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NCT00530868

Comparing Letrozole Given Alone to Letrozole Given With Avastin in Post-Menopausal Women Breast Cancer

Version 12 to 13 · University of Alabama at Birmingham

Patch inspector

Version 12 to 13

21 operations 4 path groups ctgov_internal_history
ClinicalTrials.gov
Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip the pipeline's suppression passes); the authoritative classification is the stored event record.
Plain-language summary

Manual review pending.

Rules fired
arms_or_interventions_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "high",
    "direction": "later",
    "new_value": "2012-12",
    "old_value": "2011-12",
    "delta_days": 366,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2013-12",
    "old_value": "2012-12",
    "delta_days": 365,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:47+00
Raw hash
bb2e79becd455b086a01a3459c451c0b570307208ba94543c15eafa688ace33a
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 10 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
1
After
Letrozole + Avastin
remove /protocolSection/armsInterventionsModule/armGroups/0/description
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Letrozole plus Avastin
remove /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Letrozole (Femara)
replace /protocolSection/armsInterventionsModule/armGroups/1/label
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
2
After
Letrozole alone
remove /protocolSection/armsInterventionsModule/armGroups/1/description
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Letrozole alone.
remove /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Letrozole; Avastin
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 18
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
1
After
Letrozole alone
remove /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
2
replace /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
1
After
Letrozole + Avastin
remove /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/1
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
2
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2011-12
After
2012-12
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2012-12
After
2013-12
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2011-06
After
2012-05
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2011-06-14
After
2012-05-08
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2011-06-16
After
2012-05-09
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 6 ops
remove /protocolSection/sponsorCollaboratorsModule/responsibleParty/oldNameTitle
Triage: Uncategorized
Uncategorized Operation 6
Before
Andres Forero, M.D./Principal Investigator
remove /protocolSection/sponsorCollaboratorsModule/responsibleParty/oldOrganization
Triage: Uncategorized
Uncategorized Operation 7
Before
UAB
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/type
Triage: Uncategorized
Uncategorized Operation 8
After
PRINCIPAL_INVESTIGATOR
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName
Triage: Uncategorized
Uncategorized Operation 9
After
Andres Forero
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle
Triage: Uncategorized
Uncategorized Operation 10
After
Professor, Medicine
add /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorAffiliation
Triage: Uncategorized
Uncategorized Operation 11
After
University of Alabama at Birmingham
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2012-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2012-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2013-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2012-05-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2012-05-09"
  },
  {
    "op": "remove",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/oldNameTitle"
  },
  {
    "op": "remove",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/oldOrganization"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/type",
    "value": "PRINCIPAL_INVESTIGATOR"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName",
    "value": "Andres Forero"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorTitle",
    "value": "Professor, Medicine"
  },
  {
    "op": "add",
    "path": "/protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorAffiliation",
    "value": "University of Alabama at Birmingham"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Letrozole + Avastin"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/label",
    "value": "Letrozole alone"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/description"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Letrozole alone"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
    "value": "Letrozole + Avastin"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/1"
  }
]