Vaccination of High Risk Breast Cancer Patients

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2021-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "RECRUITING"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2015-01-14"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2021-04-02"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2021-04-06"
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer."
  },
  {
    "op": "add",
    "path": "/protocolSection/descriptionModule/detailedDescription",
    "value": "<p>The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients with clinical stage I, II or III estrogen-receptor (ER)-positive, HER2-negative breast cancer.</p><p>This is a single-arm, multi-site Phase I&#x2F;II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive, HER2-negativebreast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials.\nP10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive, HER2-negative breast cancer.</p>"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/conditions/0",
    "value": "Breast Cancer"
  },
  {
    "op": "add",
    "path": "/protocolSection/conditionsModule/keywords",
    "value": [
      "clinical stage I, II or III",
      "ER postive",
      "HER2 negative"
    ]
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0",
    "value": "Biological: Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/1/interventionNames/0",
    "value": "Biological: Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/2/interventionNames/0",
    "value": "Biological: Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/3/interventionNames/0",
    "value": "Biological: Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/4/interventionNames/0",
    "value": "Biological: Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/5/interventionNames/0",
    "value": "Biological: Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/armGroups/6/interventionNames/0",
    "value": "Biological: Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/armsInterventionsModule/interventions/0/name",
    "value": "Chemovax - P10s-PADRE&#x2F; MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
    "value": "At the time of definitive surgery (4-8 weeks after chemo, which is between Week 22 and Week 25)"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status",
    "value": "ACTIVE_NOT_RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1/status",
    "value": "RECRUITING"
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/locations/1/contacts",
    "value": [
      {
        "name": "Issam Makhoul, MD",
        "role": "CONTACT",
        "email": "MakhoulIssam@uams.edu",
        "phone": "501-526-6990"
      },
      {
        "name": "Beth Scanlan, MAP",
        "role": "CONTACT",
        "email": "bscanlan@uams.edu",
        "phone": "5016868274"
      },
      {
        "name": "Issam Makhoul, MD",
        "role": "PRINCIPAL_INVESTIGATOR"
      }
    ]
  },
  {
    "op": "add",
    "path": "/protocolSection/contactsLocationsModule/centralContacts",
    "value": [
      {
        "name": "Issam Makhoul, MD",
        "role": "CONTACT",
        "email": "MakhoulIssam@uams.edu",
        "phone": "5015266990"
      },
      {
        "name": "Beth Scanlan, MAP",
        "role": "CONTACT",
        "email": "bscanlan@uams.edu",
        "phone": "5016868274"
      }
    ]
  }
]