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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 10 to 11 · Hoffmann-La Roche

Patch inspector

Version 10 to 11

77 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
secondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": null,
    "old_type": null,
    "severity": "medium",
    "direction": "later",
    "new_value": "2015-04",
    "old_value": "2015-01",
    "delta_days": 90,
    "date_struct": "startDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:44+00
Raw hash
dbb0eda938aed87700f0e74262b035ef1844d92a760614f83307ce3233cd1f0a
Payload
Source URL
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 1 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/1/measure
Triage: High
Secondary Outcome Change Operation 5
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall objective response (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1
After
Overall objective response rate (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 1
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2015-01
After
2015-04
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 72 ops
replace /protocolSection/contactsLocationsModule/locations/0/status
Triage: Uncategorized
Uncategorized Operation 6
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 7
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/5/status
Triage: Uncategorized
Uncategorized Operation 8
Before
NOT_YET_RECRUITING
After
RECRUITING
replace /protocolSection/contactsLocationsModule/locations/5/city
Triage: Uncategorized
Uncategorized Operation 9
Before
Rockville
After
Westminster
replace /protocolSection/contactsLocationsModule/locations/5/zip
Triage: Uncategorized
Uncategorized Operation 10
Before
20850
After
21157
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 11
Before
39.084
After
39.57538
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 12
Before
-77.15276
After
-76.99581
add /protocolSection/contactsLocationsModule/locations/7
Triage: Uncategorized
Uncategorized Operation 13
After
{
  "zip": "63011",
  "city": "Ballwin",
  "state": "Missouri",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 38.59505,
    "lon": -90.54623
  }
}
add /protocolSection/contactsLocationsModule/locations/8
Triage: Uncategorized
Uncategorized Operation 14
After
{
  "zip": "63109",
  "city": "St Louis",
  "state": "Missouri",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 38.62727,
    "lon": -90.19789
  }
}
add /protocolSection/contactsLocationsModule/locations/10
Triage: Uncategorized
Uncategorized Operation 15
After
{
  "zip": "07920",
  "city": "Basking Ridge",
  "state": "New Jersey",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 40.70621,
    "lon": -74.54932
  }
}
add /protocolSection/contactsLocationsModule/locations/11
Triage: Uncategorized
Uncategorized Operation 16
After
{
  "zip": "11725",
  "city": "Commack",
  "state": "New York",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 40.84288,
    "lon": -73.29289
  }
}
add /protocolSection/contactsLocationsModule/locations/12
Triage: Uncategorized
Uncategorized Operation 17
After
{
  "zip": "10604",
  "city": "East White Plains",
  "state": "New York",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 41.03899,
    "lon": -73.74763
  }
}
add /protocolSection/contactsLocationsModule/locations/14
Triage: Uncategorized
Uncategorized Operation 18
After
{
  "zip": "11570",
  "city": "Rockville Centre",
  "state": "New York",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 40.65871,
    "lon": -73.64124
  }
}
add /protocolSection/contactsLocationsModule/locations/15
Triage: Uncategorized
Uncategorized Operation 19
After
{
  "zip": "10591",
  "city": "Sleepy Hollow",
  "state": "New York",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 41.08565,
    "lon": -73.85847
  }
}
remove /protocolSection/contactsLocationsModule/locations/20
Triage: Uncategorized
Uncategorized Operation 20
Before
{
  "zip": "3011",
  "city": "Footscray",
  "state": "Victoria",
  "status": "NOT_YET_RECRUITING",
  "country": "Australia",
  "geoPoint": {
    "lat": -37.8,
    "lon": 144.9
  }
}
add /protocolSection/contactsLocationsModule/locations/21
Triage: Uncategorized
Uncategorized Operation 21
After
{
  "zip": "3021",
  "city": "St Albans",
  "state": "Victoria",
  "status": "RECRUITING",
  "country": "Australia",
  "geoPoint": {
    "lat": -37.74496,
    "lon": 144.80049
  }
}
add /protocolSection/contactsLocationsModule/locations/27
Triage: Uncategorized
Uncategorized Operation 22
After
{
  "zip": "4004",
  "city": "Plovdiv",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 42.15387,
    "lon": 24.75001
  }
}
add /protocolSection/contactsLocationsModule/locations/28
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "zip": "1330",
  "city": "Sofia",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 42.69751,
    "lon": 23.32415
  }
}
add /protocolSection/contactsLocationsModule/locations/29
Triage: Uncategorized
Uncategorized Operation 24
After
{
  "zip": "1756",
  "city": "Sofia",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 42.69751,
    "lon": 23.32415
  }
}
add /protocolSection/contactsLocationsModule/locations/30
Triage: Uncategorized
Uncategorized Operation 25
After
{
  "zip": "9010",
  "city": "Varna",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 43.21912,
    "lon": 27.91024
  }
}
add /protocolSection/contactsLocationsModule/locations/33
Triage: Uncategorized
Uncategorized Operation 26
After
{
  "zip": "N2G 1G3",
  "city": "Kitchener",
  "state": "Ontario",
  "status": "RECRUITING",
  "country": "Canada",
  "geoPoint": {
    "lat": 43.42537,
    "lon": -80.5112
  }
}
replace /protocolSection/contactsLocationsModule/locations/36/zip
Triage: Uncategorized
Uncategorized Operation 27
Before
H2W 1T8
After
H2X 0A9
add /protocolSection/contactsLocationsModule/locations/37
Triage: Uncategorized
Uncategorized Operation 28
After
{
  "zip": "H3T 1E2",
  "city": "Montreal",
  "state": "Quebec",
  "status": "RECRUITING",
  "country": "Canada",
  "geoPoint": {
    "lat": 45.50884,
    "lon": -73.58781
  }
}
add /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 29
After
{
  "zip": "QC G1S 4L8",
  "city": "Québec",
  "state": "Quebec",
  "status": "NOT_YET_RECRUITING",
  "country": "Canada",
  "geoPoint": {
    "lat": 46.81228,
    "lon": -71.21454
  }
}
add /protocolSection/contactsLocationsModule/locations/39
Triage: Uncategorized
Uncategorized Operation 30
After
{
  "zip": "500 05",
  "city": "Hradec Králové",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 50.20923,
    "lon": 15.83277
  }
}
add /protocolSection/contactsLocationsModule/locations/40
Triage: Uncategorized
Uncategorized Operation 31
After
{
  "zip": "775 20",
  "city": "Olomouc",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 49.59552,
    "lon": 17.25175
  }
}
add /protocolSection/contactsLocationsModule/locations/41
Triage: Uncategorized
Uncategorized Operation 32
After
{
  "zip": "532 03",
  "city": "Pardubice",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 50.04075,
    "lon": 15.77659
  }
}
add /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 33
After
{
  "zip": "128 08",
  "city": "Prague",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 50.08804,
    "lon": 14.42076
  }
}
add /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 34
After
{
  "zip": "87042",
  "city": "Limoges",
  "status": "NOT_YET_RECRUITING",
  "country": "France",
  "geoPoint": {
    "lat": 45.83362,
    "lon": 1.24759
  }
}
add /protocolSection/contactsLocationsModule/locations/54
Triage: Uncategorized
Uncategorized Operation 35
After
{
  "zip": "10367",
  "city": "Berlin",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/55
Triage: Uncategorized
Uncategorized Operation 36
After
{
  "zip": "10707",
  "city": "Berlin",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "geoPoint": {
    "lat": 52.52437,
    "lon": 13.41053
  }
}
add /protocolSection/contactsLocationsModule/locations/56
Triage: Uncategorized
Uncategorized Operation 37
After
{
  "zip": "45122",
  "city": "Essen",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "geoPoint": {
    "lat": 51.45657,
    "lon": 7.01228
  }
}
add /protocolSection/contactsLocationsModule/locations/57
Triage: Uncategorized
Uncategorized Operation 38
After
{
  "zip": "36043",
  "city": "Fulda",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "geoPoint": {
    "lat": 50.55162,
    "lon": 9.67518
  }
}
add /protocolSection/contactsLocationsModule/locations/58
Triage: Uncategorized
Uncategorized Operation 39
After
{
  "zip": "20357",
  "city": "Hamburg",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "geoPoint": {
    "lat": 53.55073,
    "lon": 9.99302
  }
}
add /protocolSection/contactsLocationsModule/locations/59
Triage: Uncategorized
Uncategorized Operation 40
After
{
  "zip": "30559",
  "city": "Hanover",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "geoPoint": {
    "lat": 52.37052,
    "lon": 9.73322
  }
}
add /protocolSection/contactsLocationsModule/locations/60
Triage: Uncategorized
Uncategorized Operation 41
After
{
  "zip": "54290",
  "city": "Trier",
  "status": "NOT_YET_RECRUITING",
  "country": "Germany",
  "geoPoint": {
    "lat": 49.75565,
    "lon": 6.63935
  }
}
add /protocolSection/contactsLocationsModule/locations/61
Triage: Uncategorized
Uncategorized Operation 42
After
{
  "zip": "80131",
  "city": "Naples",
  "state": "Campania",
  "status": "RECRUITING",
  "country": "Italy",
  "geoPoint": {
    "lat": 40.85216,
    "lon": 14.26811
  }
}
add /protocolSection/contactsLocationsModule/locations/62
Triage: Uncategorized
Uncategorized Operation 43
After
{
  "zip": "20141",
  "city": "Milan",
  "state": "Lombardy",
  "status": "RECRUITING",
  "country": "Italy",
  "geoPoint": {
    "lat": 45.46427,
    "lon": 9.18951
  }
}
add /protocolSection/contactsLocationsModule/locations/66
Triage: Uncategorized
Uncategorized Operation 44
After
{
  "zip": "34",
  "city": "Lima",
  "status": "NOT_YET_RECRUITING",
  "country": "Peru",
  "geoPoint": {
    "lat": -12.04318,
    "lon": -77.02824
  }
}
add /protocolSection/contactsLocationsModule/locations/67
Triage: Uncategorized
Uncategorized Operation 45
After
{
  "zip": "15-027",
  "city": "Bialystok",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.13333,
    "lon": 23.16433
  }
}
add /protocolSection/contactsLocationsModule/locations/68
Triage: Uncategorized
Uncategorized Operation 46
After
{
  "zip": "85-796",
  "city": "Bydgoszcz",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.1235,
    "lon": 18.00762
  }
}
add /protocolSection/contactsLocationsModule/locations/69
Triage: Uncategorized
Uncategorized Operation 47
After
{
  "zip": "80-952",
  "city": "Gdansk",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 54.35227,
    "lon": 18.64912
  }
}
add /protocolSection/contactsLocationsModule/locations/70
Triage: Uncategorized
Uncategorized Operation 48
After
{
  "zip": "62-500",
  "city": "Konin",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 52.22338,
    "lon": 18.25121
  }
}
add /protocolSection/contactsLocationsModule/locations/71
Triage: Uncategorized
Uncategorized Operation 49
After
{
  "zip": "31-531",
  "city": "Krakow",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 50.06143,
    "lon": 19.93658
  }
}
add /protocolSection/contactsLocationsModule/locations/72
Triage: Uncategorized
Uncategorized Operation 50
After
{
  "zip": "93-513",
  "city": "Lodz",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 51.77058,
    "lon": 19.47395
  }
}
add /protocolSection/contactsLocationsModule/locations/73
Triage: Uncategorized
Uncategorized Operation 51
After
{
  "zip": "20-090",
  "city": "Lublin",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 51.25058,
    "lon": 22.57009
  }
}
add /protocolSection/contactsLocationsModule/locations/74
Triage: Uncategorized
Uncategorized Operation 52
After
{
  "zip": "71-730",
  "city": "Szczecin",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.42894,
    "lon": 14.55302
  }
}
add /protocolSection/contactsLocationsModule/locations/75
Triage: Uncategorized
Uncategorized Operation 53
After
{
  "zip": "87-100",
  "city": "Torun",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.01375,
    "lon": 18.59814
  }
}
add /protocolSection/contactsLocationsModule/locations/80
Triage: Uncategorized
Uncategorized Operation 54
After
{
  "zip": "022328",
  "city": "Bucharest",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 44.43225,
    "lon": 26.10626
  }
}
add /protocolSection/contactsLocationsModule/locations/81
Triage: Uncategorized
Uncategorized Operation 55
After
{
  "zip": "400015",
  "city": "Cluj-Napoca",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 46.76667,
    "lon": 23.6
  }
}
add /protocolSection/contactsLocationsModule/locations/82
Triage: Uncategorized
Uncategorized Operation 56
After
{
  "zip": "400349",
  "city": "Cluj-Napoca",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 46.76667,
    "lon": 23.6
  }
}
add /protocolSection/contactsLocationsModule/locations/83
Triage: Uncategorized
Uncategorized Operation 57
After
{
  "zip": "200347",
  "city": "Craiova",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 44.31667,
    "lon": 23.8
  }
}
add /protocolSection/contactsLocationsModule/locations/84
Triage: Uncategorized
Uncategorized Operation 58
After
{
  "zip": "700106",
  "city": "Iași",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 47.16667,
    "lon": 27.6
  }
}
replace /protocolSection/contactsLocationsModule/locations/88/status
Triage: Uncategorized
Uncategorized Operation 59
Before
NOT_YET_RECRUITING
After
RECRUITING
add /protocolSection/contactsLocationsModule/locations/90
Triage: Uncategorized
Uncategorized Operation 60
After
{
  "zip": "08035",
  "city": "Barcelona",
  "state": "Barcelona",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 41.38879,
    "lon": 2.15899
  }
}
add /protocolSection/contactsLocationsModule/locations/91
Triage: Uncategorized
Uncategorized Operation 61
After
{
  "zip": "23007",
  "city": "Jaén",
  "state": "Jaen",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 37.76922,
    "lon": -3.79028
  }
}
add /protocolSection/contactsLocationsModule/locations/92
Triage: Uncategorized
Uncategorized Operation 62
After
{
  "zip": "15706",
  "city": "Santiago de Compostela",
  "state": "La Coruña",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 42.88052,
    "lon": -8.54569
  }
}
add /protocolSection/contactsLocationsModule/locations/93
Triage: Uncategorized
Uncategorized Operation 63
After
{
  "zip": "28007",
  "city": "Madrid",
  "state": "Madrid",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
add /protocolSection/contactsLocationsModule/locations/94
Triage: Uncategorized
Uncategorized Operation 64
After
{
  "zip": "28033",
  "city": "Madrid",
  "state": "Madrid",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
add /protocolSection/contactsLocationsModule/locations/95
Triage: Uncategorized
Uncategorized Operation 65
After
{
  "zip": "28222",
  "city": "Madrid",
  "state": "Madrid",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
add /protocolSection/contactsLocationsModule/locations/96
Triage: Uncategorized
Uncategorized Operation 66
After
{
  "zip": "38320",
  "city": "San Cristóbal de La Laguna",
  "state": "Tenerife",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 28.4853,
    "lon": -16.32014
  }
}
add /protocolSection/contactsLocationsModule/locations/97
Triage: Uncategorized
Uncategorized Operation 67
After
{
  "zip": "46980",
  "city": "Valencia",
  "state": "Valencia",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 39.47391,
    "lon": -0.37966
  }
}
add /protocolSection/contactsLocationsModule/locations/98
Triage: Uncategorized
Uncategorized Operation 68
After
{
  "zip": "48903",
  "city": "Barakaldo",
  "state": "Vizcaya",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 43.29639,
    "lon": -2.98813
  }
}
add /protocolSection/contactsLocationsModule/locations/99
Triage: Uncategorized
Uncategorized Operation 69
After
{
  "zip": "50009",
  "city": "Zaragoza",
  "state": "Zaragoza",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 41.65606,
    "lon": -0.87734
  }
}
add /protocolSection/contactsLocationsModule/locations/100
Triage: Uncategorized
Uncategorized Operation 70
After
{
  "zip": "58185",
  "city": "Linköping",
  "status": "NOT_YET_RECRUITING",
  "country": "Sweden",
  "geoPoint": {
    "lat": 58.41086,
    "lon": 15.62157
  }
}
add /protocolSection/contactsLocationsModule/locations/101
Triage: Uncategorized
Uncategorized Operation 71
After
{
  "zip": "17176",
  "city": "Stockholm",
  "status": "NOT_YET_RECRUITING",
  "country": "Sweden",
  "geoPoint": {
    "lat": 59.32938,
    "lon": 18.06871
  }
}
add /protocolSection/contactsLocationsModule/locations/102
Triage: Uncategorized
Uncategorized Operation 72
After
{
  "zip": "75185",
  "city": "Uppsala",
  "status": "NOT_YET_RECRUITING",
  "country": "Sweden",
  "geoPoint": {
    "lat": 59.85882,
    "lon": 17.63889
  }
}
add /protocolSection/contactsLocationsModule/locations/103
Triage: Uncategorized
Uncategorized Operation 73
After
{
  "zip": "01250",
  "city": "Adana",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 36.98615,
    "lon": 35.32531
  }
}
add /protocolSection/contactsLocationsModule/locations/104
Triage: Uncategorized
Uncategorized Operation 74
After
{
  "zip": "22770",
  "city": "Edirne",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 41.67719,
    "lon": 26.55597
  }
}
add /protocolSection/contactsLocationsModule/locations/105
Triage: Uncategorized
Uncategorized Operation 75
After
{
  "zip": "34300",
  "city": "Istanbul",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 41.01384,
    "lon": 28.94966
  }
}
add /protocolSection/contactsLocationsModule/locations/106
Triage: Uncategorized
Uncategorized Operation 76
After
{
  "zip": "34742",
  "city": "Istanbul",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 41.01384,
    "lon": 28.94966
  }
}
add /protocolSection/contactsLocationsModule/locations/107
Triage: Uncategorized
Uncategorized Operation 77
After
{
  "zip": "06100",
  "city": "Sıhhiye, Ankara",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 39.91987,
    "lon": 32.85427
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2015-05-05
After
2015-05-11
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2015-05-06
After
2015-05-12
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 4
Before
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy.
The anticipated duration of the study is approximately 3.5 years.
After
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy.
There will be a 2:1 randomization to the taselisib arm versus the placebo arm.
Enrollment will be enriched for patients with PIK3CA mutant tumors via central testing.
The anticipated duration of the study is approximately 3.5 years.
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2015-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-05-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-05-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy.\nThere will be a 2:1 randomization to the taselisib arm versus the placebo arm.\nEnrollment will be enriched for patients with PIK3CA mutant tumors via central testing.\nThe anticipated duration of the study is approximately 3.5 years."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Overall objective response rate (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/status",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/city",
    "value": "Westminster"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/zip",
    "value": "21157"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lat",
    "value": 39.57538
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lon",
    "value": -76.99581
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/7",
    "value": {
      "zip": "63011",
      "city": "Ballwin",
      "state": "Missouri",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "geoPoint": {
        "lat": 38.59505,
        "lon": -90.54623
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/8",
    "value": {
      "zip": "63109",
      "city": "St Louis",
      "state": "Missouri",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "geoPoint": {
        "lat": 38.62727,
        "lon": -90.19789
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/10",
    "value": {
      "zip": "07920",
      "city": "Basking Ridge",
      "state": "New Jersey",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "geoPoint": {
        "lat": 40.70621,
        "lon": -74.54932
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/11",
    "value": {
      "zip": "11725",
      "city": "Commack",
      "state": "New York",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "geoPoint": {
        "lat": 40.84288,
        "lon": -73.29289
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/12",
    "value": {
      "zip": "10604",
      "city": "East White Plains",
      "state": "New York",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "geoPoint": {
        "lat": 41.03899,
        "lon": -73.74763
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/14",
    "value": {
      "zip": "11570",
      "city": "Rockville Centre",
      "state": "New York",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "geoPoint": {
        "lat": 40.65871,
        "lon": -73.64124
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/15",
    "value": {
      "zip": "10591",
      "city": "Sleepy Hollow",
      "state": "New York",
      "status": "NOT_YET_RECRUITING",
      "country": "United States",
      "geoPoint": {
        "lat": 41.08565,
        "lon": -73.85847
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/20"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/21",
    "value": {
      "zip": "3021",
      "city": "St Albans",
      "state": "Victoria",
      "status": "RECRUITING",
      "country": "Australia",
      "geoPoint": {
        "lat": -37.74496,
        "lon": 144.80049
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/27",
    "value": {
      "zip": "4004",
      "city": "Plovdiv",
      "status": "NOT_YET_RECRUITING",
      "country": "Bulgaria",
      "geoPoint": {
        "lat": 42.15387,
        "lon": 24.75001
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/28",
    "value": {
      "zip": "1330",
      "city": "Sofia",
      "status": "NOT_YET_RECRUITING",
      "country": "Bulgaria",
      "geoPoint": {
        "lat": 42.69751,
        "lon": 23.32415
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/29",
    "value": {
      "zip": "1756",
      "city": "Sofia",
      "status": "NOT_YET_RECRUITING",
      "country": "Bulgaria",
      "geoPoint": {
        "lat": 42.69751,
        "lon": 23.32415
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/30",
    "value": {
      "zip": "9010",
      "city": "Varna",
      "status": "NOT_YET_RECRUITING",
      "country": "Bulgaria",
      "geoPoint": {
        "lat": 43.21912,
        "lon": 27.91024
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/33",
    "value": {
      "zip": "N2G 1G3",
      "city": "Kitchener",
      "state": "Ontario",
      "status": "RECRUITING",
      "country": "Canada",
      "geoPoint": {
        "lat": 43.42537,
        "lon": -80.5112
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/36/zip",
    "value": "H2X 0A9"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/37",
    "value": {
      "zip": "H3T 1E2",
      "city": "Montreal",
      "state": "Quebec",
      "status": "RECRUITING",
      "country": "Canada",
      "geoPoint": {
        "lat": 45.50884,
        "lon": -73.58781
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/38",
    "value": {
      "zip": "QC G1S 4L8",
      "city": "Québec",
      "state": "Quebec",
      "status": "NOT_YET_RECRUITING",
      "country": "Canada",
      "geoPoint": {
        "lat": 46.81228,
        "lon": -71.21454
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/39",
    "value": {
      "zip": "500 05",
      "city": "Hradec Králové",
      "status": "NOT_YET_RECRUITING",
      "country": "Czechia",
      "geoPoint": {
        "lat": 50.20923,
        "lon": 15.83277
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/40",
    "value": {
      "zip": "775 20",
      "city": "Olomouc",
      "status": "NOT_YET_RECRUITING",
      "country": "Czechia",
      "geoPoint": {
        "lat": 49.59552,
        "lon": 17.25175
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/41",
    "value": {
      "zip": "532 03",
      "city": "Pardubice",
      "status": "NOT_YET_RECRUITING",
      "country": "Czechia",
      "geoPoint": {
        "lat": 50.04075,
        "lon": 15.77659
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/42",
    "value": {
      "zip": "128 08",
      "city": "Prague",
      "status": "NOT_YET_RECRUITING",
      "country": "Czechia",
      "geoPoint": {
        "lat": 50.08804,
        "lon": 14.42076
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/47",
    "value": {
      "zip": "87042",
      "city": "Limoges",
      "status": "NOT_YET_RECRUITING",
      "country": "France",
      "geoPoint": {
        "lat": 45.83362,
        "lon": 1.24759
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/54",
    "value": {
      "zip": "10367",
      "city": "Berlin",
      "status": "NOT_YET_RECRUITING",
      "country": "Germany",
      "geoPoint": {
        "lat": 52.52437,
        "lon": 13.41053
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/55",
    "value": {
      "zip": "10707",
      "city": "Berlin",
      "status": "NOT_YET_RECRUITING",
      "country": "Germany",
      "geoPoint": {
        "lat": 52.52437,
        "lon": 13.41053
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/56",
    "value": {
      "zip": "45122",
      "city": "Essen",
      "status": "NOT_YET_RECRUITING",
      "country": "Germany",
      "geoPoint": {
        "lat": 51.45657,
        "lon": 7.01228
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/57",
    "value": {
      "zip": "36043",
      "city": "Fulda",
      "status": "NOT_YET_RECRUITING",
      "country": "Germany",
      "geoPoint": {
        "lat": 50.55162,
        "lon": 9.67518
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/58",
    "value": {
      "zip": "20357",
      "city": "Hamburg",
      "status": "NOT_YET_RECRUITING",
      "country": "Germany",
      "geoPoint": {
        "lat": 53.55073,
        "lon": 9.99302
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/59",
    "value": {
      "zip": "30559",
      "city": "Hanover",
      "status": "NOT_YET_RECRUITING",
      "country": "Germany",
      "geoPoint": {
        "lat": 52.37052,
        "lon": 9.73322
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/60",
    "value": {
      "zip": "54290",
      "city": "Trier",
      "status": "NOT_YET_RECRUITING",
      "country": "Germany",
      "geoPoint": {
        "lat": 49.75565,
        "lon": 6.63935
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/61",
    "value": {
      "zip": "80131",
      "city": "Naples",
      "state": "Campania",
      "status": "RECRUITING",
      "country": "Italy",
      "geoPoint": {
        "lat": 40.85216,
        "lon": 14.26811
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/62",
    "value": {
      "zip": "20141",
      "city": "Milan",
      "state": "Lombardy",
      "status": "RECRUITING",
      "country": "Italy",
      "geoPoint": {
        "lat": 45.46427,
        "lon": 9.18951
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/66",
    "value": {
      "zip": "34",
      "city": "Lima",
      "status": "NOT_YET_RECRUITING",
      "country": "Peru",
      "geoPoint": {
        "lat": -12.04318,
        "lon": -77.02824
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/67",
    "value": {
      "zip": "15-027",
      "city": "Bialystok",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 53.13333,
        "lon": 23.16433
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/68",
    "value": {
      "zip": "85-796",
      "city": "Bydgoszcz",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 53.1235,
        "lon": 18.00762
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/69",
    "value": {
      "zip": "80-952",
      "city": "Gdansk",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 54.35227,
        "lon": 18.64912
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/70",
    "value": {
      "zip": "62-500",
      "city": "Konin",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 52.22338,
        "lon": 18.25121
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/71",
    "value": {
      "zip": "31-531",
      "city": "Krakow",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 50.06143,
        "lon": 19.93658
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/72",
    "value": {
      "zip": "93-513",
      "city": "Lodz",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 51.77058,
        "lon": 19.47395
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/73",
    "value": {
      "zip": "20-090",
      "city": "Lublin",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 51.25058,
        "lon": 22.57009
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/74",
    "value": {
      "zip": "71-730",
      "city": "Szczecin",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 53.42894,
        "lon": 14.55302
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/75",
    "value": {
      "zip": "87-100",
      "city": "Torun",
      "status": "NOT_YET_RECRUITING",
      "country": "Poland",
      "geoPoint": {
        "lat": 53.01375,
        "lon": 18.59814
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/80",
    "value": {
      "zip": "022328",
      "city": "Bucharest",
      "status": "NOT_YET_RECRUITING",
      "country": "Romania",
      "geoPoint": {
        "lat": 44.43225,
        "lon": 26.10626
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/81",
    "value": {
      "zip": "400015",
      "city": "Cluj-Napoca",
      "status": "NOT_YET_RECRUITING",
      "country": "Romania",
      "geoPoint": {
        "lat": 46.76667,
        "lon": 23.6
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/82",
    "value": {
      "zip": "400349",
      "city": "Cluj-Napoca",
      "status": "NOT_YET_RECRUITING",
      "country": "Romania",
      "geoPoint": {
        "lat": 46.76667,
        "lon": 23.6
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/83",
    "value": {
      "zip": "200347",
      "city": "Craiova",
      "status": "NOT_YET_RECRUITING",
      "country": "Romania",
      "geoPoint": {
        "lat": 44.31667,
        "lon": 23.8
      }
    }
  },
  {
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    "path": "/protocolSection/contactsLocationsModule/locations/84",
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      "country": "Romania",
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    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/88/status",
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  },
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    "op": "add",
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      "country": "Spain",
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    "op": "add",
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    "op": "add",
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      "country": "Spain",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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    "op": "add",
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  },
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    "op": "add",
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    "op": "add",
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]