Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients

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    "path": "/protocolSection/identificationModule/officialTitle",
    "value": "Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2018-03"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2003-03"
  },
  {
    "op": "add",
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    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2015-01"
  },
  {
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    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-03-15"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-03-19"
  },
  {
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      "type": "ACTUAL"
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    "value": {
      "type": "SPONSOR"
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  {
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    "path": "/protocolSection/designModule/designInfo/allocation",
    "value": "NA"
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  {
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    "value": 46
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  },
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    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/armGroupLabels",
    "value": [
      "Gemcitabine + Adriamycine + Paclitaxel"
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames",
    "value": [
      "doxorubicin",
      "Paclitaxel"
    ]
  },
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    "path": "/protocolSection/armsInterventionsModule/interventions/1"
  },
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      {
        "type": "EXPERIMENTAL",
        "label": "Gemcitabine + Adriamycine + Paclitaxel",
        "description": "Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v.\ninfusion.\nPaclitaxel 150 mg/m2 was administered on day 2 as an i.v infusión followed by gemcitabine 2000 mg/m2 as an i.v.\ninfusion.\nThe three drugs were administered every two weeks for 6 cycles.",
        "interventionNames": [
          "Drug: gemcitabine"
        ]
      }
    ]
  },
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    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "To determine the pathological response after surgery, based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axila lymph nodes."
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    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "up to 5 months from last patient included"
  },
  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "It is evaluated by measuring the target lesions before and after treatment."
  },
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    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "up to 3 months from last patient included"
  },
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    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "Conservative surgery rate versus other sugery"
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  {
    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "up to 5 months from last patient included"
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    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "According to the criteria CTC version 2.0"
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    "value": "up to 6 months from last patient included"
  },
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    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/description",
    "value": "Time from the start of treatment to the progression of the disease (if it happens)"
  },
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    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "5 years since surgery of last patient included"
  },
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    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "value": "Evaluation of changes in the tumor marker profile before and after treatment"
  },
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    "op": "add",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "3 years"
  },
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    "op": "add",
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  },
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    "path": "/protocolSection/contactsLocationsModule/locations/0/city",
    "value": "Badalona"
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