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NCT00629616

Efficacy of Anastrozole and Fulvestrant in Patients With ER Positive, HER2 Negative, Operable Breast Cancer

Version 10 to 11 · UNICANCER

Patch inspector

Version 10 to 11

15 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

None recorded.

Value signals
[
  {
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "signal": "timeline_shift",
    "category": "timeline_shift",
    "new_type": "ACTUAL",
    "old_type": null,
    "severity": "medium",
    "direction": "later",
    "new_value": "2007-10",
    "old_value": "2007-08",
    "delta_days": 61,
    "date_struct": "startDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_actualized_earlier",
    "category": "timeline_actualized_earlier",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "earlier",
    "new_value": "2015-06",
    "old_value": "2016-09",
    "delta_days": 458,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ACTUAL",
    "old_type": "ESTIMATED",
    "severity": "high",
    "direction": "later",
    "new_value": "2018-04",
    "old_value": "2016-09",
    "delta_days": 577,
    "date_struct": "completionDateStruct",
    "new_precision": "month",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:00:51+00
Raw hash
8ec49d80209c9b8ab08960889e7a0fb558e5b68477954a5db342ed2a268d6b0a
Payload
Source URL
Timeline Start, primary completion, and completion date movement. Triage: Medium 6 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 3
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2007-08
After
2007-10
add /protocolSection/statusModule/startDateStruct/type
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
After
ACTUAL
replace /protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Medium
Timeline Shift Operation 5
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
2016-09
After
2015-06
replace /protocolSection/statusModule/primaryCompletionDateStruct/type
Triage: Medium
Timeline Shift Operation 6
Matched rules
  • primary_completion_timeline_change Primary completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 7
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2016-09
After
2018-04
replace /protocolSection/statusModule/completionDateStruct/type
Triage: Medium
Timeline Shift Operation 8
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
ESTIMATED
After
ACTUAL
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2014-08
After
2021-06
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 9
Before
2014-08-05
After
2021-06-04
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 10
Before
2014-08-06
After
2021-06-09
replace /protocolSection/statusModule/lastUpdatePostDateStruct/type
Triage: Uncategorized
Uncategorized Operation 11
Before
ESTIMATED
After
ACTUAL
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 4 ops
add /protocolSection/oversightModule/isFdaRegulatedDrug
Triage: Uncategorized
Uncategorized Operation 12
After
false
add /protocolSection/oversightModule/isFdaRegulatedDevice
Triage: Uncategorized
Uncategorized Operation 13
After
false
add /protocolSection/referencesModule/references/0
Triage: Uncategorized
Uncategorized Operation 14
After
{
  "pmid": "27315583",
  "type": "RESULT",
  "citation": "Lerebours F, Rivera S, Mouret-Reynier MA, Alran S, Venat-Bouvet L, Kerbrat P, Salmon R, Becette V, Bourgier C, Cherel P, Boussion V, Balleyguier C, Thibault F, Lavau-Denes S, Nabholz JM, Sigal B, Trassard M, Mathieu MC, Martin AL, Lemonnier J, Mouret-Fourme E. Randomized phase 2 neoadjuvant trial evaluating anastrozole and fulvestrant efficacy for postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients: Results of the UNICANCER CARMINA 02 French trial (UCBG 0609). Cancer. 2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143. Epub 2016 Jun 17."
}
add /protocolSection/referencesModule/seeAlsoLinks
Triage: Uncategorized
Uncategorized Operation 15
After
[
  {
    "url": "https://pubmed.ncbi.nlm.nih.gov/27315583/",
    "label": "Cancer .\n2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143.\nEpub 2016 Jun 17."
  }
]
Status and stopping reason Recruitment status, termination, suspension, withdrawal, or why-stopped text. Triage: Uncategorized 1 ops
replace /protocolSection/statusModule/overallStatus
Triage: Uncategorized
Uncategorized Operation 2
Before
ACTIVE_NOT_RECRUITING
After
COMPLETED
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2021-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "COMPLETED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2007-10"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2015-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2018-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2021-06-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2021-06-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDrug",
    "value": false
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDevice",
    "value": false
  },
  {
    "op": "add",
    "path": "/protocolSection/referencesModule/references/0",
    "value": {
      "pmid": "27315583",
      "type": "RESULT",
      "citation": "Lerebours F, Rivera S, Mouret-Reynier MA, Alran S, Venat-Bouvet L, Kerbrat P, Salmon R, Becette V, Bourgier C, Cherel P, Boussion V, Balleyguier C, Thibault F, Lavau-Denes S, Nabholz JM, Sigal B, Trassard M, Mathieu MC, Martin AL, Lemonnier J, Mouret-Fourme E. Randomized phase 2 neoadjuvant trial evaluating anastrozole and fulvestrant efficacy for postmenopausal, estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients: Results of the UNICANCER CARMINA 02 French trial (UCBG 0609). Cancer. 2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143. Epub 2016 Jun 17."
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/referencesModule/seeAlsoLinks",
    "value": [
      {
        "url": "https://pubmed.ncbi.nlm.nih.gov/27315583/",
        "label": "Cancer .\n2016 Oct;122(19):3032-40. doi: 10.1002/cncr.30143.\nEpub 2016 Jun 17."
      }
    ]
  }
]