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NCT03393845

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

Version 9 to 10 · Nancy Chan, MD

Patch inspector

Version 9 to 10

12 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
contact_admin_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": "2023-01-01",
    "old_value": "2022-01-01",
    "delta_days": 365,
    "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": "2024-01-01",
    "old_value": "2023-01-01",
    "delta_days": 365,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:00+00
Raw hash
c7a11a5c290e1818fddb90e68e43b4c38714e02d43debb78907f5781c1ad71c6
Payload
Source URL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 3 ops
add /protocolSection/outcomesModule/secondaryOutcomes/1
Triage: High
Secondary Outcome Change Operation 6
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Progression free survival",
  "timeFrame": "36 months",
  "description": "Progression free survival is defined as the time from date of treatment start until the criteria for disease progression is met or death from any cause.\nPFS will be assessed by RECIST 1.1 and irRECIST"
}
add /protocolSection/outcomesModule/secondaryOutcomes/2
Triage: High
Secondary Outcome Change Operation 7
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Durable response rate",
  "timeFrame": "36 months",
  "description": "Durable response rate is defined as the number of months that a stable disease, partial or complete response is observed."
}
add /protocolSection/outcomesModule/secondaryOutcomes/3
Triage: High
Secondary Outcome Change Operation 8
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
{
  "measure": "Overall Survival",
  "timeFrame": "36 months",
  "description": "Overall survival is defined as defined as the time from date of treatment start until death"
}
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
2022-01-01
After
2023-01-01
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2023-01-01
After
2024-01-01
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 3 ops
replace /protocolSection/contactsLocationsModule/centralContacts/0/phone
Triage: Low
Administrative Contact Change Operation 10
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
1 732-235-9692
After
732-235-9692
replace /protocolSection/contactsLocationsModule/centralContacts/1/name
Triage: Low
Administrative Contact Change Operation 11
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
LeaEtta Hyer
After
Kristi Wilmes
replace /protocolSection/contactsLocationsModule/centralContacts/1/email
Triage: Low
Administrative Contact Change Operation 12
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
lhyer@hoosiercancer.org
After
kwilmes@hoosiercancer.org
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2021-12
After
2022-03
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2021-12-02
After
2022-03-22
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2021-12-17
After
2022-04-04
remove /protocolSection/outcomesModule/otherOutcomes
Triage: Uncategorized
Uncategorized Operation 9
Before
[
  {
    "measure": "Progression free survival",
    "timeFrame": "36 months",
    "description": "Progression free survival is defined as the time from date of treatment start until the criteria for disease progression is met or death from any cause.\nPFS will be assessed by RECIST 1.1 and irRECIST"
  },
  {
    "measure": "Durable response rate",
    "timeFrame": "36 months",
    "description": "Durable response rate is defined as the number of months that a stable disease, partial or complete response is observed."
  }
]
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2022-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-01-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2024-01-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2022-03-22"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2022-04-04"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1",
    "value": {
      "measure": "Progression free survival",
      "timeFrame": "36 months",
      "description": "Progression free survival is defined as the time from date of treatment start until the criteria for disease progression is met or death from any cause.\nPFS will be assessed by RECIST 1.1 and irRECIST"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2",
    "value": {
      "measure": "Durable response rate",
      "timeFrame": "36 months",
      "description": "Durable response rate is defined as the number of months that a stable disease, partial or complete response is observed."
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3",
    "value": {
      "measure": "Overall Survival",
      "timeFrame": "36 months",
      "description": "Overall survival is defined as defined as the time from date of treatment start until death"
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/otherOutcomes"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/centralContacts/0/phone",
    "value": "732-235-9692"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/centralContacts/1/name",
    "value": "Kristi Wilmes"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/centralContacts/1/email",
    "value": "kwilmes@hoosiercancer.org"
  }
]