A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy
- Conditions
- Hot Flashes
- Registration Number
- NCT06440967
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 540
Inclusion Criteria:<br><br> - Participant has a personal history of stage 0-3 hormone receptor positive (HR+),<br> either human epidermal growth factor receptor (HER)-2+ or HER-2- breast cancer;<br> appropriate documentation includes a written or electronic report.<br><br> - Participant must be receiving stable maintenance adjuvant endocrine therapy<br> (tamoxifen 20 mg daily or aromatase inhibitors, such as anastrozole, letrozole and<br> exemestane) with or without gonadotropin-releasing hormone (GnRH)<br> agonists/antagonists for a minimum of 4 months and be planning to continue on<br> adjuvant endocrine therapy for the duration of the trial without change to therapy,<br> brand or dose. Add-on therapies for breast cancer adjuvant treatment (e.g., cyclin<br> dependent kinase-4 (CDK4) inhibitors) are allowed.<br><br> - Participant has a minimum average of 7 moderate to severe hot flashes (HFs)<br> (vasomotor symptoms (VMS)) per day as recorded in the electronic daily diary (data<br> must be available for at least 7 of the last 10 days prior to randomization).<br><br> - Has an European Cooperative Oncology Group (ECOG) score 0 or 1.<br><br> - Has at least 12-month life expectation.<br><br> - Participant is born female.<br><br> - Female participant: Is not pregnant and at least 1 of the following conditions<br> apply:<br><br> - Not a woman of childbearing potential (WOCBP)<br><br> - WOCBP who has a negative urine or serum pregnancy test at screening and day 1<br> and agrees to follow the contraceptive guidance from the time of informed<br> consent through at least 30 days after final study intervention administration.<br><br> - Female participant: Must not be breastfeeding or lactating starting at screening and<br> throughout the investigational period and for 30 days after final study intervention<br> administration.<br><br> - Female participant: Must not donate ova starting at first administration of study<br> intervention and throughout the investigational period and for 30 days after final<br> study intervention administration.<br><br> - Participant agrees not to participate in another interventional study while<br> participating in the present study.<br><br> - Participant has a body mass index (BMI) range of 18 kg/m2 to 38 kg/m2 inclusive at<br> screening.<br><br> - Participant's condition is stable as determined on the basis of medical history and<br> general physical examination (including a bimanual clinical pelvic examination<br> devoid of relevant clinical findings performed at the screening visit), hematology<br> and biochemistry parameters, pulse rate and/or blood pressure and electrocardiogram<br> (ECG) (or showing no clinically relevant deviations obtained within the last 3<br> months or at screening).<br><br> - Participant has no new clinically significant findings on breast examination or from<br> imaging (mammogram or breast ultrasound). Results indicate that the participant is a<br> good candidate for the study. Appropriate documentation includes a written or<br> electronic report. In case of double mastectomy, imaging is not needed.<br><br> - Participant has no clinically significant findings on a transvaginal ultrasound<br> (TVU) result obtained within the last 3 months or at screening. Results indicate<br> that the participant is a good candidate for the study. This is not required for<br> participants who have had a partial (supra-cervical) or total hysterectomy.<br><br> - Participant has a negative serology panel (including hepatitis B surface antigen<br> (HBsAg), hepatitis C virus (HCV) antibody and human immunodeficiency virus (HIV)<br> antibody screens).<br><br>Exclusion Criteria:<br><br> - Participant has diagnosis of metastatic breast cancer (stage 4).<br><br> - Participant has current or history (except complete remission for 5 years or more<br> prior to signing informed consent) of any malignancy except for HR+ breast cancer<br> (stage 0 to 3) or basal cell carcinoma.<br><br> - Participant has had surgery or non-surgical (chemotherapy or radiotherapy) treatment<br> for breast cancer within the last 3 months prior to signing informed consent.<br><br> - Participant has active liver disease, jaundice, or elevated liver aminotransferases<br> (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)), elevated total<br> bilirubin (TBL) or direct bilirubin (DBL), elevated international normalized ratio<br> (INR) or elevated alkaline phosphatase (ALP) at screening. A participant with mildly<br> elevated ALT or AST up to < 2 × upper limit of normal (ULN) can be enrolled if TBL<br> and DBL are normal. Participant with mildly elevated ALP (up to < 1.5 × ULN) can be<br> enrolled if cholestatic liver disease is excluded and no cause other than fatty<br> liver is diagnosed. Participant with Gilbert's syndrome with elevated TBL may be<br> enrolled as long as DBL, hemoglobin and reticulocytes are normal.<br><br> - Participant has creatinine > 1.5 x ULN; or estimated glomerular filtration rate<br> (eGFR) using the Modification of Diet in Renal Disease formula < 30 mL/min/1.73 m2<br> at the screening visit.<br><br> - Participant has a history of endometrial hyperplasia or uterine/endometrial cancer.<br><br> - Participant has a medical condition or chronic disease (including history of<br> neurological [including cognitive], hepatic, renal, cardiovascular,<br> gastrointestinal, pulmonary [e.g., moderate asthma], endocrine, or gynecological<br> disease) or malignancy that could confound interpretation of the study outcome.<br><br> - Participant uses a prohibited therapy (menopause hormone therapy (MHT),<br> estradiol-containing hormonal contraceptive progestin and progesterone-only<br> medicines, any treatment for VMS [prescription medications, over-the-counter, or<br> herbal] or CYP1A2 (cytochrome P450) inhibitors) or is not willing to wash out such<br> drugs; in addition, medications that are contraindicated due to underlying breast<br> cancer diagnosis and the adjuvant endocrine therapy.<br><br> - Participant has a known substance abuse or alcohol addiction within 6 months of<br> screening.<br><br> - Participant has received any investigational therapy within 90 days or 5 half-lives,<br> whichever is longer, prior to screening.<br><br> - Participant has any condition, which makes the participant unsuitable for study<br> participation.<br><br> - Participant has a known or suspected hypersensitivity to fezolinetant, the adjuvant<br> endocrine therapy being used, or any components of the formulations used.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from Baseline to Week 4 in the frequency of moderate to severe VMS;Mean change from Baseline to Week 12 in the frequency of moderate to severe VMS;Mean change from Baseline to Week 4 in the severity of moderate to severe VMS;Mean change from Baseline to Week 12 in the severity of moderate to severe VMS
- Secondary Outcome Measures
Name Time Method