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NCT02340221

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

Version 35 to 36 · Hoffmann-La Roche

Patch inspector

Version 35 to 36

26 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_actual_date_correction",
    "category": "timeline_actual_date_correction",
    "new_type": "ACTUAL",
    "old_type": "ACTUAL",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2015-04-08",
    "old_value": "2015-04-09",
    "delta_days": 1,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2018-06-30",
    "old_value": "2018-07-01",
    "delta_days": 1,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2018-06-30",
    "old_value": "2018-07-01",
    "delta_days": 1,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:51+00
Raw hash
cbb364bd64e08019c20f8df1d8d346ccde6b466070db6d12d77cc4a95a56fb38
Payload
Source URL
Timeline Start, primary completion, and completion date movement. Triage: Medium 3 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
2015-04-09
After
2015-04-08
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
2018-07-01
After
2018-06-30
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2018-07-01
After
2018-06-30
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 20 ops
replace /protocolSection/contactsLocationsModule/locations/44/status
Triage: Uncategorized
Uncategorized Operation 7
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/45/status
Triage: Uncategorized
Uncategorized Operation 8
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/56/status
Triage: Uncategorized
Uncategorized Operation 9
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/63/status
Triage: Uncategorized
Uncategorized Operation 10
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/69/status
Triage: Uncategorized
Uncategorized Operation 11
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/69/zip
Triage: Uncategorized
Uncategorized Operation 12
After
230002
replace /protocolSection/contactsLocationsModule/locations/103/status
Triage: Uncategorized
Uncategorized Operation 13
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/119/status
Triage: Uncategorized
Uncategorized Operation 14
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/122/status
Triage: Uncategorized
Uncategorized Operation 15
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/128/status
Triage: Uncategorized
Uncategorized Operation 16
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/137/facility
Triage: Uncategorized
Uncategorized Operation 17
Before
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddzial Chemioterapii
After
Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii
replace /protocolSection/contactsLocationsModule/locations/147/status
Triage: Uncategorized
Uncategorized Operation 18
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
add /protocolSection/contactsLocationsModule/locations/155
Triage: Uncategorized
Uncategorized Operation 19
After
{
  "zip": "197758",
  "city": "Saint Petersburg",
  "state": "Sankt-Peterburg",
  "status": "WITHDRAWN",
  "country": "Russia",
  "facility": "FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF",
  "geoPoint": {
    "lat": 59.93863,
    "lon": 30.31413
  }
}
remove /protocolSection/contactsLocationsModule/locations/160
Triage: Uncategorized
Uncategorized Operation 20
Before
{
  "zip": "197758",
  "city": "Saint Petersburg",
  "status": "WITHDRAWN",
  "country": "Russia",
  "facility": "FSBI Research Oncology Institute n.a. N.N.Petrov of Ministry of Health of Russian Federation",
  "geoPoint": {
    "lat": 59.93863,
    "lon": 30.31413
  }
}
replace /protocolSection/contactsLocationsModule/locations/161/status
Triage: Uncategorized
Uncategorized Operation 21
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/163/status
Triage: Uncategorized
Uncategorized Operation 22
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/169/status
Triage: Uncategorized
Uncategorized Operation 23
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/186/status
Triage: Uncategorized
Uncategorized Operation 24
Before
RECRUITING
After
ACTIVE_NOT_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/204/status
Triage: Uncategorized
Uncategorized Operation 25
Before
ACTIVE_NOT_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/207/facility
Triage: Uncategorized
Uncategorized Operation 26
Before
Acibadem University School of Medicine Kozyatagi Hospital Oncology Service
After
Acibadem University School of Medicine Altunizade Hospital Oncology Service
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
2017-05
After
2017-06
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2017-05-15
After
2017-06-14
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2017-05-16
After
2017-06-15
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2017-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2015-04-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2018-06-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2018-06-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2017-06-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2017-06-15"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/44/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/45/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/56/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/63/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/69/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/69/zip",
    "value": "230002"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/103/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/119/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/122/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/128/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/137/facility",
    "value": "Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/147/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/155",
    "value": {
      "zip": "197758",
      "city": "Saint Petersburg",
      "state": "Sankt-Peterburg",
      "status": "WITHDRAWN",
      "country": "Russia",
      "facility": "FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF",
      "geoPoint": {
        "lat": 59.93863,
        "lon": 30.31413
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/160"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/161/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/163/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/169/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/186/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/204/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/207/facility",
    "value": "Acibadem University School of Medicine Altunizade Hospital Oncology Service"
  }
]