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NCT04224272

A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

Version 13 to 14 · Jazz Pharmaceuticals

Patch inspector

Version 13 to 14

11 operations 5 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
enrollment_count_changeenrollment_type_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_significant_shift",
    "category": "timeline_significant_shift",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2023-04-28",
    "old_value": "2022-12-30",
    "delta_days": 119,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "high",
    "direction": "later",
    "new_value": "2025-10-26",
    "old_value": "2023-06-30",
    "delta_days": 849,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 51,
    "old_value": 86,
    "pct_change": 0.407
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:08+00
Raw hash
ca1540e9a2bbfb52fd7e57d8ecf21b616a6168428fe2a4183316ce903e5da09c
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 9
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
86
After
51
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 10
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
Timeline Start, primary completion, and completion date movement. Triage: Medium 3 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
2022-12-30
After
2023-04-28
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2023-06-30
After
2025-10-26
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 1 ops
remove /protocolSection/contactsLocationsModule/overallOfficials
Triage: Uncategorized
Uncategorized Operation 11
Before
[
  {
    "name": "Elaina Gartner, MD",
    "role": "STUDY_DIRECTOR",
    "affiliation": "Zymeworks BC Inc."
  }
]
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
2022-11
After
2023-08
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 6
Before
2022-11-17
After
2023-08-11
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 7
Before
2022-11-21
After
2023-08-15
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 2 ops
replace /protocolSection/identificationModule/organization/fullName
Triage: Uncategorized
Uncategorized Operation 1
Before
Zymeworks BC Inc.
After
Jazz Pharmaceuticals
replace /protocolSection/sponsorCollaboratorsModule/leadSponsor/name
Triage: Uncategorized
Uncategorized Operation 8
Before
Zymeworks BC Inc.
After
Jazz Pharmaceuticals
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/organization/fullName",
    "value": "Jazz Pharmaceuticals"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-04-28"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2025-10-26"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-08-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-08-15"
  },
  {
    "op": "replace",
    "path": "/protocolSection/sponsorCollaboratorsModule/leadSponsor/name",
    "value": "Jazz Pharmaceuticals"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 51
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/overallOfficials"
  }
]