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NCT02229084

Vaccination of High Risk Breast Cancer Patients

A Combined Phase I/II Feasibility-and-Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy

ClinicalTrials.gov
Sponsor
University of Arkansas
Status
Completed
Versions
20
Adjacent patches
19
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. New Evidence Record packages are generated for deterministic event-class membership, not by triage rank alone.

Material event timeline

13 shown
Triage: Medium
2014-12-17
Timeline Major Slip
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Low
2015-01-14
Timeline Minor Adjustment
v1 to v2 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Medium
2016-01-21
Timeline Major Slip
v3 to v4 Early Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2016-12-06
Timeline Significant Shift
v5 to v6 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2018-01-31
Eligibility Change
v7 to v8 Early Recruitment Inspect patch
/protocolSection/descriptionModule/briefSummary
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/completionDateStruct/date
Triage: Medium
2019-03-07
Timeline Major Slip
v9 to v10 Early Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2020-03-11
Timeline Major Slip
v10 to v11 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/overallOfficials/0/name
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Critical
2021-03-15
Primary Outcome Change
v11 to v12 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/label
Triage: Critical
2021-04-02
Primary Outcome Change
v12 to v13 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: Medium
2022-03-14
Timeline Major Slip
v13 to v14 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/email
/protocolSection/contactsLocationsModule/centralContacts/0/name
/protocolSection/contactsLocationsModule/centralContacts/0/phone
Triage: High
2023-01-26
Enrollment Change
v14 to v15 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/contacts
Triage: High
2024-04-26
Arm Intervention Change
v16 to v17 Post Recruitment Inspect patch Evidence Record
/annotationSection
/documentSection/largeDocumentModule/largeDocs/1/filename
/documentSection/largeDocumentModule/largeDocs/1/size
Triage: Low
2024-05-28
Results Reconciliation
v17 to v18 Post Recruitment Inspect patch Evidence Record
/protocolSection/outcomesModule/primaryOutcomes/1/description
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate