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NCT05415215

A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

Version 20 to 21 · Hoffmann-La Roche

Patch inspector

Version 20 to 21

13 operations 6 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_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2025-03-31",
    "old_value": "2024-08-05",
    "delta_days": 238,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "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": "2025-12-31",
    "old_value": "2025-09-25",
    "delta_days": 97,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:03+00
Raw hash
6c99d95ff72ab7f6e03d5b0177a50ee67831ac36a266c5fff149d63d4abb8fbf
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 5 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
346
After
347
replace /protocolSection/armsInterventionsModule/interventions/0/otherNames/0
Triage: High
Arm Intervention Change Operation 8
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
PHESGO
After
PHESGO®
replace /protocolSection/armsInterventionsModule/interventions/1/otherNames/0
Triage: High
Arm Intervention Change Operation 9
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Perjeta
After
Perjeta®
replace /protocolSection/armsInterventionsModule/interventions/2/otherNames/0
Triage: High
Arm Intervention Change Operation 10
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Herceptin
After
Herceptin®
replace /protocolSection/armsInterventionsModule/interventions/3/otherNames/0
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
Before
Kadcyla
After
Kadcyla®
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
add /protocolSection/outcomesModule/secondaryOutcomes/18
Triage: High
Secondary Outcome Change Operation 12
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Percentage of Participants who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period",
  "timeFrame": "Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)"
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2024-08-05
After
2025-03-31
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2025-09-25
After
2025-12-31
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 1 ops
replace /protocolSection/contactsLocationsModule/locations/6/zip
Triage: Uncategorized
Uncategorized Operation 13
Before
91350-200
After
90040-373
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2024-01
After
2024-03
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2024-01-18
After
2024-03-18
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2024-01-19
After
2024-03-19
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
add /protocolSection/identificationModule/secondaryIdInfos/1
Triage: Uncategorized
Uncategorized Operation 1
After
{
  "id": "2023-506380-33-00",
  "type": "REGISTRY",
  "domain": "EU CT Number"
}
Raw JSON Patch 
[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos/1",
    "value": {
      "id": "2023-506380-33-00",
      "type": "REGISTRY",
      "domain": "EU CT Number"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2024-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2025-03-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2025-12-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2024-03-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2024-03-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 347
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
    "value": "PHESGO®"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/1/otherNames/0",
    "value": "Perjeta®"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/2/otherNames/0",
    "value": "Herceptin®"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/3/otherNames/0",
    "value": "Kadcyla®"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/18",
    "value": {
      "measure": "Percentage of Participants who Selected the Administration of PH FDC SC in the Home Setting Compared With the Hospital Setting in the Treatment Continuation Period",
      "timeFrame": "Day 1 of Cycle 8 of adjuvant treatment (1 cycle is 3 weeks)"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/zip",
    "value": "90040-373"
  }
]