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NCT02384239

A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer

Version 5 to 6 · University of California, San Francisco

Patch inspector

Version 5 to 6

28 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/startDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ACTUAL",
    "old_type": null,
    "severity": "medium",
    "direction": "later",
    "new_value": "2015-11-04",
    "old_value": "2015-10",
    "delta_days": 34,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2020-12",
    "old_value": "2018-08",
    "delta_days": 853,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "medium",
    "direction": "later",
    "new_value": "2023-12",
    "old_value": "2020-08",
    "delta_days": 1217,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:57:34+00
Raw hash
5f61d2210dab3fc0ba01be998e375487303f995546f771c1e694971c975a2bca
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 9
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 4 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2015-10
After
2015-11-04
add /protocolSection/statusModule/startDateStruct/type
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
After
ACTUAL
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2018-08
After
2020-12
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2020-08
After
2023-12
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 19 ops
remove /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 10
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Hope S Rugo, MD",
    "role": "CONTACT",
    "email": "Hope.Rugo@ucsf.edu",
    "phone": "415 353-7618"
  },
  {
    "name": "Amy N DeLuca, B.S",
    "role": "CONTACT",
    "email": "Amy.DeLuca@ucsf.edu",
    "phone": "415-353-7288"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 11
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 12
Before
[
  {
    "name": "Amy DeLuca",
    "role": "CONTACT",
    "email": "Amy.DeLuca@ucsf.edu",
    "phone": "415-353-7288"
  },
  {
    "name": "Ivy Wong",
    "role": "CONTACT",
    "email": "Ivy.Wong@ucsf.edu",
    "phone": "415-353-7873"
  },
  {
    "name": "Hope Rugo, M.D.",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 13
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/1/contacts
Triage: Uncategorized
Uncategorized Operation 14
Before
[
  {
    "name": "Nellie Novielli",
    "role": "CONTACT",
    "email": "noviella@georgetown.edu",
    "phone": "202-784-3923"
  },
  {
    "name": "Julie Castle",
    "role": "CONTACT",
    "email": "bickmorj@georgetown.edu",
    "phone": "202-687-2209"
  },
  {
    "name": "Claudine Issacs, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/2/status
Triage: Uncategorized
Uncategorized Operation 15
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/2/contacts
Triage: Uncategorized
Uncategorized Operation 16
Before
[
  {
    "name": "Nana Owusu",
    "role": "CONTACT",
    "email": "nowusu@medicine.bsd.uchicago.edu",
    "phone": "773-702-2065"
  },
  {
    "name": "Glenna Smith",
    "role": "CONTACT",
    "email": "gsmith6@bsd.uchicago.edu",
    "phone": "773-834-2143"
  },
  {
    "name": "Rita Nanda, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/3/status
Triage: Uncategorized
Uncategorized Operation 17
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/3/contacts
Triage: Uncategorized
Uncategorized Operation 18
Before
[
  {
    "name": "Robbie Comito",
    "role": "CONTACT",
    "email": "rcomito@iupui.edu",
    "phone": "317-274-0935"
  },
  {
    "name": "Anna Maria Storniolo, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 19
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/4/contacts
Triage: Uncategorized
Uncategorized Operation 20
Before
[
  {
    "name": "Bridget Walsh",
    "role": "CONTACT",
    "email": "bwalsh9@jhmi.edu",
    "phone": "410-502-3613"
  },
  {
    "name": "Vered Stearns, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/5/status
Triage: Uncategorized
Uncategorized Operation 21
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/5/contacts
Triage: Uncategorized
Uncategorized Operation 22
Before
[
  {
    "name": "Lauren Fisher",
    "role": "CONTACT",
    "email": "lfisher7@partners.org",
    "phone": "617-632-4321"
  },
  {
    "name": "Nicole Ryabin",
    "role": "CONTACT",
    "email": "Nicole_Ryabin@dfci.harvard.edu",
    "phone": "617-632-6767"
  },
  {
    "name": "Erica Mayer, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/6/status
Triage: Uncategorized
Uncategorized Operation 23
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/6/contacts
Triage: Uncategorized
Uncategorized Operation 24
Before
[
  {
    "name": "Richelle Pelton",
    "role": "CONTACT",
    "email": "peltonr@med.umich.edu",
    "phone": "734-763-2960"
  },
  {
    "name": "Catherine Van Poznak, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/7/status
Triage: Uncategorized
Uncategorized Operation 25
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/7/contacts
Triage: Uncategorized
Uncategorized Operation 26
Before
[
  {
    "name": "Mikala Barnes",
    "role": "CONTACT",
    "email": "mikala.barnes@vanderbilt.edu",
    "phone": "615-875-0072"
  },
  {
    "name": "Kathleen Sanders",
    "role": "CONTACT",
    "email": "kathleen.sanders@Vanderbilt.Edu",
    "phone": "615-343-4091"
  },
  {
    "name": "Ingrid Mayer, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/8/status
Triage: Uncategorized
Uncategorized Operation 27
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/8/contacts
Triage: Uncategorized
Uncategorized Operation 28
Before
[
  {
    "name": "Claudette Foreman",
    "role": "CONTACT",
    "email": "claudette.foreman@bcm.edu",
    "phone": "713-798-7315"
  },
  {
    "name": "Anne Pavlick",
    "role": "CONTACT",
    "email": "anne.pavlick@bcm.edu",
    "phone": "713-798-7814"
  },
  {
    "name": "Polly Niravath, 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
2018-01
After
2019-03
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 7
Before
2018-01-23
After
2019-03-06
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 8
Before
2018-01-25
After
2019-03-08
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": "2019-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2015-11-04"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2020-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2023-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2019-03-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2019-03-08"
  },
  {
    "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"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/5/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/5/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/6/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/6/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/7/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/7/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/8/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/8/contacts"
  }
]