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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 0 to 1 · AstraZeneca

Patch inspector

Version 0 to 1

10 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
design_info_change
Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct",
    "reason": "date_unparsed_or_missing",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": null,
    "old_type": null,
    "severity": "medium",
    "direction": "unknown",
    "new_value": "2005-08",
    "old_value": null,
    "date_struct": "startDateStruct"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:57+00
Raw hash
32269ba3be9ba82adafb25f6e58429673ccc6de094caab6e9bd99fbf26b7b8da
Payload
Source URL
Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 4 ops
add /protocolSection/designModule/designInfo/allocation
Triage: High
Design Change Operation 6
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
RANDOMIZED
add /protocolSection/designModule/designInfo/interventionModel
Triage: High
Design Change Operation 7
Matched rules
  • design_info_change Design information changes can alter allocation, masking, model, or purpose and need review.
After
PARALLEL
add /protocolSection/designModule/designInfo/maskingInfo
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
{
  "masking": "DOUBLE"
}
add /protocolSection/designModule/enrollmentInfo
Triage: Uncategorized
Uncategorized Operation 9
After
{
  "count": 720
}
Timeline Start, primary completion, and completion date movement. Triage: Medium 1 ops
add /protocolSection/statusModule/startDateStruct
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
After
{
  "date": "2005-08"
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2005-06
After
2005-08
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 3
Before
2005-06-23
After
2005-08-22
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 4
Before
2005-06-24
After
2005-08-23
add /protocolSection/outcomesModule
Triage: Uncategorized
Uncategorized Operation 10
After
{
  "primaryOutcomes": [
    {
      "measure": "Time To Progression (TTP) after 632 progression events."
    }
  ],
  "secondaryOutcomes": [
    {
      "measure": "Objective Response, Clinical Benefit Rate, Duration of Response, Duration of Clinical Benefit, Overall survival, Quality of Life. All derived after 632 progression events."
    }
  ]
}
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops
replace /protocolSection/identificationModule/briefTitle
Triage: Uncategorized
Uncategorized Operation 1
Before
A Comparison of the Efficacy and Tolerability of Fulvestrant (FASLODEX™) in Women with Breast Cancer
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.
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/statusModule/statusVerifiedDate",
    "value": "2005-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2005-08-22"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2005-08-23"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/startDateStruct",
    "value": {
      "date": "2005-08"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/allocation",
    "value": "RANDOMIZED"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/interventionModel",
    "value": "PARALLEL"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/maskingInfo",
    "value": {
      "masking": "DOUBLE"
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/enrollmentInfo",
    "value": {
      "count": 720
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule",
    "value": {
      "primaryOutcomes": [
        {
          "measure": "Time To Progression (TTP) after 632 progression events."
        }
      ],
      "secondaryOutcomes": [
        {
          "measure": "Objective Response, Clinical Benefit Rate, Duration of Response, Duration of Clinical Benefit, Overall survival, Quality of Life. All derived after 632 progression events."
        }
      ]
    }
  }
]