Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer

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    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
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    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
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    "value": "<p>Primary endpoint number 1 : DLT analysis.</p><p>DLT analysis (one of the two primary endpoints) was conducted only on the 6 first patients of Arm A (Pembrolizumab Arm, 6 first patients out of the 33 included in Arm A. Zero patient out of the 19 patients included in Arm B were included in DLT analysis.)</p>"
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    "op": "replace",
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    "value": "Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)"
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    "value": "defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0&#x2F;is, ypN0 in the current AJCC staging system)"
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    "op": "replace",
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    "op": "replace",
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        {
          "id": "OG000",
          "title": "Pembrolizumab",
          "description": "<p>EC Paclitaxel + Pembrolizumab Injection</p><p>Pembrolizumab Injection: Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>"
        },
        {
          "id": "OG001",
          "title": "Standard Neoadjuvant Chemotherapy",
          "description": "<p>EC Paclitaxel alone</p><p>neoadjuvant EC-paclitaxel chemotherapy: The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel</p>"
        }
      ],
      "classes": [
        {
          "categories": [
            {
              "measurements": [
                {
                  "value": "0",
                  "groupId": "OG000"
                }
              ]
            }
          ]
        }
      ],
      "paramType": "NUMBER",
      "timeFrame": "during 21 days following the first administration of pembrolizumab",
      "description": "incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed separately in the first 3 patients of each stratum (HR+ and HR-).\nDLTs will be defined according to CTCAE.",
      "unitOfMeasure": "patients",
      "reportingStatus": "POSTED",
      "populationDescription": "only pembrolizumab patients have been analyzed for DLT",
      "measureCategoriesReviewUnit": {
        "resetReasons": [
          "Required information appears to be missing."
        ]
      }
    }
  },
  {
    "op": "replace",
    "path": "/resultsSection/adverseEventsModule/timeFrame",
    "value": "through 30 days after the last dose of study treatment or before the initiation of radiotherapy, whichever comes first. All AEs that occured prior to the Safety Follow-Up Visit were recorded. Patients with an AE of Grade &gt; 1 were followed until the resolution of the AE to Grade 0-1 or until the beginning of a new anti-cancer therapy (excluding the scheduled post-mastectomy treatments), whichever occured first."
  },
  {
    "op": "replace",
    "path": "/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date",
    "value": "2025-12-01"
  },
  {
    "op": "add",
    "path": "/reviewUnit",
    "value": {
      "resetReasons": [
        "Issues noted on a previous submission of this record do not appear to have been addressed."
      ]
    }
  }
]