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NCT01033032

Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Phase I/II Trial of Amrubicin as Second- or Third-Line Treatment for Patients With HER2-Negative Metastatic Breast Cancer

ClinicalTrials.gov
Sponsor
SCRI Development Innovations, LLC
Status
Completed
Versions
18
Adjacent patches
17
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

12 shown
Triage: Low
2009-12-29
Administrative Contact Change
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/overallOfficials
Triage: High
2010-06-29
Eligibility Change
v2 to v3 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Low
2010-08-03
Administrative Contact Change
v4 to v5 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/phone
/protocolSection/contactsLocationsModule/centralContacts/1/email
/protocolSection/contactsLocationsModule/centralContacts/1/name
Triage: Medium
2011-05-03
Timeline Major Slip
v6 to v7 Early Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2012-06-05
Timeline Significant Shift
v8 to v9 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: High
2013-06-26
Design Change
v9 to v10 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/13/zip
/protocolSection/designModule/designInfo/allocation
/protocolSection/statusModule/completionDateStruct/date
Triage: High
2013-08-15
Arm Intervention Change
v10 to v11 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
/protocolSection/designModule/enrollmentInfo/count
Triage: Critical
2013-12-02
Primary Outcome Change
v12 to v13 Late Recruitment Inspect patch
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/outcomesModule/primaryOutcomes/0/measure
/protocolSection/outcomesModule/primaryOutcomes/1/measure
Triage: Medium
2014-04-01
Timeline Shift
v13 to v14 Late Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
2014-07-17
Timeline Significant Shift
v14 to v15 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2014-12-22
Arm Intervention Change
v15 to v16 Late Recruitment Inspect patch Evidence Record
/hasResults
/protocolSection/armsInterventionsModule/armGroups/0/label
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
2022-04-05
Arm Intervention Change
v16 to v17 Post Recruitment Inspect patch Evidence Record
/protocolSection/armsInterventionsModule/interventions/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/measure