NCT04482309

A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors

Version 27 to 28 · AstraZeneca

Patch inspector

Version 27 to 28

18 operations 6 path groups ctgov_internal_history

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

enrollment_count_changeenrollment_type_changeprimary_outcome_any_changesecondary_outcome_any_change

Value signals

[
  {
    "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": "2023-06-08",
    "old_value": "2023-06-16",
    "delta_days": 8,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "signal": "milestone_realized",
    "category": "milestone_realized",
    "new_date": "2023-06-08",
    "new_type": "ACTUAL",
    "old_date": "2023-06-16",
    "old_type": "ESTIMATED",
    "severity": "low",
    "delta_days": 8,
    "date_struct": "primaryCompletionDateStruct"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_major_slip",
    "category": "timeline_major_slip",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "high",
    "direction": "later",
    "new_value": "2027-03-31",
    "old_value": "2023-06-16",
    "delta_days": 1384,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "day"
  },
  {
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "signal": "enrollment_count_change_ge_20pct",
    "category": "enrollment_change",
    "severity": "high",
    "new_value": 468,
    "old_value": 268,
    "pct_change": 0.7463
  }
]

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 19:00:24+00
Raw hash: 61ca25e90f2801f7af71088515fa5aff47c133850076f795223ee5625e913a86
Payload: Source URL

Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 1 ops

replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame

Triage: Critical

Primary Outcome Change Operation 11

Matched rules

primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.

Before

An average of approximately 12 months

After

An average of approximately 41 months

Design Trial model, phase, allocation, masking, arms, or interventions. Triage: High 2 ops

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

After

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

ACTUAL

After

ESTIMATED

Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 7 ops

replace /protocolSection/outcomesModule/secondaryOutcomes/0/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

An average of approximately 18 months

After

An average of approximately 41 months

replace /protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame

Triage: High

Secondary Outcome Change Operation 13

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

An average of approximately 18 months

After

An average of approximately 41 months

replace /protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame

Triage: High

Secondary Outcome Change Operation 14

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

An average of approximately 18 months

After

An average of approximately 41 months

replace /protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame

Triage: High

Secondary Outcome Change Operation 15

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

An average of approximately 30 months

After

An average of approximately 41 months

replace /protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame

Triage: High

Secondary Outcome Change Operation 16

Matched rules

secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.

Before

An average of approximately 24 months

After

An average of approximately 41 months

replace /protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame

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

An average of approximately 24 months

After

An average of approximately 41 months

replace /protocolSection/outcomesModule/secondaryOutcomes/8/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.

Before

An average of approximately 24 months

After

An average of approximately 41 months

Timeline Start, primary completion, and completion date movement. Triage: Medium 3 ops

replace /protocolSection/statusModule/primaryCompletionDateStruct/date

Triage: Medium

Timeline Shift Operation 3

Matched rules

primary_completion_timeline_change Primary completion date changes are operational timeline signals.

Before

2023-06-16

After

2023-06-08

replace /protocolSection/statusModule/primaryCompletionDateStruct/type

Triage: Medium

Timeline Shift Operation 4

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 5

Matched rules

completion_timeline_change Completion date changes are operational timeline signals.

Before

2023-06-16

After

2027-03-31

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

2023-02

After

2023-07

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 6

Before

2023-02-22

After

2023-07-07

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 7

Before

2023-02-23

After

2023-07-10

replace /protocolSection/descriptionModule/briefSummary

Triage: Uncategorized

Uncategorized Operation 8

Before

<p>This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.</p><p>This study will enroll 7 tumor-specific cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.</p><p>Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.</p>

After

<p>This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.</p><p>This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.</p><p>Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.</p>

Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 1 ops

add /protocolSection/identificationModule/secondaryIdInfos

Triage: Uncategorized

Uncategorized Operation 1

After

[
  {
    "id": "2020-001574-29",
    "type": "EUDRACT_NUMBER"
  }
]

Raw JSON Patch

[
  {
    "op": "add",
    "path": "/protocolSection/identificationModule/secondaryIdInfos",
    "value": [
      {
        "id": "2020-001574-29",
        "type": "EUDRACT_NUMBER"
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2023-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2023-06-08"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2027-03-31"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-07-07"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-07-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "<p>This is an open-label, multi-center, multi-cohort, Phase 2 study to evaluate the efficacy and safety of trastuzumab deruxtecan (T-DXd) for the treatment of selected HER2-expressing tumors.</p><p>This study will enroll 7 cohorts: urothelial bladder cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors.</p><p>Study hypothesis: Trastuzumab deruxtecan will show meaningful clinical activity and a favorable risk benefit profile in selected HER2-expressing solid tumors.</p>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 468
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ESTIMATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "An average of approximately 41 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "An average of approximately 41 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "An average of approximately 41 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "An average of approximately 41 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "An average of approximately 41 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
    "value": "An average of approximately 41 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
    "value": "An average of approximately 41 months"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
    "value": "An average of approximately 41 months"
  }
]