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NCT03393845

Study of Pembrolizumab Plus Fulvestrant in Hormone Receptor Positive, HER-2 Negative Advanced/Metastatic Breast Cancer Patients

Version 13 to 14 · Nancy Chan, MD

Patch inspector

Version 13 to 14

8 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
contact_admin_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": "2023-09-01",
    "old_value": "2023-01-01",
    "delta_days": 243,
    "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": "2024-09-01",
    "old_value": "2024-01-01",
    "delta_days": 244,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:01+00
Raw hash
b78db25e8430af751dbff2743e00318ad96656415204ed11e2b63c1d8e23290c
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 2
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2023-01-01
After
2023-09-01
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2024-01-01
After
2024-09-01
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 3 ops
replace /protocolSection/contactsLocationsModule/centralContacts/1/name
Triage: Low
Administrative Contact Change Operation 6
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
Kristi Wilmes
After
Rae Richards
replace /protocolSection/contactsLocationsModule/centralContacts/1/phoneExt
Triage: Low
Administrative Contact Change Operation 7
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
62
After
38
replace /protocolSection/contactsLocationsModule/centralContacts/1/email
Triage: Low
Administrative Contact Change Operation 8
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
kwilmes@hoosiercancer.org
After
rrichards@hoosiercancer.org
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
2022-09
After
2023-01
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2022-09-22
After
2023-01-18
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2022-09-23
After
2023-01-20
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-09-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2024-09-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-01-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-01-20"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/centralContacts/1/name",
    "value": "Rae Richards"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/centralContacts/1/phoneExt",
    "value": "38"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/centralContacts/1/email",
    "value": "rrichards@hoosiercancer.org"
  }
]