Nctid:
NCT06231693
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D001943", "term"=>"Breast Neoplasms"}], "ancestors"=>[{"id"=>"D009371", "term"=>"Neoplasms by Site"}, {"id"=>"D009369", "term"=>"Neoplasms"}, {"id"=>"D001941", "term"=>"Breast Diseases"}, {"id"=>"D012871", "term"=>"Skin Diseases"}], "browseLeaves"=>[{"id"=>"M5220", "name"=>"Breast Neoplasms", "asFound"=>"Breast Cancer", "relevance"=>"HIGH"}, {"id"=>"M5218", "name"=>"Breast Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000068878", "term"=>"Trastuzumab"}, {"id"=>"C000614160", "term"=>"Trastuzumab deruxtecan"}], "ancestors"=>[{"id"=>"D000074322", "term"=>"Antineoplastic Agents, Immunological"}, {"id"=>"D000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D018796", "term"=>"Immunoconjugates"}, {"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M325", "name"=>"Trastuzumab", "asFound"=>"HIV", "relevance"=>"HIGH"}, {"id"=>"M233243", "name"=>"Trastuzumab deruxtecan", "asFound"=>"Absorbable", "relevance"=>"HIGH"}, {"id"=>"M1346", "name"=>"Antineoplastic Agents, Immunological", "relevance"=>"LOW"}, {"id"=>"M20855", "name"=>"Immunoconjugates", "relevance"=>"LOW"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"OTHER", "observationalModel"=>"CASE_ONLY"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>2}, "patientRegistry"=>false}, "statusModule"=>{"whyStopped"=>"The study was stopped due to a realignment of strategic priorities", "overallStatus"=>"TERMINATED", "startDateStruct"=>{"date"=>"2023-12-04", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-03-26", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-30", "studyFirstSubmitDate"=>"2024-01-11", "studyFirstSubmitQcDate"=>"2024-01-26", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-26", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Time to Next Treatment", "timeFrame"=>"Through study completion, an average of 1 year"}], "secondaryOutcomes"=>[{"measure"=>"Response Rate", "timeFrame"=>"Through study completion, an average of 18 months"}, {"measure"=>"Real World Progression Free Survival", "timeFrame"=>"Through study completion, an average of 18 months"}, {"measure"=>"Real World Overall Survival", "timeFrame"=>"Through study completion, an average of 18 months"}, {"measure"=>"Epidemiological Features", "timeFrame"=>"Through study completion, an average of 18 months", "description"=>"Age, comorbidities, somatic mutations, pattern of HER2 testing."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>true, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Breast Cancer"]}, "descriptionModule"=>{"briefSummary"=>"A national, multicenter, retrospective, observational study (Real-World Evidence-RWE) aimed to assess the efficacy of Trastuzumab-deruxtecan (T-DXd) in patients with triple-negative (RE\\<10%) metastatic HER2-Low breast cancer.", "detailedDescription"=>"Data from study DESTINY-04 have established T-DXd as the standard second-line treatment for HER2-Low breast tumors. In that study, about 90% of the population had estrogen-positive receptor (ER+) tumors, under-representing negative ER population. The investigators propose to assess T-DXd efficacy in HER2-Low/ER ≤10% patients in Brazilian population by means of a RWE analysis. Endpoints will be assessment of time to the next treatment, objective response rate, and real-world progression-free survival and real-world overall survival."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Adult patients, with metastatic HER2-Low/ER ≤10% breast tumors, from Brazilian population, who were given TDXd as per usual prescription from their physician", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged above 18 years old;\n* Have advanced, hormone receptor negative (ER ≤10%), HER2-Low (1+ or 2+/FISH negative) breast cancer;\n* Have been treated with at least one trastuzumab-deruxtecan dose for advanced disease (incurable) as a second or later line;\n* Do not have active CNS metastatic lesions, characterized as stable, asymptomatic lesions and with no targeted treatment for at least 6 months.\n\nExclusion Criteria:\n\n* Have been previously treated with trastuzumab-deruxtecan (neoadjuvant, adjuvant, other neoplasms);\n* Have other active neoplasms (except from non-melanoma skin tumors);\n* Have serious or active non-oncology lung diseases;\n* Have other primary and concurrent breast tumor with differing receptor profiles."}, "identificationModule"=>{"nctId"=>"NCT06231693", "briefTitle"=>"Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"AstraZeneca"}, "officialTitle"=>"Trastuzumab-deruxtecan in Patients With Triple-negative Metastatic HER2-Low Breast Cancer: Real-world Experience in Brazil", "orgStudyIdInfo"=>{"id"=>"D9673R00036"}, "secondaryIdInfos"=>[{"id"=>"74911423.1.1001.0071", "type"=>"OTHER", "domain"=>"Hospital Israelita Albert Einstein"}]}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Trastuzumab-deruxtecan", "interventionNames"=>["Drug: Trastuzumab deruxtecan"]}], "interventions"=>[{"name"=>"Trastuzumab deruxtecan", "type"=>"DRUG", "description"=>"Patients with RE\\<10% and HER2-Low breast cancer that have received Trastuzumab-deruxtecan in the metastatic setting", "armGroupLabels"=>["Trastuzumab-deruxtecan"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Porto Alegre", "state"=>"Rio Grande Do Sul", "country"=>"Brazil", "facility"=>"Research Site", "geoPoint"=>{"lat"=>-30.03306, "lon"=>-51.23}}, {"city"=>"São Paulo", "country"=>"Brazil", "facility"=>"Research Site", "geoPoint"=>{"lat"=>-23.5475, "lon"=>-46.63611}}], "overallOfficials"=>[{"name"=>"Italo Fernandes, MD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Hospital Israelita Albert Einstein"}]}, "ipdSharingStatementModule"=>{"url"=>"https://astrazenecagroup-dt.pharmacm.com/DT/Home", "infoTypes"=>["STUDY_PROTOCOL", "SAP"], "timeFrame"=>"AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.", "ipdSharing"=>"YES", "description"=>"Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\n\"Yes\", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.", "accessCriteria"=>"When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"AstraZeneca", "class"=>"INDUSTRY"}, "collaborators"=>[{"name"=>"Hospital Israelita Albert Einstein", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
