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NCT03734029

Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

Version 1 to 2 · Daiichi Sankyo

Patch inspector

Version 1 to 2

7 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
contact_admin_change
Value signals

None recorded.

Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:12:42+00
Raw hash
1fab028a4f1bf0282074ce92e323aac81eb816aa16d8eff88c8366ed683f1ae8
Payload
Source URL
Contacts and locations Site, contact, and location updates that are usually operational. Triage: Low 2 ops
add /protocolSection/contactsLocationsModule/centralContacts
Triage: Low
Administrative Contact Change Operation 4
Matched rules
  • contact_admin_change Central contact updates are usually administrative.
After
[
  {
    "name": "(for Asia Sites Only) Daiichi Sankyo Contact for Clinical Trial Information",
    "role": "CONTACT",
    "email": "dsclinicaltrial@daiichisankyo.co.jp",
    "phone": "+81-3-6225-1111 (M-F 9-5 JST)"
  }
]
add /protocolSection/contactsLocationsModule/locations
Triage: Uncategorized
Uncategorized Operation 5
After
[
  {
    "zip": "75234",
    "city": "Dallas",
    "state": "Texas",
    "status": "RECRUITING",
    "country": "United States",
    "contacts": [
      {
        "name": "Principal Investigator",
        "role": "CONTACT",
        "email": "birenbaum.bloomtrials@gmail.com",
        "phone": "800-527-6266"
      }
    ],
    "facility": "BloomTrials Clinical Research, LLC",
    "geoPoint": {
      "lat": 32.78306,
      "lon": -96.80667
    }
  },
  {
    "zip": "730-8518",
    "city": "Hiroshima",
    "state": "Hiroshima",
    "status": "RECRUITING",
    "country": "Japan",
    "contacts": [
      {
        "name": "See Central Contact",
        "role": "CONTACT"
      }
    ],
    "facility": "Hiroshima City Hiroshima Citizens Hospital",
    "geoPoint": {
      "lat": 34.4,
      "lon": 132.45
    }
  }
]
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 4 ops
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2018-12-13
After
2018-12-19
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2018-12-17
After
2018-12-21
replace /protocolSection/ipdSharingStatementModule/description
Triage: Uncategorized
Uncategorized Operation 6
Before
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://www.clinicalstudydatarequest.com//.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx
After
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.
In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.
Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
replace /protocolSection/ipdSharingStatementModule/url
Triage: Uncategorized
Uncategorized Operation 7
Before
https://www.clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-DS.aspx
After
https://vivli.org/ourmember/daiichi-sankyo/
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 1
Before
NOT_YET_RECRUITING
After
RECRUITING
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-12-19"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-12-21"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/centralContacts",
    "value": [
      {
        "name": "(for Asia Sites Only) Daiichi Sankyo Contact for Clinical Trial Information",
        "role": "CONTACT",
        "email": "dsclinicaltrial@daiichisankyo.co.jp",
        "phone": "+81-3-6225-1111 (M-F 9-5 JST)"
      }
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations",
    "value": [
      {
        "zip": "75234",
        "city": "Dallas",
        "state": "Texas",
        "status": "RECRUITING",
        "country": "United States",
        "contacts": [
          {
            "name": "Principal Investigator",
            "role": "CONTACT",
            "email": "birenbaum.bloomtrials@gmail.com",
            "phone": "800-527-6266"
          }
        ],
        "facility": "BloomTrials Clinical Research, LLC",
        "geoPoint": {
          "lat": 32.78306,
          "lon": -96.80667
        }
      },
      {
        "zip": "730-8518",
        "city": "Hiroshima",
        "state": "Hiroshima",
        "status": "RECRUITING",
        "country": "Japan",
        "contacts": [
          {
            "name": "See Central Contact",
            "role": "CONTACT"
          }
        ],
        "facility": "Hiroshima City Hiroshima Citizens Hospital",
        "geoPoint": {
          "lat": 34.4,
          "lon": 132.45
        }
      }
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/ipdSharingStatementModule/description",
    "value": "De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/.\nIn cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants.\nDetails on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/"
  },
  {
    "op": "replace",
    "path": "/protocolSection/ipdSharingStatementModule/url",
    "value": "https://vivli.org/ourmember/daiichi-sankyo/"
  }
]