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NCT03025035

Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

Version 0 to 1 · Yuan Yuan

Patch inspector

Version 0 to 1

9 operations 3 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_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": null,
    "severity": "low",
    "direction": "later",
    "new_value": "2017-02-15",
    "old_value": "2017-02",
    "delta_days": 14,
    "date_struct": "startDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "same",
    "new_value": "2019-01-01",
    "old_value": "2019-01",
    "delta_days": 0,
    "date_struct": "primaryCompletionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  },
  {
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "signal": "timeline_minor_adjustment",
    "category": "timeline_minor_adjustment",
    "new_type": "ESTIMATED",
    "old_type": "ESTIMATED",
    "severity": "low",
    "direction": "same",
    "new_value": "2021-01-01",
    "old_value": "2021-01",
    "delta_days": 0,
    "date_struct": "completionDateStruct",
    "new_precision": "day",
    "old_precision": "month"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 18:58:38+00
Raw hash
ba2fbe9858479d8e49e0b4387d6403ad9f634c0075e5ae945b5de8c3b51c8a50
Payload
Source URL
Timeline Start, primary completion, and completion date movement. Triage: Medium 4 ops
replace /protocolSection/statusModule/startDateStruct/date
Triage: Medium
Timeline Shift Operation 1
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
Before
2017-02
After
2017-02-15
add /protocolSection/statusModule/startDateStruct/type
Triage: Medium
Timeline Shift Operation 2
Matched rules
  • start_timeline_change Start date changes are operational timeline signals.
After
ESTIMATED
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
2019-01
After
2019-01-01
replace /protocolSection/statusModule/completionDateStruct/date
Triage: Medium
Timeline Shift Operation 4
Matched rules
  • completion_timeline_change Completion date changes are operational timeline signals.
Before
2021-01
After
2021-01-01
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 3 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 5
Before
2017-01-17
After
2017-01-18
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 6
Before
2017-01-19
After
2017-01-20
replace /protocolSection/descriptionModule/detailedDescription
Triage: Uncategorized
Uncategorized Operation 9
Before
There are two BRCA genes, BRCA1 and BRCA2, and they play a role in protecting cells from cancer.
If one of these genes is mutated, cells may rapidly change and divide, which can lead to cancer.
Pembrolizumab is a drug that works with the immune system to target the tumor (immunotherapy).
We want to know if pembrolizumab will be able to reduce the size and amount of cancer cells with fewer side effects than standard treatment by targeting the tumor.This research study is designed to test the investigational use of pembrolizumab in breast cancer.
After
There are two BRCA genes, BRCA1 and BRCA2, and they play a role in protecting cells from cancer.
If one of these genes is mutated, cells may rapidly change and divide, which can lead to cancer.
Pembrolizumab is a drug that works with the immune system to target the tumor (immunotherapy).
The investigators want to know if pembrolizumab will be able to reduce the size and amount of cancer cells with fewer side effects than standard treatment by targeting the tumor.This research study is designed to test the investigational use of pembrolizumab in breast cancer.
Sponsor and administrative fields Sponsor, collaborator, oversight, or registry maintenance changes. Triage: Uncategorized 2 ops
add /protocolSection/oversightModule/isFdaRegulatedDrug
Triage: Uncategorized
Uncategorized Operation 7
After
true
add /protocolSection/oversightModule/isFdaRegulatedDevice
Triage: Uncategorized
Uncategorized Operation 8
After
false
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2017-02-15"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/startDateStruct/type",
    "value": "ESTIMATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2019-01-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2021-01-01"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2017-01-18"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2017-01-20"
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDrug",
    "value": true
  },
  {
    "op": "add",
    "path": "/protocolSection/oversightModule/isFdaRegulatedDevice",
    "value": false
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "There are two BRCA genes, BRCA1 and BRCA2, and they play a role in protecting cells from cancer.\nIf one of these genes is mutated, cells may rapidly change and divide, which can lead to cancer.\nPembrolizumab is a drug that works with the immune system to target the tumor (immunotherapy).\nThe investigators want to know if pembrolizumab will be able to reduce the size and amount of cancer cells with fewer side effects than standard treatment by targeting the tumor.This research study is designed to test the investigational use of pembrolizumab in breast cancer."
  }
]