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NCT01275677

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel) to Chemotherapy Plus Trastuzumab in Women With Node-Positive or High-Risk Node-Negative HER2-Low Invasive Breast Cancer

ClinicalTrials.gov
Sponsor
National Cancer Institute (NCI)
Status
Completed
Versions
980
Adjacent patches
979
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

31 shown
Triage: Medium
2011-01-12
Timeline Major Slip
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/startDateStruct/date
Triage: Medium
2011-06-30
Timeline Major Slip
v79 to v80 Early Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: High
2012-01-07
Arm Intervention Change
v174 to v175 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/3/description
/protocolSection/descriptionModule/detailedDescription
/protocolSection/eligibilityModule/eligibilityCriteria
Triage: Critical
2012-12-04
Primary Outcome Change
v191 to v192 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
2013-05-06
Eligibility Change
v192 to v193 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/107/contacts
/protocolSection/contactsLocationsModule/locations/107/status
/protocolSection/contactsLocationsModule/locations/116/contacts
Triage: High
2014-04-21
Secondary Outcome Change
v195 to v196 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1/status
/protocolSection/contactsLocationsModule/locations/1000
/protocolSection/contactsLocationsModule/locations/1005/contacts
Triage: Critical
2014-07-07
Primary Outcome Change
v202 to v203 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3
/protocolSection/armsInterventionsModule/armGroups/2/description
Triage: High
2014-08-12
Arm Intervention Change
v213 to v214 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames/3
/protocolSection/contactsLocationsModule/locations/200/contacts
/protocolSection/contactsLocationsModule/locations/200/status
Triage: High
2014-11-21
Arm Intervention Change
v261 to v262 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
2015-02-20
Eligibility Change
v308 to v309 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
/protocolSection/contactsLocationsModule/locations/10/city
Triage: High
2015-04-09
Arm Intervention Change
v341 to v342 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/4
Triage: High
2015-12-14
Arm Intervention Change
v499 to v500 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/0
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2016-02-16
Arm Intervention Change
v541 to v542 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/6/otherNames/18
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2017-05-03
Timeline Significant Shift
v774 to v775 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1087/zip
/protocolSection/contactsLocationsModule/locations/1188/facility
/protocolSection/contactsLocationsModule/locations/1190/facility
Triage: Medium
2017-05-23
Timeline Shift
v787 to v788 Late Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: High
2017-07-10
Arm Intervention Change
v818 to v819 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/2/otherNames/4
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2017-08-14
Arm Intervention Change
v843 to v844 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames
/protocolSection/armsInterventionsModule/interventions/1/otherNames
/protocolSection/armsInterventionsModule/interventions/2/otherNames
Triage: High
2018-04-09
Arm Intervention Change
v858 to v859 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames
/protocolSection/armsInterventionsModule/interventions/1/otherNames
/protocolSection/armsInterventionsModule/interventions/2/otherNames
Triage: High
2018-06-11
Arm Intervention Change
v871 to v872 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/6/otherNames/21
/protocolSection/contactsLocationsModule/locations/1010/facility
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2019-03-22
Enrollment Change
v903 to v904 Late Recruitment Inspect patch
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2019-05-01
Arm Intervention Change
v906 to v907 Late Recruitment Inspect patch
/annotationSection
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
2020-09-01
Enrollment Change
v907 to v908 Late Recruitment Inspect patch Evidence Record
/annotationSection
/documentSection/largeDocumentModule/largeDocs/0/date
/hasResults
Triage: High
2021-01-20
Arm Intervention Change
v908 to v909 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames/15
/protocolSection/armsInterventionsModule/interventions/2/otherNames/1
/protocolSection/armsInterventionsModule/interventions/3/otherNames/16
Triage: High
2021-02-25
Arm Intervention Change
v910 to v911 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/7/otherNames/28
/protocolSection/armsInterventionsModule/interventions/7/otherNames/31
/protocolSection/contactsLocationsModule/locations/767/facility
Triage: High
2023-06-16
Arm Intervention Change
v942 to v943 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/7/otherNames/22
/protocolSection/armsInterventionsModule/interventions/7/otherNames/23
/protocolSection/armsInterventionsModule/interventions/7/otherNames/24
Triage: High
2023-08-15
Arm Intervention Change
v943 to v944 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/7/otherNames/2
/protocolSection/armsInterventionsModule/interventions/7/otherNames/20
/protocolSection/armsInterventionsModule/interventions/7/otherNames/3
Triage: High
2023-09-20
Arm Intervention Change
v945 to v946 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames/2
/protocolSection/armsInterventionsModule/interventions/0/otherNames/3
/protocolSection/armsInterventionsModule/interventions/0/otherNames/36
Triage: High
2024-07-13
Arm Intervention Change
v956 to v957 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames/3
/protocolSection/armsInterventionsModule/interventions/0/otherNames/37
/protocolSection/armsInterventionsModule/interventions/0/otherNames/40
Triage: High
2025-02-05
Arm Intervention Change
v968 to v969 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/7/otherNames/14
/protocolSection/armsInterventionsModule/interventions/7/otherNames/15
/protocolSection/armsInterventionsModule/interventions/7/otherNames/16
Triage: Low
2025-06-04
Timeline Actual Date Correction
v977 to v978 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Low
2025-06-25
Results Reconciliation
v978 to v979 Post Recruitment Inspect patch Evidence Record
/protocolSection/outcomesModule/otherOutcomes
/protocolSection/outcomesModule/secondaryOutcomes/6
/protocolSection/statusModule/lastUpdatePostDateStruct/date