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NCT00099437

Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.

Version 1 to 2 · AstraZeneca

Patch inspector

Version 1 to 2

88 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
eligibility_criteria_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:57+00
Raw hash
df52e31f2c6102a604dbfbeafff059958d62d9a0d6a203ff96fd3d42a9049e9a
Payload
Source URL
Eligibility Criteria and population definition changes. Triage: High 3 ops
replace /protocolSection/eligibilityModule/eligibilityCriteria
Triage: High
Eligibility Change Operation 6
Matched rules
  • eligibility_criteria_change Eligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ul><li>Provision of written informed consent</li><li>Postmenopausal women defined as those who have stopped their menstrual periods.</li><li>Histological&#x2F;cytological confirmation of breast cancer</li><li>Documented positive estrogen receptor status (ER +ve) of primary or metastatic tumor tissue, according to the local laboratory parameters.</li><li>Requiring hormonal treatment</li></ul><p>Exclusion Criteria:</p><ul><li>Presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread</li><li>More than one regimen of chemotherapy for advanced disease</li><li>More than one regimen of endocrine therapy for advanced disease.</li></ul>
After
<p>Inclusion Criteria:</p><ul><li>Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor</li><li>Requiring hormonal treatment</li><li>Postmenopausal women defined as a woman who has stopped having menstrual periods</li><li>Evidence of positive estrogen receptor hormone sensitivity</li><li>Written informed consent to participate in the trial</li></ul><p>Exclusion Criteria:</p><ul><li>Treatment with an investigational or non-approved drug within one month</li><li>An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures</li><li>A history of allergies to any active or inactive ingredients of Faslodex (i.e.
castor oil)</li><li>Treatment with more than one regimen of chemotherapy for advanced breast cancer</li><li>Treatment with more than one regimen of hormonal treatment for advanced breast cancer</li></ul>
replace /protocolSection/eligibilityModule/minimumAge
Triage: Uncategorized
Uncategorized Operation 7
Before
18 Years
After
0 Years
add /protocolSection/eligibilityModule/stdAges/0
Triage: Uncategorized
Uncategorized Operation 8
After
CHILD
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Uncategorized 80 ops
add /protocolSection/contactsLocationsModule/locations/0
Triage: Uncategorized
Uncategorized Operation 9
After
{
  "city": "Casa Grande",
  "state": "Arizona",
  "status": "RECRUITING",
  "country": "United States",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 32.8795,
    "lon": -111.75735
  }
}
replace /protocolSection/contactsLocationsModule/locations/9/city
Triage: Uncategorized
Uncategorized Operation 10
Before
Cary
After
Voorhees Township
replace /protocolSection/contactsLocationsModule/locations/9/state
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Uncategorized Operation 11
Before
North Carolina
After
New Jersey
replace /protocolSection/contactsLocationsModule/locations/9/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 12
Before
35.79154
After
40.4795
replace /protocolSection/contactsLocationsModule/locations/9/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 13
Before
-78.78112
After
-74.49062
replace /protocolSection/contactsLocationsModule/locations/12/city
Triage: Uncategorized
Uncategorized Operation 14
Before
Houston
After
Pasadena
replace /protocolSection/contactsLocationsModule/locations/12/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 15
Before
29.76328
After
29.69106
replace /protocolSection/contactsLocationsModule/locations/12/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 16
Before
-95.36327
After
-95.2091
replace /protocolSection/contactsLocationsModule/locations/14/city
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Uncategorized Operation 17
Before
Brookfield
After
West Bend
replace /protocolSection/contactsLocationsModule/locations/14/geoPoint/lat
Triage: Uncategorized
Uncategorized Operation 18
Before
43.06057
After
43.42528
replace /protocolSection/contactsLocationsModule/locations/14/geoPoint/lon
Triage: Uncategorized
Uncategorized Operation 19
Before
-88.10648
After
-88.18343
add /protocolSection/contactsLocationsModule/locations/15
Triage: Uncategorized
Uncategorized Operation 20
After
{
  "city": "Brasschaat",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 51.2912,
    "lon": 4.49182
  }
}
add /protocolSection/contactsLocationsModule/locations/16
Triage: Uncategorized
Uncategorized Operation 21
After
{
  "city": "Bruges",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 51.20892,
    "lon": 3.22424
  }
}
add /protocolSection/contactsLocationsModule/locations/17
Triage: Uncategorized
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After
{
  "city": "Brussels",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 50.85045,
    "lon": 4.34878
  }
}
add /protocolSection/contactsLocationsModule/locations/18
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After
{
  "city": "Edegem",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 51.15662,
    "lon": 4.44504
  }
}
add /protocolSection/contactsLocationsModule/locations/19
Triage: Uncategorized
Uncategorized Operation 24
After
{
  "city": "Ghent",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 51.05,
    "lon": 3.71667
  }
}
add /protocolSection/contactsLocationsModule/locations/20
Triage: Uncategorized
Uncategorized Operation 25
After
{
  "city": "Hasselt",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 50.93106,
    "lon": 5.33781
  }
}
add /protocolSection/contactsLocationsModule/locations/21
Triage: Uncategorized
Uncategorized Operation 26
After
{
  "city": "Liège",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 50.63373,
    "lon": 5.56749
  }
}
add /protocolSection/contactsLocationsModule/locations/22
Triage: Uncategorized
Uncategorized Operation 27
After
{
  "city": "Turnhout",
  "status": "RECRUITING",
  "country": "Belgium",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 51.32254,
    "lon": 4.94471
  }
}
add /protocolSection/contactsLocationsModule/locations/23
Triage: Uncategorized
Uncategorized Operation 28
After
{
  "city": "Barretos",
  "status": "NOT_YET_RECRUITING",
  "country": "Brazil",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -20.55722,
    "lon": -48.56778
  }
}
add /protocolSection/contactsLocationsModule/locations/24
Triage: Uncategorized
Uncategorized Operation 29
After
{
  "city": "Goiânia",
  "status": "NOT_YET_RECRUITING",
  "country": "Brazil",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -16.67861,
    "lon": -49.25389
  }
}
add /protocolSection/contactsLocationsModule/locations/25
Triage: Uncategorized
Uncategorized Operation 30
After
{
  "city": "Londrina",
  "status": "NOT_YET_RECRUITING",
  "country": "Brazil",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -23.31028,
    "lon": -51.16278
  }
}
add /protocolSection/contactsLocationsModule/locations/26
Triage: Uncategorized
Uncategorized Operation 31
After
{
  "city": "Porto Alegre",
  "status": "NOT_YET_RECRUITING",
  "country": "Brazil",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -30.03283,
    "lon": -51.23019
  }
}
add /protocolSection/contactsLocationsModule/locations/27
Triage: Uncategorized
Uncategorized Operation 32
After
{
  "city": "Recife",
  "status": "NOT_YET_RECRUITING",
  "country": "Brazil",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -8.05389,
    "lon": -34.88111
  }
}
add /protocolSection/contactsLocationsModule/locations/28
Triage: Uncategorized
Uncategorized Operation 33
After
{
  "city": "Salvador",
  "status": "NOT_YET_RECRUITING",
  "country": "Brazil",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -12.97563,
    "lon": -38.49096
  }
}
add /protocolSection/contactsLocationsModule/locations/29
Triage: Uncategorized
Uncategorized Operation 34
After
{
  "city": "São Paulo",
  "status": "NOT_YET_RECRUITING",
  "country": "Brazil",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -23.5475,
    "lon": -46.63611
  }
}
add /protocolSection/contactsLocationsModule/locations/30
Triage: Uncategorized
Uncategorized Operation 35
After
{
  "city": "Antofagasta",
  "status": "NOT_YET_RECRUITING",
  "country": "Chile",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -23.65094,
    "lon": -70.39752
  }
}
add /protocolSection/contactsLocationsModule/locations/31
Triage: Uncategorized
Uncategorized Operation 36
After
{
  "city": "Santiago",
  "status": "NOT_YET_RECRUITING",
  "country": "Chile",
  "facility": "Research Site",
  "geoPoint": {
    "lat": -33.45694,
    "lon": -70.64827
  }
}
add /protocolSection/contactsLocationsModule/locations/32
Triage: Uncategorized
Uncategorized Operation 37
After
{
  "city": "Antioquia",
  "status": "NOT_YET_RECRUITING",
  "country": "Colombia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 4.6,
    "lon": -74.4
  }
}
add /protocolSection/contactsLocationsModule/locations/33
Triage: Uncategorized
Uncategorized Operation 38
After
{
  "city": "Bogotá",
  "status": "NOT_YET_RECRUITING",
  "country": "Colombia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 4.60971,
    "lon": -74.08175
  }
}
add /protocolSection/contactsLocationsModule/locations/34
Triage: Uncategorized
Uncategorized Operation 39
After
{
  "city": "Cali",
  "status": "NOT_YET_RECRUITING",
  "country": "Colombia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 3.43054,
    "lon": -76.5199
  }
}
add /protocolSection/contactsLocationsModule/locations/35
Triage: Uncategorized
Uncategorized Operation 40
After
{
  "city": "Brno",
  "status": "RECRUITING",
  "country": "Czechia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 49.19522,
    "lon": 16.60796
  }
}
add /protocolSection/contactsLocationsModule/locations/36
Triage: Uncategorized
Uncategorized Operation 41
After
{
  "city": "Pardubice",
  "status": "RECRUITING",
  "country": "Czechia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 50.04075,
    "lon": 15.77659
  }
}
add /protocolSection/contactsLocationsModule/locations/37
Triage: Uncategorized
Uncategorized Operation 42
After
{
  "city": "Prague",
  "status": "RECRUITING",
  "country": "Czechia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 50.08804,
    "lon": 14.42076
  }
}
add /protocolSection/contactsLocationsModule/locations/38
Triage: Uncategorized
Uncategorized Operation 43
After
{
  "city": "Praha-2",
  "status": "RECRUITING",
  "country": "Czechia",
  "facility": "Research Site"
}
add /protocolSection/contactsLocationsModule/locations/39
Triage: Uncategorized
Uncategorized Operation 44
After
{
  "city": "Tábor",
  "status": "RECRUITING",
  "country": "Czechia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 49.41441,
    "lon": 14.6578
  }
}
add /protocolSection/contactsLocationsModule/locations/40
Triage: Uncategorized
Uncategorized Operation 45
After
{
  "city": "Budapest",
  "status": "NOT_YET_RECRUITING",
  "country": "Hungary",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 47.49835,
    "lon": 19.04045
  }
}
add /protocolSection/contactsLocationsModule/locations/41
Triage: Uncategorized
Uncategorized Operation 46
After
{
  "city": "Kecskemét",
  "status": "NOT_YET_RECRUITING",
  "country": "Hungary",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 46.90618,
    "lon": 19.69128
  }
}
add /protocolSection/contactsLocationsModule/locations/42
Triage: Uncategorized
Uncategorized Operation 47
After
{
  "city": "Nyíregyháza",
  "status": "RECRUITING",
  "country": "Hungary",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 47.95539,
    "lon": 21.71671
  }
}
add /protocolSection/contactsLocationsModule/locations/43
Triage: Uncategorized
Uncategorized Operation 48
After
{
  "city": "Székesfehérvár",
  "status": "RECRUITING",
  "country": "Hungary",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 47.18995,
    "lon": 18.41034
  }
}
add /protocolSection/contactsLocationsModule/locations/44
Triage: Uncategorized
Uncategorized Operation 49
After
{
  "city": "Bhopal",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 23.25469,
    "lon": 77.40289
  }
}
add /protocolSection/contactsLocationsModule/locations/45
Triage: Uncategorized
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After
{
  "city": "Hyderabad",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 17.38405,
    "lon": 78.45636
  }
}
add /protocolSection/contactsLocationsModule/locations/46
Triage: Uncategorized
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After
{
  "city": "Jaipur",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 26.91962,
    "lon": 75.78781
  }
}
add /protocolSection/contactsLocationsModule/locations/47
Triage: Uncategorized
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After
{
  "city": "Mumbai",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 19.07283,
    "lon": 72.88261
  }
}
add /protocolSection/contactsLocationsModule/locations/48
Triage: Uncategorized
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After
{
  "city": "New Delhi",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 28.62137,
    "lon": 77.2148
  }
}
add /protocolSection/contactsLocationsModule/locations/49
Triage: Uncategorized
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{
  "city": "Pune",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 18.51957,
    "lon": 73.85535
  }
}
add /protocolSection/contactsLocationsModule/locations/50
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{
  "city": "Trivandrum",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 8.4855,
    "lon": 76.94924
  }
}
add /protocolSection/contactsLocationsModule/locations/51
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{
  "city": "Vellrore",
  "status": "NOT_YET_RECRUITING",
  "country": "India",
  "facility": "Research Site"
}
add /protocolSection/contactsLocationsModule/locations/52
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{
  "city": "Aviano (PN)",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 46.07056,
    "lon": 12.59472
  }
}
add /protocolSection/contactsLocationsModule/locations/53
Triage: Uncategorized
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{
  "city": "Bergamo",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 45.69601,
    "lon": 9.66721
  }
}
add /protocolSection/contactsLocationsModule/locations/54
Triage: Uncategorized
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{
  "city": "Capri city",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 40.55073,
    "lon": 14.24263
  }
}
add /protocolSection/contactsLocationsModule/locations/55
Triage: Uncategorized
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After
{
  "city": "Genova",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 45.21604,
    "lon": 11.87211
  }
}
add /protocolSection/contactsLocationsModule/locations/56
Triage: Uncategorized
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{
  "city": "Milan",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 42.78235,
    "lon": 12.59836
  }
}
add /protocolSection/contactsLocationsModule/locations/57
Triage: Uncategorized
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After
{
  "city": "Prato",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 43.8805,
    "lon": 11.09699
  }
}
add /protocolSection/contactsLocationsModule/locations/58
Triage: Uncategorized
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After
{
  "city": "Reggio Emilia",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 44.69825,
    "lon": 10.63125
  }
}
add /protocolSection/contactsLocationsModule/locations/59
Triage: Uncategorized
Uncategorized Operation 64
After
{
  "city": "Trieste",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 45.64953,
    "lon": 13.77678
  }
}
add /protocolSection/contactsLocationsModule/locations/60
Triage: Uncategorized
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After
{
  "city": "Varese",
  "status": "NOT_YET_RECRUITING",
  "country": "Italy",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 45.82058,
    "lon": 8.82511
  }
}
add /protocolSection/contactsLocationsModule/locations/61
Triage: Uncategorized
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After
{
  "city": "Guadalajara",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 20.67738,
    "lon": -103.34749
  }
}
add /protocolSection/contactsLocationsModule/locations/62
Triage: Uncategorized
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{
  "city": "México",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 31.00435,
    "lon": -108.15213
  }
}
add /protocolSection/contactsLocationsModule/locations/63
Triage: Uncategorized
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After
{
  "city": "Monterrey",
  "status": "NOT_YET_RECRUITING",
  "country": "Mexico",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 25.68435,
    "lon": -100.31721
  }
}
add /protocolSection/contactsLocationsModule/locations/64
Triage: Uncategorized
Uncategorized Operation 69
After
{
  "city": "Ivanovo",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 56.99988,
    "lon": 40.97257
  }
}
add /protocolSection/contactsLocationsModule/locations/65
Triage: Uncategorized
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After
{
  "city": "Kazan'",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 55.78874,
    "lon": 49.12214
  }
}
add /protocolSection/contactsLocationsModule/locations/66
Triage: Uncategorized
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After
{
  "city": "Krasnodar",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 45.04534,
    "lon": 38.98178
  }
}
add /protocolSection/contactsLocationsModule/locations/67
Triage: Uncategorized
Uncategorized Operation 72
After
{
  "city": "Lipetsk",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 52.5876,
    "lon": 39.55151
  }
}
add /protocolSection/contactsLocationsModule/locations/68
Triage: Uncategorized
Uncategorized Operation 73
After
{
  "city": "Moscow",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 55.75204,
    "lon": 37.61781
  }
}
add /protocolSection/contactsLocationsModule/locations/69
Triage: Uncategorized
Uncategorized Operation 74
After
{
  "city": "Nizhny Novgorod",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 56.32867,
    "lon": 44.00205
  }
}
add /protocolSection/contactsLocationsModule/locations/70
Triage: Uncategorized
Uncategorized Operation 75
After
{
  "city": "Obninsk",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 55.10993,
    "lon": 36.61238
  }
}
add /protocolSection/contactsLocationsModule/locations/71
Triage: Uncategorized
Uncategorized Operation 76
After
{
  "city": "Ryazan",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 54.62696,
    "lon": 39.70415
  }
}
add /protocolSection/contactsLocationsModule/locations/72
Triage: Uncategorized
Uncategorized Operation 77
After
{
  "city": "Saint Petersburg",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 59.93863,
    "lon": 30.31413
  }
}
add /protocolSection/contactsLocationsModule/locations/73
Triage: Uncategorized
Uncategorized Operation 78
After
{
  "city": "Yaroslavl",
  "status": "RECRUITING",
  "country": "Russia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 57.62987,
    "lon": 39.87368
  }
}
add /protocolSection/contactsLocationsModule/locations/74
Triage: Uncategorized
Uncategorized Operation 79
After
{
  "city": "Banská Bystrica",
  "status": "NOT_YET_RECRUITING",
  "country": "Slovakia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 48.73947,
    "lon": 19.14932
  }
}
remove /protocolSection/contactsLocationsModule/locations/77
Triage: Uncategorized
Uncategorized Operation 80
Before
{
  "city": "Nitra",
  "status": "RECRUITING",
  "country": "Slovakia",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 48.30763,
    "lon": 18.08453
  }
}
add /protocolSection/contactsLocationsModule/locations/80
Triage: Uncategorized
Uncategorized Operation 81
After
{
  "city": "A Coruña",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 43.37135,
    "lon": -8.396
  }
}
add /protocolSection/contactsLocationsModule/locations/81
Triage: Uncategorized
Uncategorized Operation 82
After
{
  "city": "Madrid",
  "status": "RECRUITING",
  "country": "Spain",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 40.4165,
    "lon": -3.70256
  }
}
add /protocolSection/contactsLocationsModule/locations/82
Triage: Uncategorized
Uncategorized Operation 83
After
{
  "city": "Málaga",
  "status": "RECRUITING",
  "country": "Spain",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 36.72016,
    "lon": -4.42034
  }
}
add /protocolSection/contactsLocationsModule/locations/83
Triage: Uncategorized
Uncategorized Operation 84
After
{
  "city": "Oviedo",
  "status": "RECRUITING",
  "country": "Spain",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 43.36029,
    "lon": -5.84476
  }
}
add /protocolSection/contactsLocationsModule/locations/84
Triage: Uncategorized
Uncategorized Operation 85
After
{
  "city": "Salamanca",
  "status": "RECRUITING",
  "country": "Spain",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 40.42972,
    "lon": -3.67975
  }
}
add /protocolSection/contactsLocationsModule/locations/85
Triage: Uncategorized
Uncategorized Operation 86
After
{
  "city": "Seville",
  "status": "RECRUITING",
  "country": "Spain",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 37.38283,
    "lon": -5.97317
  }
}
add /protocolSection/contactsLocationsModule/locations/86
Triage: Uncategorized
Uncategorized Operation 87
After
{
  "city": "Zaragoza",
  "status": "NOT_YET_RECRUITING",
  "country": "Spain",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 41.65606,
    "lon": -0.87734
  }
}
add /protocolSection/contactsLocationsModule/locations/87
Triage: Uncategorized
Uncategorized Operation 88
After
{
  "city": "Caracas",
  "status": "NOT_YET_RECRUITING",
  "country": "Venezuela",
  "facility": "Research Site",
  "geoPoint": {
    "lat": 10.48801,
    "lon": -66.87919
  }
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2005-08
After
2005-09
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2005-08-22
After
2005-09-26
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2005-08-23
After
2005-09-29
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 2 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
A Comparison of the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500mg with Fulvestrant (FASLODEX™) 250mg in Postmenopausal Women with Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
After
A Comparison of the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500mg With Fulvestrant (FASLODEX™) 250mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
replace /protocolSection/identificationModule/officialTitle
Triage: Uncategorized
Uncategorized Operation 2
Before
A Comparison of the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 Mg with Fulvestrant (FASLODEX™) 250 Mg in Postmenopausal Women with Estrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
After
A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 Mg With Fulvestrant (FASLODEX™) 250 Mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "A Comparison of the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500mg With Fulvestrant (FASLODEX™) 250mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy."
  },
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/officialTitle",
    "value": "A Randomised, Double-Blind, Parallel-Group, Multicentre, Phase III Study Comparing the Efficacy and Tolerability of Fulvestrant (FASLODEX™) 500 Mg With Fulvestrant (FASLODEX™) 250 Mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2005-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2005-09-26"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2005-09-29"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor</li><li>Requiring hormonal treatment</li><li>Postmenopausal women defined as a woman who has stopped having menstrual periods</li><li>Evidence of positive estrogen receptor hormone sensitivity</li><li>Written informed consent to participate in the trial</li></ul><p>Exclusion Criteria:</p><ul><li>Treatment with an investigational or non-approved drug within one month</li><li>An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures</li><li>A history of allergies to any active or inactive ingredients of Faslodex (i.e.\ncastor oil)</li><li>Treatment with more than one regimen of chemotherapy for advanced breast cancer</li><li>Treatment with more than one regimen of hormonal treatment for advanced breast cancer</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/minimumAge",
    "value": "0 Years"
  },
  {
    "op": "add",
    "path": "/protocolSection/eligibilityModule/stdAges/0",
    "value": "CHILD"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0",
    "value": {
      "city": "Casa Grande",
      "state": "Arizona",
      "status": "RECRUITING",
      "country": "United States",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 32.8795,
        "lon": -111.75735
      }
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/city",
    "value": "Voorhees Township"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/state",
    "value": "New Jersey"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/geoPoint/lat",
    "value": 40.4795
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/9/geoPoint/lon",
    "value": -74.49062
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/12/city",
    "value": "Pasadena"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/12/geoPoint/lat",
    "value": 29.69106
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/12/geoPoint/lon",
    "value": -95.2091
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/14/city",
    "value": "West Bend"
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/14/geoPoint/lat",
    "value": 43.42528
  },
  {
    "op": "replace",
    "path": "/protocolSection/contactsLocationsModule/locations/14/geoPoint/lon",
    "value": -88.18343
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/15",
    "value": {
      "city": "Brasschaat",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 51.2912,
        "lon": 4.49182
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/16",
    "value": {
      "city": "Bruges",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 51.20892,
        "lon": 3.22424
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/17",
    "value": {
      "city": "Brussels",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 50.85045,
        "lon": 4.34878
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/18",
    "value": {
      "city": "Edegem",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 51.15662,
        "lon": 4.44504
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/19",
    "value": {
      "city": "Ghent",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 51.05,
        "lon": 3.71667
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/20",
    "value": {
      "city": "Hasselt",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 50.93106,
        "lon": 5.33781
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/21",
    "value": {
      "city": "Liège",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 50.63373,
        "lon": 5.56749
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/22",
    "value": {
      "city": "Turnhout",
      "status": "RECRUITING",
      "country": "Belgium",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 51.32254,
        "lon": 4.94471
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/23",
    "value": {
      "city": "Barretos",
      "status": "NOT_YET_RECRUITING",
      "country": "Brazil",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -20.55722,
        "lon": -48.56778
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/24",
    "value": {
      "city": "Goiânia",
      "status": "NOT_YET_RECRUITING",
      "country": "Brazil",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -16.67861,
        "lon": -49.25389
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/25",
    "value": {
      "city": "Londrina",
      "status": "NOT_YET_RECRUITING",
      "country": "Brazil",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -23.31028,
        "lon": -51.16278
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/26",
    "value": {
      "city": "Porto Alegre",
      "status": "NOT_YET_RECRUITING",
      "country": "Brazil",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -30.03283,
        "lon": -51.23019
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/27",
    "value": {
      "city": "Recife",
      "status": "NOT_YET_RECRUITING",
      "country": "Brazil",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -8.05389,
        "lon": -34.88111
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/28",
    "value": {
      "city": "Salvador",
      "status": "NOT_YET_RECRUITING",
      "country": "Brazil",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -12.97563,
        "lon": -38.49096
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/29",
    "value": {
      "city": "São Paulo",
      "status": "NOT_YET_RECRUITING",
      "country": "Brazil",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -23.5475,
        "lon": -46.63611
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/30",
    "value": {
      "city": "Antofagasta",
      "status": "NOT_YET_RECRUITING",
      "country": "Chile",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -23.65094,
        "lon": -70.39752
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/31",
    "value": {
      "city": "Santiago",
      "status": "NOT_YET_RECRUITING",
      "country": "Chile",
      "facility": "Research Site",
      "geoPoint": {
        "lat": -33.45694,
        "lon": -70.64827
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/32",
    "value": {
      "city": "Antioquia",
      "status": "NOT_YET_RECRUITING",
      "country": "Colombia",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 4.6,
        "lon": -74.4
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/33",
    "value": {
      "city": "Bogotá",
      "status": "NOT_YET_RECRUITING",
      "country": "Colombia",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 4.60971,
        "lon": -74.08175
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/34",
    "value": {
      "city": "Cali",
      "status": "NOT_YET_RECRUITING",
      "country": "Colombia",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 3.43054,
        "lon": -76.5199
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/35",
    "value": {
      "city": "Brno",
      "status": "RECRUITING",
      "country": "Czechia",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 49.19522,
        "lon": 16.60796
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/36",
    "value": {
      "city": "Pardubice",
      "status": "RECRUITING",
      "country": "Czechia",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 50.04075,
        "lon": 15.77659
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/37",
    "value": {
      "city": "Prague",
      "status": "RECRUITING",
      "country": "Czechia",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 50.08804,
        "lon": 14.42076
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/38",
    "value": {
      "city": "Praha-2",
      "status": "RECRUITING",
      "country": "Czechia",
      "facility": "Research Site"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/39",
    "value": {
      "city": "Tábor",
      "status": "RECRUITING",
      "country": "Czechia",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 49.41441,
        "lon": 14.6578
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/40",
    "value": {
      "city": "Budapest",
      "status": "NOT_YET_RECRUITING",
      "country": "Hungary",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 47.49835,
        "lon": 19.04045
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/41",
    "value": {
      "city": "Kecskemét",
      "status": "NOT_YET_RECRUITING",
      "country": "Hungary",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 46.90618,
        "lon": 19.69128
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/42",
    "value": {
      "city": "Nyíregyháza",
      "status": "RECRUITING",
      "country": "Hungary",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 47.95539,
        "lon": 21.71671
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/43",
    "value": {
      "city": "Székesfehérvár",
      "status": "RECRUITING",
      "country": "Hungary",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 47.18995,
        "lon": 18.41034
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/44",
    "value": {
      "city": "Bhopal",
      "status": "NOT_YET_RECRUITING",
      "country": "India",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 23.25469,
        "lon": 77.40289
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/45",
    "value": {
      "city": "Hyderabad",
      "status": "NOT_YET_RECRUITING",
      "country": "India",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 17.38405,
        "lon": 78.45636
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/46",
    "value": {
      "city": "Jaipur",
      "status": "NOT_YET_RECRUITING",
      "country": "India",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 26.91962,
        "lon": 75.78781
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/47",
    "value": {
      "city": "Mumbai",
      "status": "NOT_YET_RECRUITING",
      "country": "India",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 19.07283,
        "lon": 72.88261
      }
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/48",
    "value": {
      "city": "New Delhi",
      "status": "NOT_YET_RECRUITING",
      "country": "India",
      "facility": "Research Site",
      "geoPoint": {
        "lat": 28.62137,
        "lon": 77.2148
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