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NCT00490139

ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D

A Randomised, Multi-centre, Open-label, Phase III Study of Adjuvant Lapatinib, Trastuzumab, Their Sequence and Their Combination in Patients With HER2/ErbB2 Positive Primary Breast Cancer

ClinicalTrials.gov
Sponsor
Novartis Pharmaceuticals
Status
Completed
Versions
203
Adjacent patches
202
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

34 shown
Triage: Critical
2007-11-02
Primary Outcome Change
v3 to v4 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/142
/protocolSection/contactsLocationsModule/locations/2
/protocolSection/contactsLocationsModule/locations/435/city
Triage: High
2007-12-12
Eligibility Change
v5 to v6 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Critical
2008-01-22
Primary Outcome Change
v6 to v7 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0
/protocolSection/contactsLocationsModule/locations/1
/protocolSection/contactsLocationsModule/locations/100/status
Triage: High
2008-02-12
Eligibility Change
v7 to v8 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2008-02-20
Eligibility Change
v8 to v9 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/104/city
/protocolSection/contactsLocationsModule/locations/104/geoPoint
/protocolSection/contactsLocationsModule/locations/12/city
Triage: Medium
2008-03-19
Timeline Shift
v11 to v12 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1
/protocolSection/contactsLocationsModule/locations/101/status
/protocolSection/contactsLocationsModule/locations/101/zip
Triage: High
2008-04-03
Eligibility Change
v16 to v17 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/10
/protocolSection/contactsLocationsModule/locations/19
/protocolSection/contactsLocationsModule/locations/21
Triage: Medium
2008-07-15
Timeline Shift
v27 to v28 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/10
/protocolSection/contactsLocationsModule/locations/1001/status
/protocolSection/contactsLocationsModule/locations/1002/status
Triage: High
2008-07-31
Eligibility Change
v31 to v32 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/264
/protocolSection/contactsLocationsModule/locations/293
/protocolSection/contactsLocationsModule/locations/294
Triage: High
2008-09-12
Secondary Outcome Change
v41 to v42 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/143
/protocolSection/contactsLocationsModule/locations/151
/protocolSection/contactsLocationsModule/locations/153
Triage: Critical
2009-05-14
Primary Outcome Change
v42 to v43 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels
/protocolSection/armsInterventionsModule/interventions/0/description
Triage: Medium
2009-09-17
Timeline Major Slip
v61 to v62 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1256/zip
/protocolSection/contactsLocationsModule/locations/161
/protocolSection/contactsLocationsModule/locations/163
Triage: High
2009-12-17
Eligibility Change
v73 to v74 Early Recruitment Inspect patch
/protocolSection/conditionsModule/keywords/3
/protocolSection/contactsLocationsModule/locations/172
/protocolSection/contactsLocationsModule/locations/174
Triage: High
2010-02-18
Arm Intervention Change
v81 to v82 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/2
/protocolSection/armsInterventionsModule/armGroups/4
/protocolSection/contactsLocationsModule/locations/102
Triage: High
2010-02-25
Arm Intervention Change
v82 to v83 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/2
/protocolSection/armsInterventionsModule/armGroups/4
/protocolSection/contactsLocationsModule/locations/102
Triage: Critical
2010-07-01
Primary Outcome Change
v99 to v100 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/103
/protocolSection/contactsLocationsModule/locations/105/city
/protocolSection/contactsLocationsModule/locations/105/geoPoint/lat
Triage: Critical
2010-11-18
Primary Outcome Change
v102 to v103 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2
/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0
Triage: Low
2011-01-22
Administrative Contact Change
v110 to v111 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/email
/protocolSection/contactsLocationsModule/locations/1166
/protocolSection/contactsLocationsModule/locations/1168
Triage: Low
2011-01-28
Administrative Contact Change
v112 to v113 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/email
/protocolSection/contactsLocationsModule/locations/0/contacts/0/email
/protocolSection/contactsLocationsModule/locations/0/contacts/1/email
Triage: Critical
2011-08-18
Primary Outcome Change
v120 to v121 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/100
/protocolSection/contactsLocationsModule/locations/101
/protocolSection/contactsLocationsModule/locations/103
Triage: High
2011-09-15
Enrollment Change
v121 to v122 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2011-11-23
Arm Intervention Change
v130 to v131 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/1/description
/protocolSection/contactsLocationsModule/locations/897
/protocolSection/descriptionModule/briefSummary
Triage: High
2012-03-22
Arm Intervention Change
v144 to v145 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
/protocolSection/contactsLocationsModule/locations/556/city
Triage: High
2013-05-14
Enrollment Change
v171 to v172 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: High
2013-10-24
Arm Intervention Change
v172 to v173 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/1/description
/protocolSection/armsInterventionsModule/armGroups/2/description
Triage: Low
2014-07-03
Timeline Actual Date Correction
v189 to v190 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1281/city
/protocolSection/contactsLocationsModule/locations/1281/geoPoint
/protocolSection/contactsLocationsModule/locations/1281/zip
Triage: Low
2014-07-30
Results Reconciliation
v190 to v191 Late Recruitment Inspect patch Evidence Record
/hasResults
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Low
2014-09-29
Results Reconciliation
v191 to v192 Late Recruitment Inspect patch Evidence Record
/protocolSection/conditionsModule/keywords/0
/protocolSection/conditionsModule/keywords/2
/protocolSection/conditionsModule/keywords/3
Triage: High
2017-05-23
Design Change
v194 to v195 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1031
/protocolSection/contactsLocationsModule/locations/1037
/protocolSection/contactsLocationsModule/locations/1042
Triage: High
2018-10-04
Arm Intervention Change
v196 to v197 Late Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
/protocolSection/contactsLocationsModule/locations/1193
Triage: High
2019-05-14
Enrollment Change
v197 to v198 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1276/zip
/protocolSection/contactsLocationsModule/locations/1278/zip
/protocolSection/contactsLocationsModule/locations/1279/zip
Triage: High
2019-08-29
Enrollment Change
v198 to v199 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/1076
/protocolSection/contactsLocationsModule/locations/1077
/protocolSection/contactsLocationsModule/locations/1114/zip
Triage: Low
2021-07-22
Milestone Realized
v200 to v201 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Critical
2025-03-04
Serious Adverse Event Removal
v201 to v202 Post Recruitment Inspect patch Evidence Record
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/armGroups/0/label