A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer
- Conditions
- Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast CancerHot Flashes
- Registration Number
- NCT05587296
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Females aged 18 to 70 years of age inclusive, at the time of signing the informed<br> consent.<br><br> - Women experiencing vasomotor symptoms (VMS) caused by adjuvant endocrine therapy<br> that they are expected to use for the duration of the study<br><br> - Tamoxifen with or without the use of gonadotropin-releasing hormone (GnRH)<br> analogues or<br><br> - Aromatase inhibitors with or without the use of GnRH analogues<br><br> - Women must have<br><br> - a personal history of hormone-receptor positive breast cancer or<br><br> - a high risk for developing breast cancer.<br><br> - Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during<br> the two weeks preceding baseline visit, and participant has recorded at least 35<br> moderate to severe hot flash (HF) (including night-time HF) over the last 7 days<br> that the HFDD was completed (assessed at the Baseline Visit).<br><br> - Contraceptive use by [women except for post-menopausal women or Women of Non<br> childbearing potential (WONCBP)] should be consistent with local regulations<br> regarding the methods of contraception for those participating in clinical studies.<br><br>Exclusion Criteria:<br><br> - Initial diagnosis of metastatic hormone-receptor positive breast cancer (stage IV)<br> or recurrence under adjuvant endocrine therapy of hormone-receptor positive breast<br> cancer.<br><br> - Current or history (except complete remission for 5 years or more prior to signing<br> informed consent) of any malignancy, except for hormone-receptor positive breast<br> cancer (Stage 0-III), basal and squamous cell skin tumors.<br><br> - Surgery or non-surgical (e.g., chemotherapy, radiotherapy, immunotherapy) treatment<br> for breast cancer within the last 3 months prior to signing informed consent (except<br> use of tamoxifen, aromatase inhibitors, GnRH analogues).<br><br> - Any clinically significant prior or ongoing history of arrhythmias, heart block and<br> QT prolongation either determined through clinical history or on electrocardiogram<br> (ECG) evaluation.<br><br> - Any active ongoing condition that could cause difficulty in interpreting VMS such<br> as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome.<br><br> - Any unexplained vaginal bleeding.<br><br> - Mammogram with clinically relevant malignant or suspicious findings that will<br> require surgery, radiotherapy or chemotherapy as per local guidelines (mammogram<br> should not be older than 12 months prior to signing informed consent). If a<br> mammogram is not possible after partial mastectomy an ultrasound could be performed<br> instead.<br><br> - Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial<br> cancer diagnosed based on endometrial biopsy during screening.<br><br> - Current arterial or venous vascular event (e.g., Myocardial infarction (MI),<br> Transient ischemic attack (TIA), stroke, deep vein thrombosis (DVT), i.e., within<br> the last 6 months prior to signing informed consent.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]);Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD)
- Secondary Outcome Measures
Name Time Method Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD).;Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD);Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD);Mean change in frequency of moderate to severe HF from baseline over time (assessed by HFDD);Mean change in patient-reported outcomes measurement information system sleep disturbance short form 8b (PROMIS SD SF 8b) total score from baseline to Week 12;Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12