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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 8 to 9 · Hoffmann-La Roche

Patch inspector

Version 8 to 9

52 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
secondary_outcome_any_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:11:43+00
Raw hash
e41144890051a854deb5693384020570918f61d527424bf4d1cbae73fa130006
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 4
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Overall objective response rate (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1
After
Overall objective response (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 48 ops
replace /protocolSection/contactsLocationsModule/locations/4/status
Triage: Uncategorized
Uncategorized Operation 5
Before
RECRUITING
After
NOT_YET_RECRUITING
replace /protocolSection/contactsLocationsModule/locations/5/city
Triage: Uncategorized
Uncategorized Operation 6
Before
Westminster
After
Rockville
replace /protocolSection/contactsLocationsModule/locations/5/zip
Triage: Uncategorized
Uncategorized Operation 7
Before
21157
After
20850
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 8
Before
39.57538
After
39.084
replace /protocolSection/contactsLocationsModule/locations/5/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 9
Before
-76.99581
After
-77.15276
remove /protocolSection/contactsLocationsModule/locations/10
Triage: Uncategorized
Uncategorized Operation 10
Before
{
  "zip": "37232",
  "city": "Nashville",
  "state": "Tennessee",
  "status": "NOT_YET_RECRUITING",
  "country": "United States",
  "geoPoint": {
    "lat": 36.16589,
    "lon": -86.78444
  }
}
add /protocolSection/contactsLocationsModule/locations/13
Triage: Uncategorized
Uncategorized Operation 11
After
{
  "zip": "3011",
  "city": "Footscray",
  "state": "Victoria",
  "status": "NOT_YET_RECRUITING",
  "country": "Australia",
  "geoPoint": {
    "lat": -37.8,
    "lon": 144.9
  }
}
remove /protocolSection/contactsLocationsModule/locations/15
Triage: Uncategorized
Uncategorized Operation 12
Before
{
  "city": "St Albans",
  "state": "Victoria",
  "status": "NOT_YET_RECRUITING",
  "country": "Australia",
  "geoPoint": {
    "lat": -37.74496,
    "lon": 144.80049
  }
}
remove /protocolSection/contactsLocationsModule/locations/20
Triage: Uncategorized
Uncategorized Operation 13
Before
{
  "zip": "4004",
  "city": "Plovdiv",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 42.15387,
    "lon": 24.75001
  }
}
remove /protocolSection/contactsLocationsModule/locations/20
Triage: Uncategorized
Uncategorized Operation 14
Before
{
  "zip": "1330",
  "city": "Sofia",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 42.69751,
    "lon": 23.32415
  }
}
remove /protocolSection/contactsLocationsModule/locations/20
Triage: Uncategorized
Uncategorized Operation 15
Before
{
  "zip": "1756",
  "city": "Sofia",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 42.69751,
    "lon": 23.32415
  }
}
remove /protocolSection/contactsLocationsModule/locations/20
Triage: Uncategorized
Uncategorized Operation 16
Before
{
  "zip": "9010",
  "city": "Varna",
  "status": "NOT_YET_RECRUITING",
  "country": "Bulgaria",
  "geoPoint": {
    "lat": 43.21912,
    "lon": 27.91024
  }
}
remove /protocolSection/contactsLocationsModule/locations/22
Triage: Uncategorized
Uncategorized Operation 17
Before
{
  "zip": "N2G 1G3",
  "city": "Kitchener",
  "state": "Ontario",
  "status": "RECRUITING",
  "country": "Canada",
  "geoPoint": {
    "lat": 43.42537,
    "lon": -80.5112
  }
}
remove /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 18
Before
{
  "zip": "H3T 1E2",
  "city": "Montreal",
  "state": "Quebec",
  "status": "NOT_YET_RECRUITING",
  "country": "Canada",
  "geoPoint": {
    "lat": 45.50884,
    "lon": -73.58781
  }
}
remove /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 19
Before
{
  "zip": "QC G1S 4L8",
  "city": "Québec",
  "state": "Quebec",
  "status": "NOT_YET_RECRUITING",
  "country": "Canada",
  "geoPoint": {
    "lat": 46.81228,
    "lon": -71.21454
  }
}
remove /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 20
Before
{
  "zip": "500 05",
  "city": "Hradec Králové",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 50.20923,
    "lon": 15.83277
  }
}
remove /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 21
Before
{
  "zip": "775 20",
  "city": "Olomouc",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 49.59552,
    "lon": 17.25175
  }
}
remove /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 22
Before
{
  "zip": "532 03",
  "city": "Pardubice",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 50.04075,
    "lon": 15.77659
  }
}
remove /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 23
Before
{
  "zip": "128 08",
  "city": "Prague",
  "status": "NOT_YET_RECRUITING",
  "country": "Czechia",
  "geoPoint": {
    "lat": 50.08804,
    "lon": 14.42076
  }
}
remove /protocolSection/contactsLocationsModule/locations/29
Triage: Uncategorized
Uncategorized Operation 24
Before
{
  "zip": "87042",
  "city": "Limoges",
  "status": "NOT_YET_RECRUITING",
  "country": "France",
  "geoPoint": {
    "lat": 45.83362,
    "lon": 1.24759
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 25
Before
{
  "zip": "15-027",
  "city": "Bialystok",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.13333,
    "lon": 23.16433
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 26
Before
{
  "zip": "85-796",
  "city": "Bydgoszcz",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.1235,
    "lon": 18.00762
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 27
Before
{
  "zip": "80-952",
  "city": "Gdansk",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 54.35227,
    "lon": 18.64912
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 28
Before
{
  "zip": "62-500",
  "city": "Konin",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 52.22338,
    "lon": 18.25121
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 29
Before
{
  "zip": "31-531",
  "city": "Krakow",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 50.06143,
    "lon": 19.93658
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 30
Before
{
  "zip": "93-513",
  "city": "Lodz",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 51.77058,
    "lon": 19.47395
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 31
Before
{
  "zip": "20-090",
  "city": "Lublin",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 51.25058,
    "lon": 22.57009
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 32
Before
{
  "zip": "71-730",
  "city": "Szczecin",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.42894,
    "lon": 14.55302
  }
}
remove /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 33
Before
{
  "zip": "87-100",
  "city": "Torun",
  "status": "NOT_YET_RECRUITING",
  "country": "Poland",
  "geoPoint": {
    "lat": 53.01375,
    "lon": 18.59814
  }
}
remove /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 34
Before
{
  "zip": "022328",
  "city": "Bucharest",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 44.43225,
    "lon": 26.10626
  }
}
remove /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 35
Before
{
  "zip": "400006",
  "city": "Cluj-Napoca",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 46.76667,
    "lon": 23.6
  }
}
remove /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 36
Before
{
  "zip": "400015",
  "city": "Cluj-Napoca",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 46.76667,
    "lon": 23.6
  }
}
remove /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 37
Before
{
  "zip": "200385",
  "city": "Craiova",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 44.31667,
    "lon": 23.8
  }
}
remove /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 38
Before
{
  "zip": "700106",
  "city": "Iași",
  "status": "NOT_YET_RECRUITING",
  "country": "Romania",
  "geoPoint": {
    "lat": 47.16667,
    "lon": 27.6
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 39
Before
{
  "zip": "08035",
  "city": "Barcelona",
  "state": "Barcelona",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 41.38879,
    "lon": 2.15899
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 40
Before
{
  "zip": "23007",
  "city": "Jaén",
  "state": "Jaen",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 37.76922,
    "lon": -3.79028
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 41
Before
{
  "zip": "15706",
  "city": "Santiago de Compostela",
  "state": "La Coruña",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 42.88052,
    "lon": -8.54569
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 42
Before
{
  "zip": "28007",
  "city": "Madrid",
  "state": "Madrid",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 43
Before
{
  "zip": "28033",
  "city": "Madrid",
  "state": "Madrid",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 44
Before
{
  "zip": "38320",
  "city": "San Cristóbal de La Laguna",
  "state": "Tenerife",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 28.4853,
    "lon": -16.32014
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 45
Before
{
  "zip": "46980",
  "city": "Valencia",
  "state": "Valencia",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 39.47391,
    "lon": -0.37966
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 46
Before
{
  "zip": "48903",
  "city": "Barakaldo",
  "state": "Vizcaya",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 43.29639,
    "lon": -2.98813
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 47
Before
{
  "zip": "50009",
  "city": "Zaragoza",
  "state": "Zaragoza",
  "status": "RECRUITING",
  "country": "Spain",
  "geoPoint": {
    "lat": 41.65606,
    "lon": -0.87734
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 48
Before
{
  "zip": "01250",
  "city": "Adana",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 36.98615,
    "lon": 35.32531
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 49
Before
{
  "zip": "22770",
  "city": "Edirne",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 41.67719,
    "lon": 26.55597
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 50
Before
{
  "zip": "34300",
  "city": "Istanbul",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 41.01384,
    "lon": 28.94966
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 51
Before
{
  "zip": "34742",
  "city": "Istanbul",
  "status": "NOT_YET_RECRUITING",
  "country": "Turkey (Türkiye)",
  "geoPoint": {
    "lat": 41.01384,
    "lon": 28.94966
  }
}
remove /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
Uncategorized Operation 52
Before
{
  "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 1
Before
2015-03-23
After
2015-04-02
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 2
Before
2015-03-24
After
2015-04-06
replace /protocolSection/descriptionModule/briefSummary
Triage: Uncategorized
Uncategorized Operation 3
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.
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.
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.
The anticipated duration of the study is approximately 3.5 years.
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2015-04-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2015-04-06"
  },
  {
    "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.\nThe anticipated duration of the study is approximately 3.5 years."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
    "value": "Overall objective response (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/4/status",
    "value": "NOT_YET_RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/city",
    "value": "Rockville"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/zip",
    "value": "20850"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lat",
    "value": 39.084
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/5/geoPoint/lon",
    "value": -77.15276
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/10"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/13",
    "value": {
      "zip": "3011",
      "city": "Footscray",
      "state": "Victoria",
      "status": "NOT_YET_RECRUITING",
      "country": "Australia",
      "geoPoint": {
        "lat": -37.8,
        "lon": 144.9
      }
    }
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/15"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/20"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/20"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/20"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/20"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/22"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/25"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/25"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/25"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/25"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/25"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/25"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/29"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/38"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/38"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/38"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/38"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/38"
  },
  {
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]