Nctid:
NCT06223698
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001943", "term"=>"Breast Neoplasms"}], "ancestors"=>[{"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000001941", "term"=>"Breast Diseases"}, {"id"=>"D000012871", "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"=>"D000013629", "term"=>"Tamoxifen"}, {"id"=>"D000077289", "term"=>"Letrozole"}, {"id"=>"D000077384", "term"=>"Anastrozole"}, {"id"=>"C000056516", "term"=>"Exemestane"}], "ancestors"=>[{"id"=>"D000000970", "term"=>"Antineoplastic Agents"}, {"id"=>"D000047072", "term"=>"Aromatase Inhibitors"}, {"id"=>"D000065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D000004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000004965", "term"=>"Estrogen Antagonists"}, {"id"=>"D000006727", "term"=>"Hormone Antagonists"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000018931", "term"=>"Antineoplastic Agents, Hormonal"}, {"id"=>"D000020845", "term"=>"Selective Estrogen Receptor Modulators"}, {"id"=>"D000020847", "term"=>"Estrogen Receptor Modulators"}, {"id"=>"D000050071", "term"=>"Bone Density Conservation Agents"}], "browseLeaves"=>[{"id"=>"M1743", "name"=>"Letrozole", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M25769", "name"=>"Aromatase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M16403", "name"=>"Tamoxifen", "asFound"=>"Project", "relevance"=>"HIGH"}, {"id"=>"M1781", "name"=>"Anastrozole", "asFound"=>"Physiological", "relevance"=>"HIGH"}, {"id"=>"M247237", "name"=>"Exemestane", "asFound"=>"Green", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M8116", "name"=>"Estrogens", "relevance"=>"LOW"}, {"id"=>"M8114", "name"=>"Estrogen Antagonists", "relevance"=>"LOW"}, {"id"=>"M30483", "name"=>"Estrogen Receptor Antagonists", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M20966", "name"=>"Antineoplastic Agents, Hormonal", "relevance"=>"LOW"}, {"id"=>"M22599", "name"=>"Estrogen Receptor Modulators", "relevance"=>"LOW"}, {"id"=>"M22597", "name"=>"Selective Estrogen Receptor Modulators", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Bone Density Conservation Agents", "abbrev"=>"BDCA"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Two separate cohorts will be randomized (two arms in each study cohort)"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>3832}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-05-02", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2023-12", "completionDateStruct"=>{"date"=>"2035-05-02", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2023-12-29", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2032-05-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Overall survival", "timeFrame"=>"120 months"}], "secondaryOutcomes"=>[{"measure"=>"Invasive disease-free survival", "timeFrame"=>"36 months; 60 months; 120 months"}, {"measure"=>"Distant disease-free survival", "timeFrame"=>"36 months; 60 months; 120 months"}, {"measure"=>"Breast cancer-specific survival", "timeFrame"=>"36 months; 60 months; 120 months"}, {"measure"=>"Overall survival", "timeFrame"=>"36 months; 60 months"}, {"measure"=>"Frequency of selected grade 3/4 toxicities", "timeFrame"=>"36 months; 60 months; 120 months", "description"=>"Selected grade 3 or 4 toxicities that lead to hospitalization will be captured and analyzed for each study arm."}, {"measure"=>"Overall quality of life (EORTC QLQC30)", "timeFrame"=>"24 months; 60 months", "description"=>"Assessment of overall quality of life through global health status from EORTC QLQC30 (scale 0 to 100; higher score indicates better overall quality of life)"}, {"measure"=>"Adherence to treatment strategies (medical possession ratio)", "timeFrame"=>"36 months; 60 months; 120 months", "description"=>"Adherence will be calculated by using medication possession ratio (MPR; the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period). A MPR of \\>/= 80% is defined as good adherence"}, {"measure"=>"Duration of sick leave", "timeFrame"=>"36 months; 60 months; 120 months"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["breast cancer", "adjuvant therapy", "endocrine treatment", "extended therapy"], "conditions"=>["Breast Cancer"]}, "descriptionModule"=>{"briefSummary"=>"Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice.\n\nThe primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios:\n\n* In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen.\n* In postmenopausal women at diagnosis."}, "eligibilityModule"=>{"sex"=>"FEMALE", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"90 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\nCohort 1 (premenopausal women at diagnosis converted to postmenopausal)\n\n1. Women who were pre- or perimenopausal at diagnosis\n2. Luminal breast cancer (defined as estrogen-receptor positive \\>/=10%, HER2-negative disease).\n3. Treated with tamoxifen for at least 80% of a 5-year period (+/- 6 months from treatment completion).\n4. No clinical signs of metastasis after 5 years tamoxifen treatment.\n5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.\n6. Postmenopausal status at study entry defined according to the National Comprehensive Cancer Network Guidelines.\n\nCohort 2 (postmenopausal women at breast cancer diagnosis)\n\n1. Women who were postmenopausal at diagnosis.\n2. Luminal breast cancer (defined as estrogen-receptor positive \\>/=10%, HER2-negative disease).\n3. Treated with AI for at least 80% of a 5-year period (+/- 6 months from treatment completion).\n4. No clinical signs of metastasis after 5 years AI treatment.\n5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.\n\nExclusion Criteria:\n\nCohort 1\n\n1. Prior invasive breast cancer diagnosis.\n2. Other invasive malignancy within 5 years before or after breast cancer diagnosis\n3. Non-luminal breast cancer (defined as estrogen-receptor \\< 10%).\n4. Patients who were unable to complete at least 80% of 5-year initial treatment with tamoxifen.\n5. Uncertain menopausal status (unable to evaluate menopausal status according to aforementioned definitions).\n6. Recurrent or metastatic breast cancer within or after 5-year initial treatment with tamoxifen (DCIS-only is allowed at any time before or after breast cancer diagnosis).\n\n8) Unable to give informed consent in Swedish. Cohort 2\n\n1. Prior invasive breast cancer diagnosis.\n2. Other invasive malignancy within 5 years before or after breast cancer diagnosis; non-Luminal breast cancer (defined as estrogen-receptor \\< 10%).\n3. Patients who were unable to complete at least 80% of 5-year initial treatment with AI.\n4. Recurrent or metastatic breast cancer within or after 5-year initial treatment with AI (DCIS-only is allowed at any time before or after breast cancer diagnosis).\n\n6) No contraindication for tamoxifen therapy. 7) Unable to give informed consent in Swedish."}, "identificationModule"=>{"nctId"=>"NCT06223698", "acronym"=>"SWE-Switch", "briefTitle"=>"Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer", "organization"=>{"class"=>"OTHER", "fullName"=>"Region Örebro County"}, "officialTitle"=>"Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial", "orgStudyIdInfo"=>{"id"=>"280050"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Cohort 1: Aromatase inhibitors for 5 years", "description"=>"Cohort 1 (premenopausal at diagnosis =\\> postmenopausal at randomization) 5-year tamoxifen =\\> Randomized to Arm A (switching to aromatase inhibitors for 5 years).", "interventionNames"=>["Drug: Letrozole", "Drug: Anastrozole", "Drug: Exemestane"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Cohort 1: Tamoxifen for 5 years", "description"=>"Cohort 1 (premenopausal at diagnosis =\\> postmenopausal at randomization) 5-year tamoxifen =\\> Randomized to Arm B (continuing with tamoxifen for 5 years).", "interventionNames"=>["Drug: Tamoxifen"]}, {"type"=>"EXPERIMENTAL", "label"=>"Cohort 2: Tamoxifen for 5 years", "description"=>"Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\\> Randomized to Arm A (switching to tamoxifen for 5 years).", "interventionNames"=>["Drug: Tamoxifen"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Cohort 2: Aromatase inhibitors for 2 years", "description"=>"Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\\> Randomized to Arm B (continuing with AI for 2 years).", "interventionNames"=>["Drug: Letrozole", "Drug: Anastrozole", "Drug: Exemestane"]}], "interventions"=>[{"name"=>"Letrozole", "type"=>"DRUG", "description"=>"Letrozole 2.5 mg daily", "armGroupLabels"=>["Cohort 1: Aromatase inhibitors for 5 years", "Cohort 2: Aromatase inhibitors for 2 years"]}, {"name"=>"Anastrozole", "type"=>"DRUG", "description"=>"Anastrozole 1 mg daily", "armGroupLabels"=>["Cohort 1: Aromatase inhibitors for 5 years", "Cohort 2: Aromatase inhibitors for 2 years"]}, {"name"=>"Exemestane", "type"=>"DRUG", "description"=>"Exemestane 25 mg daily", "armGroupLabels"=>["Cohort 1: Aromatase inhibitors for 5 years", "Cohort 2: Aromatase inhibitors for 2 years"]}, {"name"=>"Tamoxifen", "type"=>"DRUG", "description"=>"Tamoxifen 20 mg daily", "armGroupLabels"=>["Cohort 1: Tamoxifen for 5 years", "Cohort 2: Tamoxifen for 5 years"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Eskilstuna", "country"=>"Sweden", "contacts"=>[{"name"=>"Andreas Nearchou, MD", "role"=>"CONTACT"}, {"name"=>"Andreas Nearchou, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"General Hospital of Eskilstuna", "geoPoint"=>{"lat"=>59.36661, "lon"=>16.5077}}, {"city"=>"Falun", "country"=>"Sweden", "contacts"=>[{"name"=>"Maria Annerbo, MD", "role"=>"CONTACT"}, {"name"=>"Maria Annerbo, MD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Falun County Hospital", "geoPoint"=>{"lat"=>60.60357, "lon"=>15.62597}}, {"city"=>"Göteborg", "country"=>"Sweden", "contacts"=>[{"name"=>"Barbro Linderholm, MD, PhD", "role"=>"CONTACT"}, {"name"=>"Barbro Linderholm, MD; PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Sahlgrenska University Hospital", "geoPoint"=>{"lat"=>57.70716, "lon"=>11.96679}}, {"city"=>"Jönköping", "country"=>"Sweden", "contacts"=>[{"name"=>"Maria Ekholm, MD, PhD", "role"=>"CONTACT"}, {"name"=>"Maria Ekholm, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Ryhov County Hospital", "geoPoint"=>{"lat"=>57.78145, "lon"=>14.15618}}, {"city"=>"Lund", "country"=>"Sweden", "contacts"=>[{"name"=>"Niklas Loman, MD, PhD", "role"=>"CONTACT"}, {"name"=>"Niklas Loman, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Lund University Hospital", "geoPoint"=>{"lat"=>55.70584, "lon"=>13.19321}}, {"city"=>"Stockholm", "country"=>"Sweden", "contacts"=>[{"name"=>"Theodoros Foukakis, MD, PhD", "role"=>"CONTACT"}, {"name"=>"Theodoros Foukakis, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Alexios Matikas, MD, PhD", "role"=>"SUB_INVESTIGATOR"}], "facility"=>"Karolinska University Hospital", "geoPoint"=>{"lat"=>59.33258, "lon"=>18.0649}}, {"city"=>"Umeå", "country"=>"Sweden", "contacts"=>[{"name"=>"Anne Andersson, MD, PhD", "role"=>"CONTACT"}, {"name"=>"Anne Andersson, MD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"University Hospital of Umeå", "geoPoint"=>{"lat"=>63.82842, "lon"=>20.25972}}, {"city"=>"Uppsala", "country"=>"Sweden", "contacts"=>[{"name"=>"Henrik Lindman, MD, PhD", "role"=>"CONTACT"}, {"name"=>"Henrik Lindman, PD, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Akademiska University Hospital Uppsala", "geoPoint"=>{"lat"=>59.85882, "lon"=>17.63889}}, {"city"=>"Västerås", "country"=>"Sweden", "contacts"=>[{"name"=>"Cecilia Nilsson, MD, PhD", "role"=>"CONTACT"}, {"name"=>"Cecilia Nilsson, Md, PhD", "role"=>"PRINCIPAL_INVESTIGATOR"}], "facility"=>"Västerås General Hospital", "geoPoint"=>{"lat"=>59.61617, "lon"=>16.55276}}, {"city"=>"Örebro", "country"=>"Sweden", "contacts"=>[{"name"=>"Antonis Valachis, MD, PhD", "role"=>"CONTACT"}], "facility"=>"Örebro University Hospital", "geoPoint"=>{"lat"=>59.27412, "lon"=>15.2066}}], "centralContacts"=>[{"name"=>"Antonis Valachis, MD, PhD", "role"=>"CONTACT", "email"=>"antonios.valachis@oru.se", "phone"=>"0046 196021000"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Region Örebro County", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Mid-Sweden Regional Cancer Centre", "class"=>"UNKNOWN"}, {"name"=>"Akademiska University Hospital, Uppsala, Sweden", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
