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NCT01033032

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

Version 10 to 11 · SCRI Development Innovations, LLC

Patch inspector

Version 10 to 11

10 operations 3 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_changeenrollment_count_changeenrollment_type_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ACTUAL",
    "severity": "high",
    "direction": "later",
    "new_value": "2014-03",
    "old_value": "2010-12",
    "delta_days": 1186,
    "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": "2014-11",
    "old_value": "2013-12",
    "delta_days": 335,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 78,
    "old_value": 60,
    "pct_change": 0.3
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:42+00
Raw hash
250ca63f7c87dc0d7441f29b07a643407db672fa2891859ea1558886ff1d1136
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 4 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 7
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
60
After
78
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 8
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/armsInterventionsModule/armGroups/0/label
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
1
After
Amrubicin
replace /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
1
After
Amrubicin
Timeline Start, primary completion, and completion date movement. Triage: Medium 3 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
2010-12
After
2014-03
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ACTUAL
After
ESTIMATED
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2013-12
After
2014-11
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
2013-06
After
2013-08
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2013-06-26
After
2013-08-15
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2013-06-27
After
2013-08-16
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2013-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2014-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ESTIMATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2014-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2013-08-15"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2013-08-16"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 78
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/label",
    "value": "Amrubicin"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Amrubicin"
  }
]