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NCT03393845

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

Version 14 to 15 · Nancy Chan, MD

Patch inspector

Version 14 to 15

18 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
contact_admin_changeenrollment_type_change
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": "2023-06-26",
    "old_value": "2023-09-01",
    "delta_days": 67,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:13:01+00
Raw hash
c3beb581d694f395c14dd832f9377ff3012a927ad5f5808df4606d648813591d
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 1 ops
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 7
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 2 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
2023-09-01
After
2023-06-26
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
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 11 ops
remove /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 8
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Nancy Chan, MD",
    "role": "CONTACT",
    "email": "nancy.chan29@nyulangone.org",
    "phone": "732-235-9692"
  },
  {
    "name": "Rae Richards",
    "role": "CONTACT",
    "email": "rrichards@hoosiercancer.org",
    "phone": "317-634-5842",
    "phoneExt": "38"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 9
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 10
Before
[
  {
    "name": "Trinh Tran",
    "role": "CONTACT",
    "email": "trantrin@msu.edu",
    "phone": "517-975-9532"
  },
  {
    "name": "Marybeth Blythe",
    "role": "CONTACT",
    "email": "marybeth.blythe@hc.msu.edu",
    "phone": "517.975.9535"
  },
  {
    "name": "Jatin Rana, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 11
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/1/contacts
Triage: Uncategorized
Uncategorized Operation 12
Before
[
  {
    "name": "Eugene Sehi",
    "role": "CONTACT",
    "email": "esehi@unmc.edu",
    "phone": "402-559-8514"
  },
  {
    "name": "Pavankumar Tandra, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/2/status
Triage: Uncategorized
Uncategorized Operation 13
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/2/contacts
Triage: Uncategorized
Uncategorized Operation 14
Before
[
  {
    "name": "Nancy Chan, MD",
    "role": "CONTACT",
    "email": "nancy.chan29@nyulangone.org",
    "phone": "732-235-9692"
  },
  {
    "name": "Nancy Chan, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  },
  {
    "name": "Deborah Toppmeyer, MD",
    "role": "SUB_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/3/status
Triage: Uncategorized
Uncategorized Operation 15
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/3/contacts
Triage: Uncategorized
Uncategorized Operation 16
Before
[
  {
    "name": "Manju Rajan",
    "role": "CONTACT",
    "email": "pamela.rajan@nyulangone.org",
    "phone": "929-455-2435"
  },
  {
    "name": "Nancy Chan, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 17
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/4/contacts
Triage: Uncategorized
Uncategorized Operation 18
Before
[
  {
    "name": "Stephanie Yoo",
    "role": "CONTACT",
    "email": "yoo38@wisc.edu",
    "phone": "608-262-2572"
  },
  {
    "name": "Kari Wisinski, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
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
2023-01
After
2023-07
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2023-01-18
After
2023-07-03
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2023-01-20
After
2023-07-05
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
RECRUITING
After
ACTIVE_NOT_RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-06-26"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-07-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-07-05"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/centralContacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/1/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/2/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/2/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/3/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/3/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/4/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/4/contacts"
  }
]