[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100438230":3},{"organization":4,"armGroups":7,"interventions":38,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":100,"collaborators":103,"id":116,"slug":73,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":73,"eligibilityCriteria":121,"healthyVolunteers":117,"sex":122,"minAge":123,"maxAge":73,"enrollmentInfo":124,"targetDuration":73,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":78,"whyStopped":73,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Dana-Farber Cancer Institute","OTHER",[8,15,20,25,29,34],{"label":9,"type":10,"description":11,"interventionNames":12},"ERIBULIN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)","EXPERIMENTAL","Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with Eribulin.\n\nStudy cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.",[13,14],"Device: Paxman Scalp Cooling System","Drug: Eribulin",{"label":16,"type":17,"description":18,"interventionNames":19},"ERIBULIN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)","ACTIVE_COMPARATOR","Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with Eribulin.\n\nStudy cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.",[14],{"label":21,"type":10,"description":22,"interventionNames":23},"SACITUZUMAB GOVITECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)","Participants will use Paxman Scalp Cooling System (PSCS) on days 1 and 21 of each of their standard of care (SOC) treatment cycles with SACITUZUMAB GOVITECAN.\n\nStudy cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.",[13,24],"Drug: Sacituzumab govitecan",{"label":26,"type":17,"description":27,"interventionNames":28},"SACITUZUMAB GOVITECAN WITHOUT PAXMAN SCALP COOLING SYSTEM (PSCS)","Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with SACITUZUMAB GOVITECAN.\n\nStudy cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.",[24],{"label":30,"type":10,"description":31,"interventionNames":32},"TRASTUZUMAB DERUXTECAN WITH PAXMAN SCALP COOLING SYSTEM (PSCS)","Participants will use Paxman Scalp Cooling System (PSCS) on days 1, 8 and 21 of each of their standard of care (SOC) treatment cycles with TRASTUZUMAB DERUXTECAN.\n\nStudy cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.",[13,33],"Drug: Trastuzumab deruxtecan",{"label":35,"type":17,"description":36,"interventionNames":37},"TRASTUZUMAB DERUXTECAN WITHOUT PAXMAN SCALP COOLING SYSTEM","Participants will not use Paxman Scalp Cooling System (PSCS) during their standard of care (SOC) treatment with TRASTUZUMAB DERUXTECAN.\n\nStudy cyle is 21 days with total number of cycles based on discretion of treating provider up to 2 years.",[33],[39,46,53,59],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"DEVICE","Paxman Scalp Cooling System","Cap attached to coolant lines connected to a refrigeration unit placed on scalp",[9,21,30],[45],"Scalp Cooling Cap",{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","Eribulin","Intravenous Infusion",[9,16],[52],"Halaven",{"type":47,"name":54,"description":49,"armGroupLabels":55,"otherNames":56},"Sacituzumab govitecan",[21,26],[57,58],"Trodelvy","IMMU-132",{"type":47,"name":60,"description":49,"armGroupLabels":61,"otherNames":62},"Trastuzumab deruxtecan",[30,35],[63,64],"Enhertu","DS-8201a",[66],{"name":67,"affiliation":5,"role":68},"Elahe Salehi, DNP, ANP-BC","PRINCIPAL_INVESTIGATOR",[70],{"name":67,"role":71,"phone":72,"phoneExt":73,"email":74},"CONTACT","617-632-3800",null,"elahe_salehi@dfci.harvard.edu",[76,92],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Brigham and Women's Hospital","RECRUITING","Boston","Massachusetts","02115","United States",{"type":84,"coordinates":85},"Point",[86,87],-71.05977,42.35843,{"lat":87,"lon":86},[90,91],{"name":67,"role":71,"phone":72,"phoneExt":73,"email":74},{"name":67,"role":68,"phone":73,"phoneExt":73,"email":73},{"facility":93,"status":78,"city":79,"state":80,"zip":81,"country":82,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Dana Farber Cancer Institute",{"type":84,"coordinates":95},[86,87],{"lat":87,"lon":86},[98,99],{"name":67,"role":71,"phone":72,"phoneExt":73,"email":74},{"name":67,"role":68,"phone":73,"phoneExt":73,"email":73},{"type":68,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":73,"oldOrganization":73},"Elahe Salehi, NP","Principal Investigator",[104,107,110,112,114],{"name":105,"class":106},"Paxman Coolers Limited","UNKNOWN",{"name":108,"class":109},"AstraZeneca","INDUSTRY",{"name":111,"class":109},"Eisai Inc.",{"name":113,"class":109},"Daiichi Sankyo",{"name":115,"class":109},"Gilead Sciences","100438230",false,"NCT04986579","Scalp Cooling in MBC","Assessing the Impact of Scalp Cooling in With Metastatic Breast Cancer","Inclusion Criteria:\n\n* Men and women with a diagnosis of metastatic invasive breast cancer with a ECOG PS≤2\n* Participant is ≥ 18 years old.\n* Hair present at baseline.\n* One of the following full dose chemotherapy regimens must be planned for at least 4 cycles:\n\n  * Sacituzumab govitecan (IMMU-132) 10 mg\u002Fkg administered intravenously on days 1 and 8 of each 21-day cycle\n  * Trastuzumab deruxtecan 5.4 mg\u002Fkg administered intravenously once every 3 weeks\n  * Eribulin 1.4 mg\u002Fm2 administered intravenously on days 1 and 8 of each 21-day cycle\n* The Paxman Scalp Cooling System must be initiated with the first dose of therapy in participants that elect to participate in the scalp cooling group.\n\nExclusion Criteria:\n\n* Known hematological malignancies (i.e. leukemia or lymphoma)\n* Known scalp metastases.\n* Baseline alopecia (defined CTCAE 5.0 grade \\> 0, see Appendix B)\n* Subjects with cold agglutinin disease or cold urticaria.\n* Subjects who are scheduled for bone marrow ablation chemotherapy.\n* Personal history of migraines, cluster or tension headaches as defined as actual medical diagnosis by a physician and\u002F or prescribed medications. If personal history of migraines was related to a past medical problem that is now resolved, the subject may go on study at the discretion of the Principal Investigator.\n* Subjects who have lichen planus or lupus.\n* Participants who are receiving any additional anti-cancer agents","ALL","18 Years",{"count":125,"type":126},120,"ESTIMATED","INTERVENTIONAL",[129],"PHASE2","This research is being done to compare rates of hair loss of people with metastatic breast who use scalp cooling versus those who do not use scalp cooling after receiving standard of care treatment with either sacituzumab govitecan, trastuzumab deruxtecan, or eribulin.\n\nThe name of the study intervention involved in this study is:\n\n* Paxman Scalp Cooling System",[132,133],"Metastatic Breast Cancer","Chemotherapy-induced Alopecia",[132,133],"2026-06-16",{"date":137,"type":138},"2026-06-18","ACTUAL",{"date":140,"type":138},"2021-10-07",{"date":142,"type":126},"2030-06-01",{"name":5,"class":6},2]