{
  "id": "ctis:2025-521385-10-00",
  "euct": "2025-521385-10-00",
  "title": "ENDO-67 project: Investigating ENDOcrine therapy-related questions using Ki67 changes in the window-of-opportunity before breast surgery",
  "publicTitle": "ENDO-67 project: Investigating ENDOcrine therapy-related questions using Ki67 changes in the window-of-opportunity before breast surgery",
  "fullTitle": "ENDO-67 project: Investigating ENDOcrine therapy-related questions using Ki67 changes in the window-of-opportunity before breast surgery",
  "shortTitle": null,
  "status": "Authorised",
  "statusCode": "2",
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  "decisionDate": "2025-10-21T10:58:52.882",
  "publishDate": "2025-10-22T03:31:39.101141607",
  "trialRegion": "EEA",
  "trialRegionCode": "1",
  "medicalConditions": [
    {
      "name": "Breast cancer",
      "rareDisease": false
    }
  ],
  "therapeuticAreas": [
    {
      "code": "4",
      "name": "Diseases [C] - Neoplasms [C04]"
    }
  ],
  "trialCategory": {
    "phaseCode": "6",
    "categoryCode": "3",
    "lowIntervention": true
  },
  "duration": {
    "estimatedRecruitmentStartDate": "2025-11-01",
    "estimatedEndDate": "2030-11-01",
    "estimatedGlobalEndDate": null
  },
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          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-10-20",
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          "isRMS": true
        }
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      "businessKey": "IN",
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      "status": "Authorised",
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      "submissionDate": "2025-07-09",
      "decisionDate": "2025-10-21",
      "decisions": [
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          "mscName": "Netherlands",
          "decisionDate": "2025-10-21T10:58:52.882",
          "decision": "authorized",
          "assessmentOutcome": "acceptable",
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        }
      ],
      "countryStatuses": [
        {
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          "firstDecisionDate": "2025-10-21",
          "assessmentOutcome": "acceptable",
          "assessmentOutcomeDate": "2025-10-20",
          "reportingStatusCode": "Authorised",
          "applicationStatusCode": "Authorised"
        }
      ]
    }
  ],
  "evidence": [
    {
      "id": "evidence:f6f9c3faffda39dcbc921626",
      "path": "authorizedApplication.authorizedPartI.trialDetails.trialInformation.trialObjective.secondaryObjectives[2].secondaryObjective",
      "term": "artificial intelligence",
      "snippet": "What is the concordance between Ki67 percentage measured by the pathologist versus an artificial intelligence (AI) algorithm"
    }
  ],
  "official": {
    "retrieveUrl": "https://euclinicaltrials.eu/ctis-public-api/retrieve/2025-521385-10-00",
    "publicUrl": "https://euclinicaltrials.eu/ctis-public/view/2025-521385-10-00?lang=en"
  },
  "slug": "2025-521385-10-00",
  "firstObservedAt": "2026-07-23T11:19:41.794Z",
  "lastObservedAt": "2026-07-23T13:03:56.000Z",
  "dateModified": "2026-07-23",
  "materialFingerprint": "90e43cd1a9333245a02465b59f5e93be05f1696b2e567bc1906b36c085212195"
}