from baseline to week 1; change in frequency of moderate to severe hot flashes over time; average change in sleep disturbances over 12 weeks; and average change in menopause-related quality of life over 12 weeks, according to the study’ listing on clinicaltrials.gov.
To be eligible for the trial, patients must be diagnosed with hormone-receptor—positive breast cancer or be at risk for developing the disease. Those with cancer must be taking tamoxifen or an aromatase inhibitor and are expected to stay on their therapy throughout the trial.
Researchers are still recruiting participants for OASIS 4, and study data is expected to come out in December 2024.
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