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NCT00769379

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently With Radiation Therapy and Radiation Therapy Alone for Women With HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy

ClinicalTrials.gov
Sponsor
National Cancer Institute (NCI)
Status
Completed
Versions
1,651
Adjacent patches
1,650
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

38 shown
Triage: Medium
2008-11-13
Timeline Major Slip
v1 to v2 Pre Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/startDateStruct/date
Triage: Medium
2008-11-16
Timeline Major Slip
v2 to v3 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2008-11-21
Eligibility Change
v5 to v6 Early Recruitment Inspect patch
/protocolSection/descriptionModule/detailedDescription
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2009-02-04
Arm Intervention Change
v42 to v43 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
Triage: Medium
2011-09-07
Timeline Major Slip
v499 to v500 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/24
/protocolSection/contactsLocationsModule/locations/452
/protocolSection/contactsLocationsModule/locations/472
Triage: Critical
2013-01-14
Primary Outcome Change
v618 to v619 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/0/type
Triage: High
2013-10-07
Arm Intervention Change
v620 to v621 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames
/protocolSection/armsInterventionsModule/interventions/1/otherNames
/protocolSection/contactsLocationsModule/locations/0/city
Triage: High
2014-04-09
Arm Intervention Change
v621 to v622 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/0/otherNames
/protocolSection/armsInterventionsModule/interventions/1/otherNames
/protocolSection/contactsLocationsModule/locations/1/status
Triage: Critical
2014-06-23
Primary Outcome Change
v627 to v628 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
2014-11-21
Arm Intervention Change
v688 to v689 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
2015-04-09
Arm Intervention Change
v777 to v778 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
2015-05-12
Eligibility Change
v799 to v800 Late Recruitment Inspect patch
/protocolSection/conditionsModule/conditions/1
/protocolSection/descriptionModule/detailedDescription
/protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
2016-02-16
Arm Intervention Change
v978 to v979 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/18
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Medium
2017-05-23
Timeline Shift
v1285 to v1286 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/58/facility
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2017-08-14
Arm Intervention Change
v1341 to v1342 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2017-09-05
Arm Intervention Change
v1356 to v1357 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2017-10-13
Enrollment Change
v1384 to v1385 Late Recruitment Inspect patch
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2017-10-24
Enrollment Change
v1391 to v1392 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/221/facility
/protocolSection/contactsLocationsModule/locations/223
/protocolSection/contactsLocationsModule/locations/225
Triage: High
2018-01-16
Arm Intervention Change
v1445 to v1446 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/16
/protocolSection/armsInterventionsModule/interventions/1/otherNames/22
/protocolSection/contactsLocationsModule/locations/539/facility
Triage: High
2018-03-02
Secondary Outcome Change
v1477 to v1478 Late Recruitment Inspect patch
/protocolSection/outcomesModule/secondaryOutcomes/0
/protocolSection/outcomesModule/secondaryOutcomes/3
/protocolSection/outcomesModule/secondaryOutcomes/5
Triage: High
2018-06-11
Arm Intervention Change
v1500 to v1501 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/21
/protocolSection/contactsLocationsModule/locations/1011/facility
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2019-06-20
Arm Intervention Change
v1531 to v1532 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/1
/protocolSection/armsInterventionsModule/interventions/1/otherNames/14
/protocolSection/armsInterventionsModule/interventions/1/otherNames/19
Triage: High
2019-08-12
Arm Intervention Change
v1538 to v1539 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/23
/protocolSection/armsInterventionsModule/interventions/1/otherNames/29
/protocolSection/armsInterventionsModule/interventions/1/otherNames/31
Triage: High
2020-01-20
Arm Intervention Change
v1560 to v1561 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/31
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2020-02-03
Arm Intervention Change
v1561 to v1562 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/31
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2020-05-02
Arm Intervention Change
v1576 to v1577 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/31
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2020-07-29
Enrollment Change
v1581 to v1582 Late Recruitment Inspect patch
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2020-10-20
Arm Intervention Change
v1588 to v1589 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/15
/protocolSection/armsInterventionsModule/interventions/1/otherNames/28
/protocolSection/armsInterventionsModule/interventions/1/otherNames/32
Triage: Low
2022-01-31
Results Reconciliation
v1590 to v1591 Late Recruitment Inspect patch Evidence Record
/annotationSection
/hasResults
/protocolSection/outcomesModule/primaryOutcomes/0/description
Triage: High
2022-03-09
Arm Intervention Change
v1591 to v1592 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/28
/protocolSection/armsInterventionsModule/interventions/1/otherNames/31
/protocolSection/contactsLocationsModule/locations/1029
Triage: High
2023-06-16
Arm Intervention Change
v1610 to v1611 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/22
/protocolSection/armsInterventionsModule/interventions/1/otherNames/23
/protocolSection/armsInterventionsModule/interventions/1/otherNames/24
Triage: High
2023-08-15
Arm Intervention Change
v1613 to v1614 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/2
/protocolSection/armsInterventionsModule/interventions/1/otherNames/20
/protocolSection/armsInterventionsModule/interventions/1/otherNames/3
Triage: High
2023-09-20
Arm Intervention Change
v1615 to v1616 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/10
/protocolSection/armsInterventionsModule/interventions/1/otherNames/2
/protocolSection/armsInterventionsModule/interventions/1/otherNames/3
Triage: Medium
2024-03-08
Timeline Shift
v1621 to v1622 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2024-07-10
Arm Intervention Change
v1628 to v1629 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/12
/protocolSection/armsInterventionsModule/interventions/1/otherNames/36
/protocolSection/armsInterventionsModule/interventions/1/otherNames/39
Triage: High
2024-12-21
Arm Intervention Change
v1639 to v1640 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/interventions/1/otherNames/14
/protocolSection/armsInterventionsModule/interventions/1/otherNames/15
/protocolSection/armsInterventionsModule/interventions/1/otherNames/16
Triage: High
2025-03-28
Timeline Major Slip
v1646 to v1647 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/156/facility
/protocolSection/contactsLocationsModule/locations/163/facility
/protocolSection/contactsLocationsModule/locations/386/facility
Triage: Low
2025-06-03
Timeline Actual Date Correction
v1649 to v1650 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date