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NCT03515798

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

Version 5 to 6 · Institut Paoli-Calmettes

Patch inspector

Version 5 to 6

24 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
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    ],
    "signal": "results_reconciliation_outcome_suppression",
    "category": "results_reconciliation",
    "severity": "low"
  }
]
Provenance
Source
ctgov_internal_history
Fetched
2026-06-18 19:14:16+00
Raw hash
b3c9f0f8ab75578d0db5c1d92a90d5ffc6bd121c3c6ccb5d663320a3c32c5d3e
Payload
Source URL
Primary outcomes Outcome measures that define the trial's primary evidence target. Triage: Critical 4 ops
replace /protocolSection/outcomesModule/primaryOutcomes/0/measure
Triage: Critical
Primary Outcome Change Operation 5
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Central evaluation of pathological complete response rate
After
Central Evaluation of Pathological Complete Response Rate
replace /protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Critical
Primary Outcome Change Operation 6
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Following completion of neoadjuvant systemic treatment, an average of 24 weeks
After
end of study
add /protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
Triage: Critical
Primary Outcome Change Operation 7
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
After
{
  "resetReasons": [
    "Required information appears to be missing."
  ]
}
replace /protocolSection/outcomesModule/primaryOutcomes/1/measure
Triage: Critical
Primary Outcome Change Operation 8
Matched rules
  • primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority.
Before
Dose Limiting Toxicity (DLT) rates
After
Dose Limiting Toxicity (DLT) Rates
Secondary outcomes Additional endpoints and outcome descriptions. Triage: High 8 ops
replace /protocolSection/outcomesModule/secondaryOutcomes/0/measure
Triage: High
Secondary Outcome Change Operation 9
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
occurrence of serious adverse events and adverse events starting grade 2 or grade 1 (run-in period)
After
Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)
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Triage: High
Secondary Outcome Change Operation 10
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Local evaluation of pathological complete response rate
After
Local Evaluation of Pathological Complete Response Rate
replace /protocolSection/outcomesModule/secondaryOutcomes/2/measure
Triage: High
Secondary Outcome Change Operation 11
Matched rules
  • secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority.
Before
Invasive disease-free survival (IDFS)
After
Invasive Disease-free Survival (IDFS)
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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
Invasive disease-free survival (IDFS)
After
Invasive Disease-free Survival (IDFS)
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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
Event free survival (EFS)
After
Event Free Survival (EFS)
replace /protocolSection/outcomesModule/secondaryOutcomes/5/measure
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
Event free survival (EFS)
After
Event Free Survival (EFS)
replace /protocolSection/outcomesModule/secondaryOutcomes/6/measure
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
Overall survival (OS)
After
Overall Survival (OS)
replace /protocolSection/outcomesModule/secondaryOutcomes/7/measure
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
Overall survival (OS)
After
Overall Survival (OS)
Other registry fields Changes outside the current high-signal rule families. Triage: Uncategorized 12 ops
replace /protocolSection/statusModule/statusVerifiedDate
Triage: Uncategorized
Uncategorized Operation 1
Before
2025-09
After
2025-10
replace /protocolSection/statusModule/lastUpdateSubmitDate
Triage: Uncategorized
Uncategorized Operation 2
Before
2025-09-05
After
2025-10-24
replace /protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Uncategorized
Uncategorized Operation 3
Before
2025-09-12
After
2025-11-10
add /protocolSection/statusModule/resultsFirstSubmitDate
Triage: Uncategorized
Uncategorized Operation 4
After
2025-10-24
replace /protocolSection/outcomesModule/otherOutcomes/0/measure
Triage: Uncategorized
Uncategorized Operation 17
Before
Evaluation of PD-L1 expression in pre, per and post-treatment tissue
After
Evaluation of PD-L1 Expression in Pre, Per and Post-treatment Tissue
replace /protocolSection/outcomesModule/otherOutcomes/1/measure
Triage: Uncategorized
Uncategorized Operation 18
Before
Measurement of baseline Circulating tumor cells for prospective validation of their prognostic value in IBC
After
Measurement of Baseline Circulating Tumor Cells for Prospective Validation of Their Prognostic Value in IBC
replace /protocolSection/outcomesModule/otherOutcomes/2/measure
Triage: Uncategorized
Uncategorized Operation 19
Before
Disease monitoring
After
Disease Monitoring
replace /protocolSection/outcomesModule/otherOutcomes/3/measure
Triage: Uncategorized
Uncategorized Operation 20
Before
Identification of mechanisms of treatment resistance
After
Identification of Mechanisms of Treatment Resistance
replace /hasResults
Triage: Uncategorized
Uncategorized Operation 21
Before
false
After
true
add /resultsSection
Triage: Uncategorized
Uncategorized Operation 22
After
{
  "moreInfoModule": {
    "pointOfContact": {
      "email": "drci.up@ipc.unicancer.fr",
      "phone": "+33491223778",
      "title": "Anthony GONCALVES",
      "organization": "Instutut Paoli-Calmettes"
    },
    "certainAgreement": {
      "piSponsorEmployee": true
    }
  },
  "adverseEventsModule": {
    "timeFrame": "from the time of treatment randomization through 30 days following cessation of study treat-ment",
    "reviewUnit": {
      "resetReasons": [
        "There does not appear to be sufficient information to understand the Time Frame."
      ]
    },
    "description": "This study only recorded AEs related to the investigational product, unlike ClinicalTrials.gov\nwhich includes all events.\nAEs were collected via active surveillance from all treated participants during the treatment period.",
    "eventGroups": [
      {
        "id": "EG000",
        "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>",
        "otherNumAtRisk": 6,
        "deathsNumAtRisk": 6,
        "otherNumAffected": 6,
        "seriousNumAtRisk": 6,
        "deathsNumAffected": 0,
        "seriousNumAffected": 2
      },
      {
        "id": "EG001",
        "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>",
        "otherNumAtRisk": 0,
        "deathsNumAtRisk": 0,
        "otherNumAffected": 0,
        "seriousNumAtRisk": 0,
        "deathsNumAffected": 0,
        "seriousNumAffected": 0
      }
    ],
    "otherEvents": [
      {
        "term": "ANEMIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 4
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "HYPERTHYROIDISM",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Endocrine disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "ASTHENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "MUCOSAL INFLAMMATION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "GAMMA-GLUTAMYLTRANSFERASE INCREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 3
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "NEUTROPHIL COUNT DECREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 3
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "WHITE BLOOD CELL COUNT DECREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 3
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "HEADACHE",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "ALOPECIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 3
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "HYPERTENSION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "CONSTIPATION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "NAUSEA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 5
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "FATIGUE",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "URINARY TRACT INFECTION",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Infections and infestations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "LYMPHOCYTE COUNT DECREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 3
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "GASTROINTESTINAL TOXICITY",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "PYREXIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "STOMATITIS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "DIARRHEA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "REFLUX GASTRITIS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "BLOOD ALKALINE PHOSPHATASE INCREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "HAEMATOCRIT DECREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "NEUTROPHIL COUNT INCREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "RASH",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "PALPITATIONS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Cardiac disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "ABDOMINAL PAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "OEDEMA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "WEIGHT GAIN",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "WEIGHT LOSS",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "DECREASED APPETITE",
        "notes": "ANOREXIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "DYSGEUSIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "PERIPHERAL SENSORY NEUROPATHY",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Nervous system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "INSOMNIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 2
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Psychiatric disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "COUGH",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Respiratory, thoracic and mediastinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "ACNEA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "ERYTHEMA",
        "notes": "BREAST ERYTHEMA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "RASH MACULO-PAPULAR",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Skin and subcutaneous tissue disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "HOT FLUSH",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Vascular disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "FEBRILE NEUTROPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "LEUKOPENIA",
        "notes": "LEUCOPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "LYMPHOPENIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Blood and lymphatic system disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "BLOOD LACTATE DEHYDROGENASE INCREASED",
        "notes": "LACTATE DEHYDROGENASE INCREASED",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Investigations",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "HYPERKALAEMIA",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Metabolism and nutrition disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      }
    ],
    "seriousEvents": [
      {
        "term": "FEVER",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "General disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      },
      {
        "term": "VOMITING",
        "stats": [
          {
            "groupId": "EG000",
            "numAtRisk": 6,
            "numAffected": 1
          },
          {
            "groupId": "EG001",
            "numAtRisk": 0,
            "numAffected": 0
          }
        ],
        "organSystem": "Gastrointestinal disorders",
        "assessmentType": "SYSTEMATIC_ASSESSMENT"
      }
    ],
    "frequencyThreshold": "0"
  },
  "outcomeMeasuresModule": {
    "outcomeMeasures": [
      {
        "type": "PRIMARY",
        "title": "Central Evaluation of Pathological Complete Response Rate",
        "timeFrame": "end of study",
        "reviewUnit": {
          "resetReasons": [
            "Required information appears to be missing."
          ]
        },
        "description": "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)",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants",
        "anticipatedPostingDate": "2027-08"
      },
      {
        "type": "PRIMARY",
        "title": "Dose Limiting Toxicity (DLT) Rates",
        "denoms": [
          {
            "units": "Participants",
            "counts": [
              {
                "value": "6",
                "groupId": "OG000"
              },
              {
                "value": "0",
                "groupId": "OG001"
              }
            ]
          }
        ],
        "groups": [
          {
            "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."
          ]
        }
      },
      {
        "type": "SECONDARY",
        "title": "Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)",
        "timeFrame": "during 21 days following the first administration of pembrolizumab",
        "description": "according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants",
        "anticipatedPostingDate": "2027-08"
      },
      {
        "type": "SECONDARY",
        "title": "Local Evaluation of Pathological Complete Response Rate",
        "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
        "description": "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)",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "SECONDARY",
        "title": "Invasive Disease-free Survival (IDFS)",
        "timeFrame": "3 years",
        "description": "time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "SECONDARY",
        "title": "Invasive Disease-free Survival (IDFS)",
        "timeFrame": "5 years",
        "description": "time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "SECONDARY",
        "title": "Event Free Survival (EFS)",
        "timeFrame": "3 years",
        "description": "time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "SECONDARY",
        "title": "Event Free Survival (EFS)",
        "timeFrame": "5 years",
        "description": "time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "SECONDARY",
        "title": "Overall Survival (OS)",
        "timeFrame": "3 years",
        "description": "time from randomization to death from any cause",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "SECONDARY",
        "title": "Overall Survival (OS)",
        "timeFrame": "5 years",
        "description": "time from randomization to death from any cause",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "OTHER_PRE_SPECIFIED",
        "title": "Evaluation of PD-L1 Expression in Pre, Per and Post-treatment Tissue",
        "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
        "description": "by IHC and mass spectrometry-based proteomics; and in plasma samples using quantitative proteomics,",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "OTHER_PRE_SPECIFIED",
        "title": "Measurement of Baseline Circulating Tumor Cells for Prospective Validation of Their Prognostic Value in IBC",
        "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
        "description": "Measurement of baseline CTC for prospective validation of their prognostic value in IBC",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "OTHER_PRE_SPECIFIED",
        "title": "Disease Monitoring",
        "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
        "description": "Purification of ctDNA and specific sequencing for disease monitoring.",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      },
      {
        "type": "OTHER_PRE_SPECIFIED",
        "title": "Identification of Mechanisms of Treatment Resistance",
        "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
        "description": "Immune profiling, NGS and mouse xenografing for ex-vivo phenotypic approaches on post-treatment residual disease in order to identify mechanisms of resistance.",
        "reportingStatus": "NOT_POSTED",
        "denomUnitsSelected": "Participants"
      }
    ]
  },
  "participantFlowModule": {
    "groups": [
      {
        "id": "FG000",
        "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": "FG001",
        "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>"
      }
    ],
    "periods": [
      {
        "title": "Overall Study",
        "milestones": [
          {
            "type": "STARTED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "6"
              },
              {
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            ]
          },
          {
            "type": "COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "6"
              },
              {
                "groupId": "FG001",
                "numSubjects": "0"
              }
            ]
          },
          {
            "type": "NOT COMPLETED",
            "achievements": [
              {
                "groupId": "FG000",
                "numSubjects": "0"
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              {
                "groupId": "FG001",
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            ]
          }
        ]
      }
    ],
    "reviewUnit": {
      "resetReasons": [
        "Required information appears to be missing."
      ]
    }
  },
  "baselineCharacteristicsModule": {
    "denoms": [
      {
        "units": "Participants",
        "counts": [
          {
            "value": "6",
            "groupId": "BG000"
          },
          {
            "value": "0",
            "groupId": "BG001"
          },
          {
            "value": "6",
            "groupId": "BG002"
          }
        ]
      }
    ],
    "groups": [
      {
        "id": "BG000",
        "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": "BG001",
        "title": "Standard Neoadjuvant Chemotherapy",
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      },
      {
        "id": "BG002",
        "title": "Total",
        "description": "Total of all reporting groups"
      }
    ],
    "measures": [
      {
        "title": "Age, Categorical",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "6",
                    "groupId": "BG000"
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                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "&lt;=18 years",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Between 18 and 65 years",
                "measurements": [
                  {
                    "value": "5",
                    "groupId": "BG000"
                  },
                  {
                    "value": "5",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "&gt;=65 years",
                "measurements": [
                  {
                    "value": "1",
                    "groupId": "BG000"
                  },
                  {
                    "value": "1",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Age, Continuous",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "6",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "54",
                    "groupId": "BG000",
                    "lowerLimit": "26",
                    "upperLimit": "69"
                  },
                  {
                    "value": "54",
                    "groupId": "BG002",
                    "lowerLimit": "26",
                    "upperLimit": "69"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "MEAN",
        "unitOfMeasure": "years",
        "dispersionType": "FULL_RANGE"
      },
      {
        "title": "Sex: Female, Male",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "6",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  }
                ]
              }
            ],
            "categories": [
              {
                "title": "Female",
                "measurements": [
                  {
                    "value": "6",
                    "groupId": "BG000"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  }
                ]
              },
              {
                "title": "Male",
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants"
      },
      {
        "title": "Race and Ethnicity Not Collected",
        "classes": [
          {
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "0",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "0",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "COUNT_OF_PARTICIPANTS",
        "unitOfMeasure": "Participants",
        "populationDescription": "Race and Ethnicity were not collected from any participant."
      },
      {
        "title": "Region of Enrollment",
        "classes": [
          {
            "title": "France",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "6",
                    "groupId": "BG000"
                  },
                  {
                    "value": "0",
                    "groupId": "BG001"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  }
                ]
              }
            ],
            "categories": [
              {
                "measurements": [
                  {
                    "value": "6",
                    "groupId": "BG000"
                  },
                  {
                    "value": "6",
                    "groupId": "BG002"
                  }
                ]
              }
            ]
          }
        ],
        "paramType": "NUMBER",
        "unitOfMeasure": "participants"
      }
    ],
    "popReviewUnit": {
      "resetReasons": [
        "Required information appears to be missing."
      ]
    },
    "populationDescription": "only pembrolizumab patients have been analyzed for DLT"
  }
}
add /annotationSection
Triage: Uncategorized
Uncategorized Operation 23
After
{
  "annotationModule": {
    "unpostedAnnotation": {
      "unpostedEvents": [
        {
          "date": "2025-11-07",
          "type": "RESET"
        }
      ],
      "unpostedResponsibleParty": "Institut Paoli-Calmettes"
    }
  }
}
add /documentSection
Triage: Uncategorized
Uncategorized Operation 24
After
{
  "largeDocumentModule": {
    "largeDocs": [
      {
        "date": "2024-07-18",
        "size": 930776,
        "label": "Study Protocol and Statistical Analysis Plan",
        "hasIcf": false,
        "hasSap": true,
        "filename": "Prot_SAP_000.pdf",
        "typeAbbrev": "Prot_SAP",
        "uploadDate": "2025-10-21T06:09",
        "hasProtocol": true
      }
    ]
  }
}
Raw JSON Patch 
[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2025-10"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2025-10-24"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
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  },
  {
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  {
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  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "end of study"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit",
    "value": {
      "resetReasons": [
        "Required information appears to be missing."
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/1/measure",
    "value": "Dose Limiting Toxicity (DLT) Rates"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
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  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
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  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/measure",
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  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
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  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5/measure",
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  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/6/measure",
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  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
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  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/otherOutcomes/0/measure",
    "value": "Evaluation of PD-L1 Expression in Pre, Per and Post-treatment Tissue"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/otherOutcomes/1/measure",
    "value": "Measurement of Baseline Circulating Tumor Cells for Prospective Validation of Their Prognostic Value in IBC"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/otherOutcomes/2/measure",
    "value": "Disease Monitoring"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/otherOutcomes/3/measure",
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  {
    "op": "replace",
    "path": "/hasResults",
    "value": true
  },
  {
    "op": "add",
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        "certainAgreement": {
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        }
      },
      "adverseEventsModule": {
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        "reviewUnit": {
          "resetReasons": [
            "There does not appear to be sufficient information to understand the Time Frame."
          ]
        },
        "description": "This study only recorded AEs related to the investigational product, unlike ClinicalTrials.gov\nwhich includes all events.\nAEs were collected via active surveillance from all treated participants during the treatment period.",
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          {
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            "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>",
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            "deathsNumAtRisk": 6,
            "otherNumAffected": 6,
            "seriousNumAtRisk": 6,
            "deathsNumAffected": 0,
            "seriousNumAffected": 2
          },
          {
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            "deathsNumAtRisk": 0,
            "otherNumAffected": 0,
            "seriousNumAtRisk": 0,
            "deathsNumAffected": 0,
            "seriousNumAffected": 0
          }
        ],
        "otherEvents": [
          {
            "term": "ANEMIA",
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              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 4
              },
              {
                "groupId": "EG001",
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                "numAffected": 0
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "HYPERTHYROIDISM",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Endocrine disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "ASTHENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "MUCOSAL INFLAMMATION",
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              {
                "groupId": "EG000",
                "numAtRisk": 6,
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              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
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          },
          {
            "term": "GAMMA-GLUTAMYLTRANSFERASE INCREASED",
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              {
                "groupId": "EG000",
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                "numAffected": 3
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              {
                "groupId": "EG001",
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                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
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          },
          {
            "term": "NEUTROPHIL COUNT DECREASED",
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                "groupId": "EG000",
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              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
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          {
            "term": "WHITE BLOOD CELL COUNT DECREASED",
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                "groupId": "EG000",
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              {
                "groupId": "EG001",
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                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
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          {
            "term": "HEADACHE",
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              {
                "groupId": "EG000",
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                "numAffected": 1
              },
              {
                "groupId": "EG001",
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              }
            ],
            "organSystem": "Nervous system disorders",
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          {
            "term": "ALOPECIA",
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              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 3
              },
              {
                "groupId": "EG001",
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              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
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          {
            "term": "HYPERTENSION",
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              {
                "groupId": "EG000",
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                "numAffected": 1
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              {
                "groupId": "EG001",
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            ],
            "organSystem": "Vascular disorders",
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          },
          {
            "term": "CONSTIPATION",
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              {
                "groupId": "EG000",
                "numAtRisk": 6,
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                "groupId": "EG001",
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            "organSystem": "Vascular disorders",
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          },
          {
            "term": "NAUSEA",
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              {
                "groupId": "EG000",
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                "groupId": "EG001",
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            ],
            "organSystem": "Gastrointestinal disorders",
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          {
            "term": "FATIGUE",
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              {
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                "groupId": "EG001",
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            ],
            "organSystem": "General disorders",
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          },
          {
            "term": "URINARY TRACT INFECTION",
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              {
                "groupId": "EG000",
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              {
                "groupId": "EG001",
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            ],
            "organSystem": "Infections and infestations",
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          },
          {
            "term": "LYMPHOCYTE COUNT DECREASED",
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              {
                "groupId": "EG000",
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              {
                "groupId": "EG001",
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              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "GASTROINTESTINAL TOXICITY",
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              {
                "groupId": "EG000",
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              {
                "groupId": "EG001",
                "numAtRisk": 0,
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              }
            ],
            "organSystem": "Gastrointestinal disorders",
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          },
          {
            "term": "PYREXIA",
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              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "STOMATITIS",
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              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "DIARRHEA",
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              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "REFLUX GASTRITIS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "BLOOD ALKALINE PHOSPHATASE INCREASED",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "HAEMATOCRIT DECREASED",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "NEUTROPHIL COUNT INCREASED",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "RASH",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "PALPITATIONS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Cardiac disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "ABDOMINAL PAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "OEDEMA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "WEIGHT GAIN",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "WEIGHT LOSS",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "DECREASED APPETITE",
            "notes": "ANOREXIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "DYSGEUSIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "PERIPHERAL SENSORY NEUROPATHY",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Nervous system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "INSOMNIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 2
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Psychiatric disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "COUGH",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Respiratory, thoracic and mediastinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "ACNEA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "ERYTHEMA",
            "notes": "BREAST ERYTHEMA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "RASH MACULO-PAPULAR",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Skin and subcutaneous tissue disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "HOT FLUSH",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Vascular disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "FEBRILE NEUTROPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "LEUKOPENIA",
            "notes": "LEUCOPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "LYMPHOPENIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Blood and lymphatic system disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "BLOOD LACTATE DEHYDROGENASE INCREASED",
            "notes": "LACTATE DEHYDROGENASE INCREASED",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Investigations",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "HYPERKALAEMIA",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Metabolism and nutrition disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          }
        ],
        "seriousEvents": [
          {
            "term": "FEVER",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "General disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          },
          {
            "term": "VOMITING",
            "stats": [
              {
                "groupId": "EG000",
                "numAtRisk": 6,
                "numAffected": 1
              },
              {
                "groupId": "EG001",
                "numAtRisk": 0,
                "numAffected": 0
              }
            ],
            "organSystem": "Gastrointestinal disorders",
            "assessmentType": "SYSTEMATIC_ASSESSMENT"
          }
        ],
        "frequencyThreshold": "0"
      },
      "outcomeMeasuresModule": {
        "outcomeMeasures": [
          {
            "type": "PRIMARY",
            "title": "Central Evaluation of Pathological Complete Response Rate",
            "timeFrame": "end of study",
            "reviewUnit": {
              "resetReasons": [
                "Required information appears to be missing."
              ]
            },
            "description": "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)",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2027-08"
          },
          {
            "type": "PRIMARY",
            "title": "Dose Limiting Toxicity (DLT) Rates",
            "denoms": [
              {
                "units": "Participants",
                "counts": [
                  {
                    "value": "6",
                    "groupId": "OG000"
                  },
                  {
                    "value": "0",
                    "groupId": "OG001"
                  }
                ]
              }
            ],
            "groups": [
              {
                "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."
              ]
            }
          },
          {
            "type": "SECONDARY",
            "title": "Occurrence of Serious Adverse Events and Adverse Events Starting Grade 2 or Grade 1 (run-in Period)",
            "timeFrame": "during 21 days following the first administration of pembrolizumab",
            "description": "according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) V5.0",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants",
            "anticipatedPostingDate": "2027-08"
          },
          {
            "type": "SECONDARY",
            "title": "Local Evaluation of Pathological Complete Response Rate",
            "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
            "description": "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)",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "SECONDARY",
            "title": "Invasive Disease-free Survival (IDFS)",
            "timeFrame": "3 years",
            "description": "time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "SECONDARY",
            "title": "Invasive Disease-free Survival (IDFS)",
            "timeFrame": "5 years",
            "description": "time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence, Ipsilateral local-regional invasive breast cancer recurrence, Distant recurrence, Contralateral invasive breast cancer, Death from any cause",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "SECONDARY",
            "title": "Event Free Survival (EFS)",
            "timeFrame": "3 years",
            "description": "time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "SECONDARY",
            "title": "Event Free Survival (EFS)",
            "timeFrame": "5 years",
            "description": "time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non invasive]), or death from any cause)",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Survival (OS)",
            "timeFrame": "3 years",
            "description": "time from randomization to death from any cause",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "SECONDARY",
            "title": "Overall Survival (OS)",
            "timeFrame": "5 years",
            "description": "time from randomization to death from any cause",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "OTHER_PRE_SPECIFIED",
            "title": "Evaluation of PD-L1 Expression in Pre, Per and Post-treatment Tissue",
            "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
            "description": "by IHC and mass spectrometry-based proteomics; and in plasma samples using quantitative proteomics,",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "OTHER_PRE_SPECIFIED",
            "title": "Measurement of Baseline Circulating Tumor Cells for Prospective Validation of Their Prognostic Value in IBC",
            "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
            "description": "Measurement of baseline CTC for prospective validation of their prognostic value in IBC",
            "reportingStatus": "NOT_POSTED",
            "denomUnitsSelected": "Participants"
          },
          {
            "type": "OTHER_PRE_SPECIFIED",
            "title": "Disease Monitoring",
            "timeFrame": "Following completion of neoadjuvant systemic treatment, an average of 24 weeks",
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