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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 4 to 5 · AstraZeneca

Patch inspector

Version 4 to 5

18 operations 6 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
arms_or_interventions_changedesign_info_changeenrollment_count_changeenrollment_type_changeprimary_outcome_any_changesecondary_outcome_any_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/completionDateStruct",
    "reason": "date_unparsed_or_missing",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ESTIMATED",
    "old_type": null,
    "severity": "medium",
    "direction": "unknown",
    "new_value": "2009-04",
    "old_value": null,
    "date_struct": "completionDateStruct"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:58+00
Raw hash
8b669a42c3fa644105bec8ea6cda2c1d9f7afb77b43a93c5dffa14e851eea07c
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 2 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 15
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Time To Progression (TTP) after 632 progression events.
After
Time To Progression (TTP)
add /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 16
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
assessed after 632 progression events
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 8 ops
replace /protocolSection/designModule/designInfo/maskingInfo/masking
Triage: High
Design Change Operation 7
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
Before
DOUBLE
After
QUADRUPLE
add /protocolSection/designModule/designInfo/maskingInfo/whoMasked
Triage: High
Design Change Operation 8
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
[
  "PARTICIPANT",
  "CARE_PROVIDER",
  "INVESTIGATOR",
  "OUTCOMES_ASSESSOR"
]
replace /protocolSection/designModule/enrollmentInfo/count
Triage: High
Enrollment Change Operation 9
Matched rules
  • enrollment_count_change Enrollment count changes can signal scope or feasibility shifts.
Before
720
After
736
replace /protocolSection/designModule/enrollmentInfo/type
Triage: High
Enrollment Change Operation 10
Matched rules
  • enrollment_type_change Enrollment type changes from anticipated to actual or similar are high review priority.
Before
ESTIMATED
After
ACTUAL
add /protocolSection/armsInterventionsModule/interventions/0/description
Triage: High
Arm Intervention Change Operation 11
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
intramuscular injection 250 mg & 500 mg
add /protocolSection/armsInterventionsModule/interventions/0/armGroupLabels
Triage: High
Arm Intervention Change Operation 12
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "1",
  "2"
]
add /protocolSection/armsInterventionsModule/interventions/0/otherNames
Triage: High
Arm Intervention Change Operation 13
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  "Faslodex",
  "ZD9238"
]
add /protocolSection/armsInterventionsModule/armGroups
Triage: High
Arm Intervention Change Operation 14
Matched rules
  • arms_or_interventions_change Arms or interventions changes can alter treatment/comparator structure.
After
[
  {
    "type": "EXPERIMENTAL",
    "label": "1",
    "description": "Fulvestrant 500 mg",
    "interventionNames": [
      "Drug: Fulvestrant"
    ]
  },
  {
    "type": "EXPERIMENTAL",
    "label": "2",
    "description": "Fulvestrant 250 mg",
    "interventionNames": [
      "Drug: Fulvestrant"
    ]
  }
]
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 2 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 17
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Objective Response, Clinical Benefit Rate, Duration of Response, Duration of Clinical Benefit, Overall survival, Quality of Life. All derived after 632 progression events.
After
Objective Response, Clinical Benefit Rate, Duration of Response, Duration of Clinical Benefit, Overall survival, Quality of Life
add /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 18
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
After
assessed after 632 progression events
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
add /protocolSection/statusModule/completionDateStruct
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
After
{
  "date": "2009-04",
  "type": "ESTIMATED"
}
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
2007-02
After
2007-12
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
Before
2007-10-29
After
2007-12-14
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 5
Before
2007-10-31
After
2007-12-18
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
CONFIRM - A Comparison 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
Comparison of Fulvestrant (FASLODEX™) 250 mg and 500mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.
add /protocolSection/identificationModule/acronym
Triage: Uncategorized
Uncategorized Operation 2
After
CONFIRM
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "Comparison of Fulvestrant (FASLODEX™) 250 mg and 500mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy."
  },
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/acronym",
    "value": "CONFIRM"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2007-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2007-12-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2007-12-18"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/completionDateStruct",
    "value": {
      "date": "2009-04",
      "type": "ESTIMATED"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/designInfo/maskingInfo/masking",
    "value": "QUADRUPLE"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/maskingInfo/whoMasked",
    "value": [
      "PARTICIPANT",
      "CARE_PROVIDER",
      "INVESTIGATOR",
      "OUTCOMES_ASSESSOR"
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 736
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/description",
    "value": "intramuscular injection 250 mg & 500 mg"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels",
    "value": [
      "1",
      "2"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
    "value": [
      "Faslodex",
      "ZD9238"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups",
    "value": [
      {
        "type": "EXPERIMENTAL",
        "label": "1",
        "description": "Fulvestrant 500 mg",
        "interventionNames": [
          "Drug: Fulvestrant"
        ]
      },
      {
        "type": "EXPERIMENTAL",
        "label": "2",
        "description": "Fulvestrant 250 mg",
        "interventionNames": [
          "Drug: Fulvestrant"
        ]
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Time To Progression (TTP)"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "assessed after 632 progression events"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Objective Response, Clinical Benefit Rate, Duration of Response, Duration of Clinical Benefit, Overall survival, Quality of Life"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "assessed after 632 progression events"
  }
]