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NCT03584009

A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy

Version 23 to 24 · Hoffmann-La Roche

Patch inspector

Version 23 to 24

24 operations 5 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
[
  {
    "paths": [
      "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
      "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit",
      "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
      "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame"
    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:59:52+00
Raw hash
3d385a2649bcfa49670e1fd74f817dc5e2e3eb28b05d0b31f4adcf8d000c13ae
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 2 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 6
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Randomization through till 6 months after the last participant is enrolled into the study.
After
Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months).
remove /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
Triage: Critical
Primary Outcome Change Operation 7
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 5 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame
Triage: High
Secondary Outcome Change Operation 8
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Randomization through till 6 months after the last participant is enrolled into the study.
After
Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months).
replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame
Triage: High
Secondary Outcome Change Operation 9
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Randomization through till 6 months after the last participant is enrolled into the study.
After
Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months).
remove /protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit
Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame
Triage: High
Secondary Outcome Change Operation 11
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Time from first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled into the study.
After
Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months).
replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame
Triage: High
Secondary Outcome Change Operation 12
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later).
After
Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months).
Adverse events and safety Posted serious or other adverse event data. Triage: Uncategorized 2 ops
replace /resultsSection/adverseEventsModule/timeFrame
Triage: Uncategorized
Uncategorized Operation 22
Before
Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later).
After
Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months).
remove /resultsSection/adverseEventsModule/reviewUnit
Triage: Uncategorized
Uncategorized Operation 23
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 6 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2021-07
After
2021-08
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2021-07-20
After
2021-08-31
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2021-08-12
After
2021-09-27
add /protocolSection/statusModule/resultsFirstSubmitQcDate
Triage: Uncategorized
Uncategorized Operation 4
After
2021-08-31
add /protocolSection/statusModule/resultsFirstPostDateStruct
Triage: Uncategorized
Uncategorized Operation 5
After
{
  "date": "2021-09-27",
  "type": "ACTUAL"
}
remove /annotationSection
Triage: Uncategorized
Uncategorized Operation 24
Before
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2021-08-11",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "Hoffmann-La Roche"
    }
  }
}
Results outcome measures Posted result outcome measures and result-level endpoint data. Triage: Uncategorized 9 ops
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame
Triage: Uncategorized
Uncategorized Operation 13
Before
Randomization through till 6 months after the last participant is enrolled into the study.
After
Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months).
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit
Triage: Uncategorized
Uncategorized Operation 14
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame
Triage: Uncategorized
Uncategorized Operation 15
Before
Randomization through till 6 months after the last participant is enrolled into the study.
After
Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months).
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame
Triage: Uncategorized
Uncategorized Operation 16
Before
Randomization through till 6 months after the last participant is enrolled into the study.
After
Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months).
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit
Triage: Uncategorized
Uncategorized Operation 17
Before
{
  "resetReasons": [
    "There does not appear to be sufficient information to understand the Time Frame."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame
Triage: Uncategorized
Uncategorized Operation 18
Before
Time from first occurrence of a documented objective response to the time of the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled into the study.
After
Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months).
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment
Triage: Uncategorized
Uncategorized Operation 19
Before
0 participants had a documented objective response (i.e.
CR or PR) so Median, Lower and Upper Limit values could not be estimated.
After
Insufficient number of participants meant that Median, Lower Limit and Upper Limit values could not be estimated.
remove /resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit
Triage: Uncategorized
Uncategorized Operation 20
Before
{
  "resetReasons": [
    "The explanation provided is not sufficient to understand why one or more values are not available."
  ]
}
replace /resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame
Triage: Uncategorized
Uncategorized Operation 21
Before
Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later).
After
Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months).
Raw JSON Patch
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2021-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2021-08-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2021-09-27"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
    "value": "2021-08-31"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
    "value": {
      "date": "2021-09-27",
      "type": "ACTUAL"
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months)."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
    "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
    "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
    "value": "Randomization through till 6 months after the last participant is enrolled into the study (up to approximately 23 months)."
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
    "value": "Time from first occurrence of a documented objective response to the first documented disease progression or death from any cause, whichever occurs first, until 6 months after the last participant is enrolled in the study (up to approximately 23 months)."
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/classes/0/categories/0/measurements/0/comment",
    "value": "Insufficient number of participants meant that Median, Lower Limit and Upper Limit values could not be estimated."
  },
  {
    "op": "remove",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/measureCategoriesReviewUnit"
  },
  {
    "op": "replace",
    "path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
    "value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months)."
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/timeFrame",
    "value": "Baseline up until 28 days after the last dose of study drug (venetoclax or fulvestrant, whichever is later) (up to approximately 23 months)."
  },
  {
    "op": "remove",
    "path": "/resultsSection/adverseEventsModule/reviewUnit"
  },
  {
    "op": "remove",
    "path": "/annotationSection"
  }
]