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NCT03414684

Carboplatin +/- Nivolumab in Metastatic Triple Negative Breast Cancer

Version 9 to 10 · Dana-Farber Cancer Institute

Patch inspector

Version 9 to 10

29 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_changeenrollment_count_changeenrollment_type_change
Value signals
[
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 78,
    "old_value": 132,
    "pct_change": 0.4091
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:21+00
Raw hash
125b245078b5c2802db34b3b07ff151542fe6d12e7e956cf4e078a340c3c30c6
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 5
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
132
After
78
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 6
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 23 ops
remove /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 7
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
Before
[
  {
    "name": "Paulina Lange",
    "role": "CONTACT",
    "email": "paulinab_lange@dfci.harvard.edu",
    "phone": "617-632-2257"
  }
]
remove /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 8
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/0/contacts
Triage: Uncategorized
Uncategorized Operation 9
Before
[
  {
    "name": "K.M. Steve Lo, MD",
    "role": "CONTACT",
    "email": "SLo@stamhealth.org"
  },
  {
    "name": "K.M. Steve Lo, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 10
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/1/contacts
Triage: Uncategorized
Uncategorized Operation 11
Before
[
  {
    "name": "Zarah F Lucas, MD",
    "role": "CONTACT",
    "email": "zdlucas@emhs.org"
  },
  {
    "name": "Zarah F Lucas, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/2/status
Triage: Uncategorized
Uncategorized Operation 12
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/2/contacts
Triage: Uncategorized
Uncategorized Operation 13
Before
[
  {
    "name": "Nadine Tung, MD",
    "role": "CONTACT",
    "email": "ntung@bidmc.harvard.edu"
  },
  {
    "name": "Nadine Tung, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/3/status
Triage: Uncategorized
Uncategorized Operation 14
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/3/contacts
Triage: Uncategorized
Uncategorized Operation 15
Before
[
  {
    "name": "Cassidy Elizabeth Kelley",
    "role": "CONTACT",
    "email": "ckelley14@partners.org",
    "phone": "617-632-3548"
  },
  {
    "name": "Sara Tolaney, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 16
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/4/contacts
Triage: Uncategorized
Uncategorized Operation 17
Before
[
  {
    "name": "caroline Block, MD",
    "role": "CONTACT",
    "email": "caroline_block@dfci.harvard.edu"
  },
  {
    "name": "Caroline Block, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/5/status
Triage: Uncategorized
Uncategorized Operation 18
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/5/contacts
Triage: Uncategorized
Uncategorized Operation 19
Before
[
  {
    "name": "Natalie Sinclair, MD",
    "role": "CONTACT",
    "email": "nsinclair1@partners.org"
  },
  {
    "name": "Natalie Sinclair, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/6/status
Triage: Uncategorized
Uncategorized Operation 20
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/6/contacts
Triage: Uncategorized
Uncategorized Operation 21
Before
[
  {
    "name": "Dorcas Chi, MD",
    "role": "CONTACT",
    "email": "dorcas_chi@dfci.harvard.edu"
  },
  {
    "name": "Dorcas Chi, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/7/status
Triage: Uncategorized
Uncategorized Operation 22
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/7/contacts
Triage: Uncategorized
Uncategorized Operation 23
Before
[
  {
    "name": "Madhavi Toke, MD",
    "role": "CONTACT",
    "email": "tokem@umassmemorial.org"
  }
]
remove /protocolSection/contactsLocationsModule/locations/8/status
Triage: Uncategorized
Uncategorized Operation 24
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/8/contacts
Triage: Uncategorized
Uncategorized Operation 25
Before
[
  {
    "name": "Fred Briccetti, MD",
    "role": "CONTACT",
    "email": "fred_briccetti@dfci.harvard.edu"
  },
  {
    "name": "Fred Briccetti, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/9/status
Triage: Uncategorized
Uncategorized Operation 26
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/9/contacts
Triage: Uncategorized
Uncategorized Operation 27
Before
[
  {
    "name": "Robert Wesolowski, MD",
    "role": "CONTACT",
    "email": "robert.wesolowski@osumc.edu"
  },
  {
    "name": "Robert Wesolowski, MD",
    "role": "PRINCIPAL_INVESTIGATOR"
  }
]
remove /protocolSection/contactsLocationsModule/locations/10/status
Triage: Uncategorized
Uncategorized Operation 28
Before
RECRUITING
remove /protocolSection/contactsLocationsModule/locations/10/contacts
Triage: Uncategorized
Uncategorized Operation 29
Before
[
  {
    "name": "Peter Kaufman, MD",
    "role": "CONTACT",
    "email": "peter.kaufman@uvmhealth.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
2020-11
After
2020-12
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2020-11-09
After
2020-12-14
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2020-11-10
After
2020-12-16
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": "2020-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2020-12-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2020-12-16"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 78
  },
  {
    "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"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/9/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/9/contacts"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/10/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/10/contacts"
  }
]