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NCT03584009

A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Version 3 to 4 · Hoffmann-La Roche

Patch inspector

Version 3 to 4

32 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

None recorded.

Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2018-09-06",
    "old_value": "2018-09-13",
    "delta_days": 7,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "signal": "milestone_realized",
    "category": "milestone_realized",
    "new_date": "2018-09-06",
    "new_type": "ACTUAL",
    "old_date": "2018-09-13",
    "old_type": "ESTIMATED",
    "severity": "low",
    "delta_days": 7,
    "date_struct": "startDateStruct"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:47+00
Raw hash
c395b1e7c6f3db4efc1342902c776cfdef8772db71ddd5de0491d1c89ba88931
Payload
Source URL
Timeline Start, primary completion, and completion date movement. Triage: Medium 2 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2018-09-13
After
2018-09-06
replace /protocolSection/statusModule/startDateStruct/type
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 27 ops
replace /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 6
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/1/status
Triage: Uncategorized
Uncategorized Operation 7
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/3/status
Triage: Uncategorized
Uncategorized Operation 8
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/5/status
Triage: Uncategorized
Uncategorized Operation 9
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/6/status
Triage: Uncategorized
Uncategorized Operation 10
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/8/status
Triage: Uncategorized
Uncategorized Operation 11
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/10/facility
Triage: Uncategorized
Uncategorized Operation 12
Before
Massachusetts General Hospital.
After
North Shore Cancer Center
replace /protocolSection/contactsLocationsModule/locations/10/status
Triage: Uncategorized
Uncategorized Operation 13
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/10/zip
Triage: Uncategorized
Uncategorized Operation 14
Before
02114
After
01923
add /protocolSection/contactsLocationsModule/locations/11
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "zip": "02114",
  "city": "Boston",
  "state": "Massachusetts",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "Massachusetts General Hospital.",
  "geoPoint": {
    "lat": 42.35843,
    "lon": -71.05977
  }
}
replace /protocolSection/contactsLocationsModule/locations/14/status
Triage: Uncategorized
Uncategorized Operation 16
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/16/status
Triage: Uncategorized
Uncategorized Operation 17
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/17/status
Triage: Uncategorized
Uncategorized Operation 18
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/18/status
Triage: Uncategorized
Uncategorized Operation 19
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/20/status
Triage: Uncategorized
Uncategorized Operation 20
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/21/status
Triage: Uncategorized
Uncategorized Operation 21
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/22/facility
Triage: Uncategorized
Uncategorized Operation 22
Before
Mater Adult Hospital
After
Mater Misericordiae Limited
replace /protocolSection/contactsLocationsModule/locations/22/status
Triage: Uncategorized
Uncategorized Operation 23
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/24/status
Triage: Uncategorized
Uncategorized Operation 24
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/25/status
Triage: Uncategorized
Uncategorized Operation 25
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/26/status
Triage: Uncategorized
Uncategorized Operation 26
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/27/status
Triage: Uncategorized
Uncategorized Operation 27
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/38/status
Triage: Uncategorized
Uncategorized Operation 28
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/39/status
Triage: Uncategorized
Uncategorized Operation 29
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/40/status
Triage: Uncategorized
Uncategorized Operation 30
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/41/status
Triage: Uncategorized
Uncategorized Operation 31
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/42/status
Triage: Uncategorized
Uncategorized Operation 32
Before
NOT_YET_RECRUITING
After
RECRUITING
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
2018-08
After
2019-02
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2018-08-24
After
2019-02-07
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2018-08-27
After
2019-02-08
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2019-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2018-09-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2019-02-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2019-02-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/3/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/6/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/8/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/facility",
    "value": "North Shore Cancer Center"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/10/zip",
    "value": "01923"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/11",
    "value": {
      "zip": "02114",
      "city": "Boston",
      "state": "Massachusetts",
      "status": "RECRUITING",
      "country": "United States",
      "facility": "Massachusetts General Hospital.",
      "geoPoint": {
        "lat": 42.35843,
        "lon": -71.05977
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/14/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/16/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/17/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/18/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/20/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/21/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/22/facility",
    "value": "Mater Misericordiae Limited"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/22/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/24/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/25/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/26/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/27/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/38/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/39/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/40/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/41/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/42/status",
    "value": "RECRUITING"
  }
]