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

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2018-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2018-12-13"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2018-12-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/description",
    "value": "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 infusion followed by gemcitabine 2000 mg/m2 as an i.v.\ninfusion.\nThe three drugs were administered every two weeks for 6 cycles."
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Drug: Gemcitabine"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1",
    "value": "Drug: Adriamycine"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/2",
    "value": "Drug: Paclitaxel"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Gemcitabine"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/0",
    "value": "Gemzar"
  },
  {
    "op": "remove",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/otherNames/1"
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/1",
    "value": {
      "name": "Adriamycine",
      "type": "DRUG",
      "otherNames": [
        "doxorubicin"
      ],
      "armGroupLabels": [
        "Gemcitabine + Adriamycine + Paclitaxel"
      ]
    }
  },
  {
    "op": "add",
    "path": "/protocolSection/armsInterventionsModule/interventions/2",
    "value": {
      "name": "Paclitaxel",
      "type": "DRUG",
      "otherNames": [
        "Taxol"
      ],
      "armGroupLabels": [
        "Gemcitabine + Adriamycine + Paclitaxel"
      ]
    }
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/measure",
    "value": "Pathological complete response (pCR) rate"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
    "value": "pCR is defined as no invasive cells identifiable in breast sections at surgery.\nResponse will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria.\nPathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "Up to week 15"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Overall response rate (ORR)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
    "value": "Tumor response is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
    "value": "Up to week 12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/description",
    "value": "To determine the percentage of conservative surgery rate versus other surgery"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
    "value": "Up to week 15"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/measure",
    "value": "The Number of Participants Who Experienced Adverse Events (AE)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
    "value": "According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
    "value": "Through study treatment up to surgery"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
    "value": "Up to 5 years since surgery"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/measure",
    "value": "Tissue molecular markers and their correlation with response"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
    "value": "Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment."
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
    "value": "Up to week 15"
  },
  {
    "op": "remove",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/5"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.</li><li>Ages between 18 and 75 years old.\nPatients older than 70 must have an adequate quality of life to be eligible.</li><li>Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.</li><li>Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).</li><li>At least a 6 month life expectancy.</li><li>Neutrophils &gt; 1500; platelets &gt; 100000; haemoglobin &gt; 10 mg&#x2F;dL.</li><li>Adequate renal and hepatic functions, with serum creatinine &lt; 1.2 mg&#x2F;dl and total bilirubin &lt; 2 mg&#x2F;dl.</li><li>Adequate contraceptive methods during the study and up to 3 months after.</li><li>Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction &gt; 55%.</li></ul><p>Exclusion Criteria:</p><ul><li>Inflammatory carcinoma or stage I, II or IV breast cancer disease.</li><li>Males.</li><li>Active infection.</li><li>Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated.\nOther previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.</li><li>Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).</li><li>Pre-existing motor or sensorial neuropathy &gt; grade 1.</li><li>Inability for treatment compliance.</li><li>History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.</li><li>History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.</li><li>History of myocardial infarction in the previous 6 months.</li><li>Hypertension not controlled.</li><li>Pregnant or lactating women.</li></ul>"
  },
  {
    "op": "replace",
    "path": "/protocolSection/referencesModule/seeAlsoLinks/0/label",
    "value": "Description Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group"
  }
]