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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 25 to 26 · Hoffmann-La Roche

Patch inspector

Version 25 to 26

34 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/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2024-11-20",
    "old_value": "2025-03-31",
    "delta_days": 131,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:04+00
Raw hash
bbdf07c7ed8eecd4a4d0883198b810b906cd0467c22b574568785bdee1c9cf85
Payload
Source URL
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2025-03-31
After
2024-11-20
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 26 ops
replace /protocolSection/contactsLocationsModule/locations/1/facility
Triage: Uncategorized
Uncategorized Operation 8
Before
Centro Oncologico Korben; Oncology
After
Centro Oncologico Korben
replace /protocolSection/contactsLocationsModule/locations/3/facility
Triage: Uncategorized
Uncategorized Operation 9
Before
Cantonal Hospital Zenica; Department for Oncology
After
Cantonal Hospital Zenica
replace /protocolSection/contactsLocationsModule/locations/4/zip
Triage: Uncategorized
Uncategorized Operation 10
Before
60336-232
After
60336-550
replace /protocolSection/contactsLocationsModule/locations/5/facility
Triage: Uncategorized
Uncategorized Operation 11
Before
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
After
Hospital Araujo Jorge
replace /protocolSection/contactsLocationsModule/locations/6/zip
Triage: Uncategorized
Uncategorized Operation 12
Before
90040-373
After
91350-200
replace /protocolSection/contactsLocationsModule/locations/8/facility
Triage: Uncategorized
Uncategorized Operation 13
Before
Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology
After
Multiprofile Hospital for Active Treatment Uni Hospital
remove /protocolSection/contactsLocationsModule/locations/16
Triage: Uncategorized
Uncategorized Operation 14
Before
{
  "zip": "7500653",
  "city": "Santiago",
  "country": "Chile",
  "facility": "Centro de Estudios Clínicos SAGA",
  "geoPoint": {
    "lat": -33.45694,
    "lon": -70.64827
  }
}
add /protocolSection/contactsLocationsModule/locations/17
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "city": "Santiago",
  "country": "Chile",
  "facility": "Centro de Estudios Clínicos SAGA",
  "geoPoint": {
    "lat": -33.45694,
    "lon": -70.64827
  }
}
replace /protocolSection/contactsLocationsModule/locations/20/facility
Triage: Uncategorized
Uncategorized Operation 16
Before
Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer
After
Hospital Metropolitano (Sede Lindora-Santa Ana)
replace /protocolSection/contactsLocationsModule/locations/23/facility
Triage: Uncategorized
Uncategorized Operation 17
Before
TATA Medical Centre; Medical Oncology
After
TATA Medical Centre
replace /protocolSection/contactsLocationsModule/locations/26/state
Triage: Uncategorized
Uncategorized Operation 18
Before
Mexico CITY (federal District)
After
Mexico City
replace /protocolSection/contactsLocationsModule/locations/27/state
Triage: Uncategorized
Uncategorized Operation 19
Before
Mexico CITY (federal District)
After
Mexico City
replace /protocolSection/contactsLocationsModule/locations/29/facility
Triage: Uncategorized
Uncategorized Operation 20
Before
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
After
Instituto Regional de Enfermedades Neoplásicas del Sur
replace /protocolSection/contactsLocationsModule/locations/30/facility
Triage: Uncategorized
Uncategorized Operation 21
Before
Oncocenter Peru S.A.C.; Oncosalud
After
Oncocenter Peru S.A.C.
replace /protocolSection/contactsLocationsModule/locations/31/facility
Triage: Uncategorized
Uncategorized Operation 22
Before
National Cancer Centre; Medical Oncology
After
National Cancer Centre
replace /protocolSection/contactsLocationsModule/locations/32/facility
Triage: Uncategorized
Uncategorized Operation 23
Before
Tan Tock Seng Hospital; Oncology
After
Tan Tock Seng Hospital
replace /protocolSection/contactsLocationsModule/locations/33/facility
Triage: Uncategorized
Uncategorized Operation 24
Before
Medical Oncology Centre of Rosebank; Oncology
After
Medical Oncology Centre of Rosebank
replace /protocolSection/contactsLocationsModule/locations/37/facility
Triage: Uncategorized
Uncategorized Operation 25
Before
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
After
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
add /protocolSection/contactsLocationsModule/locations/37/state
Triage: Uncategorized
Uncategorized Operation 26
After
JAEN
replace /protocolSection/contactsLocationsModule/locations/38/facility
Triage: Uncategorized
Uncategorized Operation 27
Before
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
After
Hospital Universitario Virgen de Arrixaca
add /protocolSection/contactsLocationsModule/locations/38/state
Triage: Uncategorized
Uncategorized Operation 28
After
Murcia
replace /protocolSection/contactsLocationsModule/locations/39/facility
Triage: Uncategorized
Uncategorized Operation 29
Before
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
After
Hospital Clinico Universitario de Salamanca
add /protocolSection/contactsLocationsModule/locations/39/state
Triage: Uncategorized
Uncategorized Operation 30
After
SALAMANCA
replace /protocolSection/contactsLocationsModule/locations/41/facility
Triage: Uncategorized
Uncategorized Operation 31
Before
Ankara City Hospital; Oncology
After
Ankara City Hospital
replace /protocolSection/contactsLocationsModule/locations/43/facility
Triage: Uncategorized
Uncategorized Operation 32
Before
Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology
After
Ba?c?lar Medipol Mega Üniversite Hastanesi
replace /protocolSection/contactsLocationsModule/locations/44/facility
Triage: Uncategorized
Uncategorized Operation 33
Before
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
After
Hacettepe Uni Medical Faculty Hospital
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2024-12
After
2025-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2024-12-20
After
2025-02-13
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2024-12-24
After
2025-02-17
replace /protocolSection/ipdSharingStatementModule/description
Triage: Uncategorized
Uncategorized Operation 34
Before
<p>For eligible studies, qualified researchers may request access to individual patient level data through the request platform (www.vivli.org).
Further details on Roche&#x27;s criteria for eligible studies are available here (https:&#x2F;&#x2F;vivli.org&#x2F;ourmember&#x2F;roche&#x2F;).</p><p>For further details on Roche&#x27;s Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https:&#x2F;&#x2F;www.roche.com&#x2F;innovation&#x2F;process&#x2F;clinical-trials&#x2F;data-sharing&#x2F;).</p>
After
For eligible studies, qualified researchers may request access to individual patient level clinical data.
See Roche&#x27;s commitment to transparency of clinical study information here: https:&#x2F;&#x2F;go.roche.com&#x2F;data_sharing
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 2 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
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&#x2F;Inflammatory HER2-Positive Breast Cancer
After
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&#x2F;Inflammatory HER2-Positive Breast Cancer
replace /protocolSection/identificationModule/officialTitle
Triage: Uncategorized
Uncategorized Operation 2
Before
A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label 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&#x2F;Inflammatory HER2-Positive Breast Cancer
After
A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label 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&#x2F;Inflammatory HER2-Positive Breast Cancer
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "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&#x2F;Inflammatory HER2-Positive Breast Cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/officialTitle",
    "value": "A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label 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&#x2F;Inflammatory HER2-Positive Breast Cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2025-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2024-11-20"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-02-13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2025-02-17"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/facility",
    "value": "Centro Oncologico Korben"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/facility",
    "value": "Cantonal Hospital Zenica"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/zip",
    "value": "60336-550"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/facility",
    "value": "Hospital Araujo Jorge"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/zip",
    "value": "91350-200"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/facility",
    "value": "Multiprofile Hospital for Active Treatment Uni Hospital"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/16"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/17",
    "value": {
      "city": "Santiago",
      "country": "Chile",
      "facility": "Centro de Estudios Clínicos SAGA",
      "geoPoint": {
        "lat": -33.45694,
        "lon": -70.64827
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/20/facility",
    "value": "Hospital Metropolitano (Sede Lindora-Santa Ana)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/23/facility",
    "value": "TATA Medical Centre"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/26/state",
    "value": "Mexico City"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/27/state",
    "value": "Mexico City"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/29/facility",
    "value": "Instituto Regional de Enfermedades Neoplásicas del Sur"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/30/facility",
    "value": "Oncocenter Peru S.A.C."
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/31/facility",
    "value": "National Cancer Centre"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/32/facility",
    "value": "Tan Tock Seng Hospital"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/33/facility",
    "value": "Medical Oncology Centre of Rosebank"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/37/facility",
    "value": "Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/37/state",
    "value": "JAEN"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/38/facility",
    "value": "Hospital Universitario Virgen de Arrixaca"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/38/state",
    "value": "Murcia"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/39/facility",
    "value": "Hospital Clinico Universitario de Salamanca"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/39/state",
    "value": "SALAMANCA"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/41/facility",
    "value": "Ankara City Hospital"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/43/facility",
    "value": "Ba?c?lar Medipol Mega Üniversite Hastanesi"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/44/facility",
    "value": "Hacettepe Uni Medical Faculty Hospital"
  },
  {
    "op": "replace",
    "path": "/protocolSection/ipdSharingStatementModule/description",
    "value": "For eligible studies, qualified researchers may request access to individual patient level clinical data.\nSee Roche&#x27;s commitment to transparency of clinical study information here: https:&#x2F;&#x2F;go.roche.com&#x2F;data_sharing"
  }
]