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NCT01142401

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

Version 18 to 19 · National Cancer Institute (NCI)

Patch inspector

Version 18 to 19

24 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_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:12+00
Raw hash
534baf30398229fcedfe06a86799a2ee1be4454ad6e53a6ff13f72283cde4b6f
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 14 ops
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: fulvestrant
After
Drug: Fulvestrant
replace /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: laboratory biomarker analysis
After
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: fulvestrant
After
Drug: Fulvestrant
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: bortezomib
After
Drug: Bortezomib
replace /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2
Triage: High
Arm Intervention Change Operation 15
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: laboratory biomarker analysis
After
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0
Triage: High
Arm Intervention Change Operation 16
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Drug: fulvestrant
After
Drug: Fulvestrant
replace /protocolSection/armsInterventionsModule/armGroups/2/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: bortezomib
After
Drug: Bortezomib
replace /protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2
Triage: High
Arm Intervention Change Operation 18
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: laboratory biomarker analysis
After
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 19
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
fulvestrant
After
Fulvestrant
remove /protocolSection/armsInterventionsModule/interventions/0/otherNames/0
Triage: High
Arm Intervention Change Operation 20
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Faslodex
add /protocolSection/armsInterventionsModule/interventions/0/otherNames/1
Triage: High
Arm Intervention Change Operation 21
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
ZD9238
replace /protocolSection/armsInterventionsModule/interventions/1/name
Triage: High
Arm Intervention Change Operation 22
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
bortezomib
After
Bortezomib
remove /protocolSection/armsInterventionsModule/interventions/1/otherNames
Triage: High
Arm Intervention Change Operation 23
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "LDP 341",
  "MLN341",
  "VELCADE"
]
replace /protocolSection/armsInterventionsModule/interventions/2/name
Triage: High
Arm Intervention Change Operation 24
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
laboratory biomarker analysis
After
Laboratory Biomarker Analysis
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 7
Before
2014-11-15
After
2014-11-21
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 8
Before
2014-11-18
After
2014-11-24
replace /protocolSection/conditionsModule/conditions/0
Triage: Uncategorized
Uncategorized Operation 9
Before
Estrogen Receptor-positive Breast Cancer
After
Estrogen Receptor Positive
replace /protocolSection/conditionsModule/conditions/1
Triage: Uncategorized
Uncategorized Operation 10
Before
Recurrent Breast Cancer
After
Recurrent Breast Carcinoma
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 6 ops
add /protocolSection/identificationModule/secondaryIdInfos/5
Triage: Uncategorized
Uncategorized Operation 1
After
{
  "id": "N01CM62204",
  "link": "https://reporter.nih.gov/quickSearch/N01CM62204",
  "type": "NIH"
}
add /protocolSection/identificationModule/secondaryIdInfos/6
Triage: Uncategorized
Uncategorized Operation 2
After
{
  "id": "N01CM00070",
  "link": "https://reporter.nih.gov/quickSearch/N01CM00070",
  "type": "NIH"
}
remove /protocolSection/identificationModule/secondaryIdInfos/8
Triage: Uncategorized
Uncategorized Operation 3
Before
{
  "id": "N01CM00070",
  "link": "https://reporter.nih.gov/quickSearch/N01CM00070",
  "type": "NIH"
}
remove /protocolSection/identificationModule/secondaryIdInfos/8
Triage: Uncategorized
Uncategorized Operation 4
Before
{
  "id": "P30CA013330",
  "link": "https://reporter.nih.gov/quickSearch/P30CA013330",
  "type": "NIH"
}
remove /protocolSection/identificationModule/secondaryIdInfos/8
Triage: Uncategorized
Uncategorized Operation 5
Before
{
  "id": "N01CM62204",
  "link": "https://reporter.nih.gov/quickSearch/N01CM62204",
  "type": "NIH"
}
add /protocolSection/identificationModule/secondaryIdInfos/10
Triage: Uncategorized
Uncategorized Operation 6
After
{
  "id": "P30CA013330",
  "link": "https://reporter.nih.gov/quickSearch/P30CA013330",
  "type": "NIH"
}
Raw JSON Patch 
[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/5",
    "value": {
      "id": "N01CM62204",
      "link": "https://reporter.nih.gov/quickSearch/N01CM62204",
      "type": "NIH"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/6",
    "value": {
      "id": "N01CM00070",
      "link": "https://reporter.nih.gov/quickSearch/N01CM00070",
      "type": "NIH"
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/8"
  },
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/8"
  },
  {
    "op": "remove",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/8"
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/10",
    "value": {
      "id": "P30CA013330",
      "link": "https://reporter.nih.gov/quickSearch/P30CA013330",
      "type": "NIH"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2014-11-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2014-11-24"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/0",
    "value": "Estrogen Receptor Positive"
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/conditions/1",
    "value": "Recurrent Breast Carcinoma"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Drug: Fulvestrant"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Drug: Fulvestrant"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/1",
    "value": "Drug: Bortezomib"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/2",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
    "value": "Drug: Fulvestrant"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/1",
    "value": "Drug: Bortezomib"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/2",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Fulvestrant"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/1",
    "value": "ZD9238"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/name",
    "value": "Bortezomib"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/name",
    "value": "Laboratory Biomarker Analysis"
  }
]