[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586587":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":76,"collaborators":79,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":25,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":25,"enrollmentInfo":93,"targetDuration":25,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":40,"whyStopped":25,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Yale University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Fezolinetant","ACTIVE_COMPARATOR","Fezolinetant is an oral medication, and the first neurokinin 3 (NK3) receptor antagonist approved by the FDA in May 2023 for treatment of moderate to severe hot flashes due to menopause. It blocks the activities of the NK3 receptor which is involved in the brain's regulation of body temperature.",[13],"Drug: Fezolinetant",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients will be given placebo tablets to compare to active comparator.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","45 mg tablets, administered orally once daily with or without food, to be taken throughout the entire study phase, i.e. 12 weeks",[9],null,{"type":22,"name":15,"description":23,"armGroupLabels":27,"otherNames":25},[15],[29],{"name":30,"affiliation":5,"role":31},"Maryam Lustberg, MD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":25,"email":37},"Laura Kane","CONTACT","773-369-6904","laura.kane@yale.edu",[39,58],{"facility":5,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-72.92816,41.30815,{"lat":50,"lon":49},[53,57],{"name":54,"role":35,"phone":55,"phoneExt":25,"email":56},"Carl Brown","203-785-4095","carl.brown@yale.edu",{"name":30,"role":31,"phone":25,"phoneExt":25,"email":25},{"facility":59,"status":60,"city":61,"state":62,"zip":63,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"The Ohio State University Comprehensive Cancer Center","NOT_YET_RECRUITING","Columbus","Ohio","43201",{"type":47,"coordinates":65},[66,67],-82.99879,39.96118,{"lat":67,"lon":66},[70,74],{"name":71,"role":35,"phone":72,"phoneExt":25,"email":73},"Cara Dauch","614-814-1393","Cara.Dauch@osumc.edu",{"name":75,"role":31,"phone":25,"phoneExt":25,"email":25},"Sagar Sardesai, MD",{"type":31,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Maryam Lustberg","Professor of Internal Medicine",[80],{"name":81,"class":82},"Astellas Pharma US, Inc.","INDUSTRY","100586587","phase-2-flash-breast-evaluating-the-efficacy-of-fezolinetant-in-reducing-vasomotor-symptoms-in-women-with-breast-cancer-on-endocrine-therapy-100586587",false,"NCT06917313","FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy","A Randomized Phase II Study to Evaluate the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy","Inclusion Criteria:\n\nWomen with diagnosed, histologically confirmed, clinical stage I-III, HR+ invasive breast cancer as defined by ASCO CAP guidelines for whom adjuvant endocrine therapy would be indicated, regardless of HER2 status.\n\nAge 18 years and older.\n\nCurrently on endocrine therapy (tamoxifen or aromatase inhibitors) as part of standard of care treatment for HR+ breast cancer. Endocrine therapy may be administered with or without ovarian suppression and\u002For CDK4\u002F6 inhibitors as permitted in Section 7.1.1. Participants with HER2-positive disease are eligible and may receive concurrent HER2 monoclonal antibody therapy (e.g., trastuzumab or pertuzumab), but not HER2 antibody-drug conjugates (e.g., ado-trastuzumab emtansine T-DM1, or trastuzumab deruxtecan T-DXd).\n\nWilling and able to provide written informed consent\u002Fassent for the trial.\n\nPostmenopausal as defined by spontaneous amenorrhea for at least 12 consecutive months, spontaneous amenorrhea for at least 6 months with biochemical criteria or menopause (FSH \\> 40 IU\u002FL), or bilateral oophorectomy for at least 6 weeks before the screening visit, or if premenopausal chemically suppressed by GnRH agonist therapy with ultrasensitive estradiol level \\\u003C10.\n\nOn endocrine therapy for a minimum of 3 months and has planned duration of 12 weeks left in the treatment regimen. Participants receiving a CDK4\u002F6 inhibitor must have been on treatment for at least 4 weeks prior to enrollment.\n\nExperiencing an average of seven or more moderate to severe hot flashes per day over a 7-day period as documented by Symptom Diary during the Screening Period and seeking treatment or relief for VMS.\n\nAble to swallow oral formulation of the study agent.\n\nExclusion Criteria:\n\nParticipants who have a diagnosis of stage IV metastatic disease.\n\nReceiving any other cancer treatment other than endocrine therapy. This includes chemotherapy, targeted therapies, and immunotherapy.\n\nReceiving cytochrome CYP1A2 inhibitors.\n\nParticipants who have initiated, discontinued, or had a dose adjustment of treatment for vasomotor symptoms (prescription, over the counter, or herbal) within 28 days prior to screening.\n\nPregnant or lactating patients.\n\nKnown cirrhosis or active liver disease, jaundice, or elevated liver aminotransferases (ALT or AST) \\>2x ULN, or elevated total bilirubin, OR elevated direct bilirubin, or elevated INR, or elevated alkaline phosphatase \\>2x ULN.\n\nCreatinine \\> 1.5 times upper limit of normal; or estimated GFR ≤ 30 mL\u002Fmin per 1.73 m2 at screening.\n\nJudgement by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.",true,"FEMALE","18 Years",{"count":94,"type":95},92,"ESTIMATED","INTERVENTIONAL",[98],"PHASE2","This is a phase II, randomized, double-blinded, placebo-controlled trial designed to evaluate the efficacy of fezolinetant (45 mg a day) vs. placebo in reducing moderate to severe vasomotor symptoms (VMS) in breast cancer survivors on endocrine therapy (tamoxifen, aromatase inhibitors). The trial will proceed in a single stage, and the total of 92 participants will be randomized in 1:1 fashion to fezolinetant or placebo arm respectively.",[101],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[103,104,105,106],"adjuvant endocrine therapy","vasomotor symptoms","tamoxifen","aromatase","2026-05-30",{"date":109,"type":110},"2026-06-02","ACTUAL",{"date":112,"type":110},"2025-12-05",{"date":114,"type":95},"2028-03",{"name":5,"class":6},2]