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NCT00769379

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

Version 777 to 778 · National Cancer Institute (NCI)

Patch inspector

Version 777 to 778

17 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_changesecondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:50:41+00
Raw hash
050f9720de39baf6bb05767f6b25813423916e48c14af5671183894ba41d6885
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 11 ops
add /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
Triage: High
Arm Intervention Change Operation 3
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: Laboratory Biomarker Analysis
remove /protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2
Triage: High
Arm Intervention Change Operation 4
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Laboratory Biomarker Analysis
add /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0
Triage: High
Arm Intervention Change Operation 5
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
Other: Laboratory Biomarker Analysis
remove /protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3
Triage: High
Arm Intervention Change Operation 6
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Other: Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/interventions/0/type
Triage: High
Arm Intervention Change Operation 7
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
BIOLOGICAL
After
OTHER
replace /protocolSection/armsInterventionsModule/interventions/0/name
Triage: High
Arm Intervention Change Operation 8
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Trastuzumab
After
Laboratory Biomarker Analysis
replace /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Given IV
After
Correlative studies
add /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.
After
Arm I (standard WBI)
remove /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
[
  "ABP 980",
  "PF-05280014",
  "rhuMAb HER2"
]
add /protocolSection/armsInterventionsModule/interventions/1
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
{
  "name": "Trastuzumab",
  "type": "BIOLOGICAL",
  "otherNames": [
    "ABP 980",
    "Anti-c-ERB-2",
    "Anti-c-erbB2 Monoclonal Antibody",
    "Anti-ERB-2",
    "Anti-erbB-2",
    "Anti-erbB2 Monoclonal Antibody",
    "Anti-HER2/c-erbB2 Monoclonal Antibody",
    "Anti-p185-HER2",
    "c-erb-2 Monoclonal Antibody",
    "HER2 Monoclonal Antibody",
    "Herceptin",
    "Herceptin Biosimilar PF-05280014",
    "Herceptin Trastuzumab Biosimilar PF-05280014",
    "MoAb HER2",
    "Monoclonal Antibody c-erb-2",
    "Monoclonal Antibody HER2",
    "PF-05280014",
    "rhuMAb HER2",
    "Trastuzumab Biosimilar ABP 980",
    "Trastuzumab Biosimilar PF-05280014"
  ],
  "description": "Given IV",
  "armGroupLabels": [
    "Arm II (WBI, trastuzumab)"
  ]
}
remove /protocolSection/armsInterventionsModule/interventions/3
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
{
  "name": "Laboratory Biomarker Analysis",
  "type": "OTHER",
  "description": "Correlative studies",
  "armGroupLabels": [
    "Arm I (standard WBI)",
    "Arm II (WBI, trastuzumab)"
  ]
}
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 4 ops
add /protocolSection/outcomesModule/secondaryOutcomes/0
Triage: High
Secondary Outcome Change Operation 14
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Contralateral breast cancer (invasive or DCIS)",
  "timeFrame": "Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer, assessed up to 10 years",
  "description": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions."
}
add /protocolSection/outcomesModule/secondaryOutcomes/1
Triage: High
Secondary Outcome Change Operation 15
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) in women who were premenopausal at the time of study entry",
  "timeFrame": "18 months",
  "description": "Amenorrhea will be summarized by treatment arm in terms of incidence rates and the ranges, medians, and quantiles of duration."
}
remove /protocolSection/outcomesModule/secondaryOutcomes/5
Triage: High
Secondary Outcome Change Operation 16
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Contralateral breast cancer (invasive or DCIS)",
  "timeFrame": "Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer, assessed up to 10 years",
  "description": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions."
}
remove /protocolSection/outcomesModule/secondaryOutcomes/6
Triage: High
Secondary Outcome Change Operation 17
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "measure": "Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) in women who were premenopausal at the time of study entry",
  "timeFrame": "18 months",
  "description": "Amenorrhea will be summarized by treatment arm in terms of incidence rates and the ranges, medians, and quantiles of duration."
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2015-04-08
After
2015-04-09
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2015-04-09
After
2015-04-10
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-04-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-04-10"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Other: Laboratory Biomarker Analysis"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/3"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/type",
    "value": "OTHER"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Laboratory Biomarker Analysis"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "Correlative studies"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels/0",
    "value": "Arm I (standard WBI)"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1",
    "value": {
      "name": "Trastuzumab",
      "type": "BIOLOGICAL",
      "otherNames": [
        "ABP 980",
        "Anti-c-ERB-2",
        "Anti-c-erbB2 Monoclonal Antibody",
        "Anti-ERB-2",
        "Anti-erbB-2",
        "Anti-erbB2 Monoclonal Antibody",
        "Anti-HER2/c-erbB2 Monoclonal Antibody",
        "Anti-p185-HER2",
        "c-erb-2 Monoclonal Antibody",
        "HER2 Monoclonal Antibody",
        "Herceptin",
        "Herceptin Biosimilar PF-05280014",
        "Herceptin Trastuzumab Biosimilar PF-05280014",
        "MoAb HER2",
        "Monoclonal Antibody c-erb-2",
        "Monoclonal Antibody HER2",
        "PF-05280014",
        "rhuMAb HER2",
        "Trastuzumab Biosimilar ABP 980",
        "Trastuzumab Biosimilar PF-05280014"
      ],
      "description": "Given IV",
      "armGroupLabels": [
        "Arm II (WBI, trastuzumab)"
      ]
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/3"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0",
    "value": {
      "measure": "Contralateral breast cancer (invasive or DCIS)",
      "timeFrame": "Time from randomization to first diagnosis of contralateral invasive or DCIS breast cancer, assessed up to 10 years",
      "description": "Cox proportional hazards models will be used to evaluate the effect of treatment on time to event.\nThe distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests.\nCompared across treatment arms using cumulative incidence functions."
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1",
    "value": {
      "measure": "Incidence of post-treatment amenorrhea (absence of menstrual period for at least 12 months) in women who were premenopausal at the time of study entry",
      "timeFrame": "18 months",
      "description": "Amenorrhea will be summarized by treatment arm in terms of incidence rates and the ranges, medians, and quantiles of duration."
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6"
  }
]