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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 0 to 1 · Hoffmann-La Roche

Patch inspector

Version 0 to 1

7 operations 4 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

None recorded.

Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2022-07-05",
    "old_value": "2022-07-29",
    "delta_days": 24,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "signal": "milestone_realized",
    "category": "milestone_realized",
    "new_date": "2022-07-05",
    "new_type": "ACTUAL",
    "old_date": "2022-07-29",
    "old_type": "ESTIMATED",
    "severity": "low",
    "delta_days": 24,
    "date_struct": "startDateStruct"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:58+00
Raw hash
512662c6dff1af1c8cb9967534cd9c02dc8fd43ee74eee061ba396e46667eade
Payload
Source URL
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2022-07-29
After
2022-07-05
replace /protocolSection/statusModule/startDateStruct/type
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 1 ops
add /protocolSection/contactsLocationsModule/locations
Triage: Uncategorized
Uncategorized Operation 7
After
[
  {
    "zip": "G1S 4L8",
    "city": "Québec",
    "state": "Quebec",
    "status": "RECRUITING",
    "country": "Canada",
    "facility": "Hopital du Saint Sacrement",
    "geoPoint": {
      "lat": 46.81228,
      "lon": -71.21454
    }
  },
  {
    "zip": "03100",
    "city": "Mexico City",
    "state": "Mexico CITY (federal District)",
    "status": "RECRUITING",
    "country": "Mexico",
    "facility": "Health Pharma Professional Research",
    "geoPoint": {
      "lat": 19.42847,
      "lon": -99.12766
    }
  },
  {
    "zip": "04980",
    "city": "D.F.",
    "status": "RECRUITING",
    "country": "Mexico",
    "facility": "Iem-Fucam"
  },
  {
    "zip": "30120",
    "city": "Murcia",
    "status": "RECRUITING",
    "country": "Spain",
    "facility": "Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia",
    "geoPoint": {
      "lat": 37.98704,
      "lon": -1.13004
    }
  }
]
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
2022-06
After
2022-07
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2022-06-08
After
2022-07-06
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2022-06-13
After
2022-07-07
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 2
Before
NOT_YET_RECRUITING
After
RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2022-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2022-07-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2022-07-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2022-07-07"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations",
    "value": [
      {
        "zip": "G1S 4L8",
        "city": "Québec",
        "state": "Quebec",
        "status": "RECRUITING",
        "country": "Canada",
        "facility": "Hopital du Saint Sacrement",
        "geoPoint": {
          "lat": 46.81228,
          "lon": -71.21454
        }
      },
      {
        "zip": "03100",
        "city": "Mexico City",
        "state": "Mexico CITY (federal District)",
        "status": "RECRUITING",
        "country": "Mexico",
        "facility": "Health Pharma Professional Research",
        "geoPoint": {
          "lat": 19.42847,
          "lon": -99.12766
        }
      },
      {
        "zip": "04980",
        "city": "D.F.",
        "status": "RECRUITING",
        "country": "Mexico",
        "facility": "Iem-Fucam"
      },
      {
        "zip": "30120",
        "city": "Murcia",
        "status": "RECRUITING",
        "country": "Spain",
        "facility": "Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia",
        "geoPoint": {
          "lat": 37.98704,
          "lon": -1.13004
        }
      }
    ]
  }
]