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NCT01142401

Fulvestrant With or Without Bortezomib in Patients With Inoperable Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Version 31 to 32 · National Cancer Institute (NCI)

Patch inspector

Version 31 to 32

28 operations 5 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_type_changesecondary_outcome_any_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": "2017-06",
    "old_value": "2014-06",
    "delta_days": 1096,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:15+00
Raw hash
2cf905168eb35b85353c8a9bb18d4040cc5c7bcd9fa34eb427d48301da3670b1
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 18 ops
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 9
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ACTUAL
After
ESTIMATED
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Bortezomib
remove /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Bortezomib
add /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Drug: Bortezomib
remove /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: Bortezomib
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Fulvestrant
After
Bortezomib
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Given IM
After
Given IV
remove /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Arm A (fulvestrant)
replace /protocolSection/armsInterventionsModule/interventions/0/otherNames/0
Triage: High
Arm Intervention Change Operation 17
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
ICI 182,780
After
[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid
replace /protocolSection/armsInterventionsModule/interventions/0/otherNames/1
Triage: High
Arm Intervention Change Operation 18
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
ZD9238
After
LDP 341
add /protocolSection/armsInterventionsModule/interventions/0/otherNames/2
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
MLN341
add /protocolSection/armsInterventionsModule/interventions/0/otherNames/3
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
PS-341
add /protocolSection/armsInterventionsModule/interventions/0/otherNames/4
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
PS341
add /protocolSection/armsInterventionsModule/interventions/0/otherNames/5
Triage: High
Arm Intervention Change Operation 22
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Velcade
replace /protocolSection/armsInterventionsModule/interventions/1/name
Triage: High
Arm Intervention Change Operation 23
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Bortezomib
After
Fulvestrant
replace /protocolSection/armsInterventionsModule/interventions/1/description
Triage: High
Arm Intervention Change Operation 24
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Given IV
After
Given IM
add /protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0
Triage: High
Arm Intervention Change Operation 25
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Arm A (fulvestrant)
add /protocolSection/armsInterventionsModule/interventions/1/otherNames
Triage: High
Arm Intervention Change Operation 26
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "Faslodex",
  "Faslodex(ICI 182,780)",
  "ICI 182,780",
  "ICI 182780",
  "ZD9238"
]
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 2 ops
add /protocolSection/outcomesModule/secondaryOutcomes/1
Triage: High
Secondary Outcome Change Operation 27
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Overall survival",
  "timeFrame": "The time from first treatment day until death, assessed up to 4 years",
  "description": "Estimated using the Kaplan-Meier method.\nThe comparison of the overall survival distributions between the treatment arms will be performed by the log-rank test."
}
remove /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 28
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Overall survival",
  "timeFrame": "The time from first treatment day until death, assessed up to 4 years",
  "description": "Estimated using the Kaplan-Meier method.\nThe comparison of the overall survival distributions between the treatment arms will be performed by the log-rank test."
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2014-06
After
2017-06
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ACTUAL
After
ESTIMATED
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 7
Before
2015-03-10
After
2015-04-24
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 8
Before
2015-03-11
After
2015-04-27
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 4 ops
remove /protocolSection/identificationModule/secondaryIdInfos/5
Triage: Uncategorized
Uncategorized Operation 1
Before
{
  "id": "N01CM62204",
  "link": "https://reporter.nih.gov/quickSearch/N01CM62204",
  "type": "NIH"
}
remove /protocolSection/identificationModule/secondaryIdInfos/6
Triage: Uncategorized
Uncategorized Operation 2
Before
{
  "id": "U01CA076576",
  "link": "https://reporter.nih.gov/quickSearch/U01CA076576",
  "type": "NIH"
}
add /protocolSection/identificationModule/secondaryIdInfos/7
Triage: Uncategorized
Uncategorized Operation 3
After
{
  "id": "N01CM62204",
  "link": "https://reporter.nih.gov/quickSearch/N01CM62204",
  "type": "NIH"
}
add /protocolSection/identificationModule/secondaryIdInfos/10
Triage: Uncategorized
Uncategorized Operation 4
After
{
  "id": "U01CA076576",
  "link": "https://reporter.nih.gov/quickSearch/U01CA076576",
  "type": "NIH"
}
Raw JSON Patch 
[
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/5"
  },
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/6"
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/7",
    "value": {
      "id": "N01CM62204",
      "link": "https://reporter.nih.gov/quickSearch/N01CM62204",
      "type": "NIH"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/10",
    "value": {
      "id": "U01CA076576",
      "link": "https://reporter.nih.gov/quickSearch/U01CA076576",
      "type": "NIH"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2017-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ESTIMATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-04-24"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-04-27"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ESTIMATED"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Drug: Bortezomib"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
    "value": "Drug: Bortezomib"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Bortezomib"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "Given IV"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
    "value": "[(1R)-3-Methyl-1-[[(2S)-1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl]boronic Acid"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/1",
    "value": "LDP 341"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/2",
    "value": "MLN341"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/3",
    "value": "PS-341"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/4",
    "value": "PS341"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/5",
    "value": "Velcade"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/name",
    "value": "Fulvestrant"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/description",
    "value": "Given IM"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/armGroupLabels/0",
    "value": "Arm A (fulvestrant)"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames",
    "value": [
      "Faslodex",
      "Faslodex(ICI 182,780)",
      "ICI 182,780",
      "ICI 182780",
      "ZD9238"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1",
    "value": {
      "measure": "Overall survival",
      "timeFrame": "The time from first treatment day until death, assessed up to 4 years",
      "description": "Estimated using the Kaplan-Meier method.\nThe comparison of the overall survival distributions between the treatment arms will be performed by the log-rank test."
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3"
  }
]