Vasomotor symptoms caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer MedDRA version: 20.0 Level: LLT Classification code 10022457 Term: Instability vasomotor System Organ Class: 100000004852 MedDRA version: 21.0 Level: LLT Classification code 10020407 Term: Hot flashes System Organ Class: 100000004866
Conditions
Sponsors
Bayer Consumer Care AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Females aged 18 to 70 years of age inclusive, at the time of signing the informed consent. 2.Women experiencing vasomotor symptoms (VMS) caused by adjuvant endocrine therapy that they are expected to use for the duration of the study a. Tamoxifen (maximum daily dose of 20 mg) with or without the use of gonadotropin-releasing hormone (GnRH) analogues or b. Aromatase inhibitors with or without the use of GnRH analogues 3. Women must have a. a personal history of hormone-receptor positive breast cancer or b. a high risk for developing breast cancer. 4. Participant has completed Hot Flash Daily Diary (HFDD) for at least 11 days during the two weeks preceding baseline visit, and participant has recorded at least 35 moderate to severe hot flash (HF) (including night-time HF) over the last 7 days that the HFDD was completed (assessed at the Baseline Visit). 5. Contraceptive use by [women except for post-menopausal women or Women of Non childbearing potential (WONCBP)] should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 305 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1.Initial diagnosis of metastatic hormone-receptor positive breast cancer (stage IV) or recurrence under adjuvant endocrine therapy of hormone-receptor positive breast cancer. 2.Current or history (except complete remission for 5 years or more prior to signing informed consent) of any malignancy, except for hormone-receptor positive breast cancer (Stage 0-III), basal and squamous cell skin tumors. 3.Surgery or non-surgical (e.g., chemotherapy, radiotherapy, immunotherapy) treatment for breast cancer within the last 3 months prior to signing informed consent (except use of tamoxifen, aromatase inhibitors, GnRH analogues). 4. Any clinically significant prior or ongoing history of arrhythmias, heart block and QT prolongation either determined through clinical history or on electrocardiogram (ECG) evaluation. 5.Any active ongoing condition that could cause difficulty in interpreting VMS such as: infection that could cause pyrexia, pheochromocytoma, carcinoid syndrome. 6.Any unexplained vaginal bleeding. 7.Mammogram with clinically relevant malignant or suspicious findings that will require surgery, radiotherapy or chemotherapy as per local guidelines (mammogram should not be older than 12 months prior to signing informed consent). If a mammogram is not possible after partial mastectomy an ultrasound could be performed instead. 8.Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy during screening. 9.Current arterial or venous vascular event (e.g., Myocardial infarction (MI), Transient ischemic attack (TIA), stroke, deep vein thrombosis (DVT), i.e., within the last 6 months prior to signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of elinzanetant for the treatment of vasomotor symptoms (VMS) caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone receptor positive breast cancer;Secondary Objective: 1. To evaluate the onset of efficacy of elinzanetant for the treatment of VMS caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone-receptor positive breast cancer. 2. To evaluate the efficacy of elinzanetant in women with, or at high risk for developing hormone receptor positive breast cancer on: sleep quality and menopause related quality of life. 3. To evaluate the safety of elinzanetant for the treatment of VMS caused by adjuvant endocrine therapy in women with, or at high risk for developing hormone receptor positive breast cancer.;Primary end point(s): 1. Mean change in frequency of moderate to severe hot flash (HF) from baseline to Week 4 (assessed by hot flash daily diary [HFDD]). 2. Mean change in frequency of moderate to severe HF from baseline to Week 12 (assessed by HFDD).;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 4. 2. Baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Mean change in severity of moderate to severe HF from baseline to Week 4 (assessed by HFDD). 2. Mean change in severity of moderate to severe HF from baseline to Week 12 (assessed by HFDD). 3. Mean change in frequency of moderate to severe HF from baseline to Week 1 (assessed by HFDD). 4. Mean change in frequency of moderate to severe HF from baseline over time. 5. 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. 6. Mean change in menopause specific quality of life scale (MENQOL) total score from baseline to Week 12.;Timepoint(s) of evaluation of this end point: 1. Baseline to Week 4. 2. Baseline to Week 12. 3. Baseline to Week 1. 4. Baseline to week 56. 5. Baseline to Week 12. 6. Baseline to Week 12. | — |
Countries
Belgium, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Portugal, Russian Federation, Spain, United Kingdom
Contacts
Public ContactBayer Clinical Trials Contact
Bayer AG
Outcome results
None listed