{
  "FullStudy":{
    "Rank":217828,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516307",
          "OrgStudyIdInfo":{
            "OrgStudyId":"OPT-822-001"
          },
          "Organization":{
            "OrgFullName":"OBI Pharma, Inc",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Metastatic Breast Cancer Subjects",
          "OfficialTitle":"A Double-blind, Randomized Trial of Active Immunotherapy With Globo H-KLH (OPT-822) in Subjects With Metastatic Breast Cancer"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2016",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2019",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "DispFirstSubmitDate":"March 2, 2017",
          "DispFirstSubmitQCDate":"March 2, 2017",
          "DispFirstPostDateStruct":{
            "DispFirstPostDate":"March 3, 2017",
            "DispFirstPostDateType":"Actual"
          },
          "LastUpdateSubmitDate":"September 23, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 4, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"OBI Pharma, Inc",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes",
          "IsFDARegulatedDrug":"Yes",
          "IsFDARegulatedDevice":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to compare active immunotherapy (OPT-822/OPT-821) with PBS in combination with low dose cyclophosphamide, in post-treated metastatic breast cancer subjects with stable disease or response to treatment."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Metastatic Breast Cancer"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"349",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Patients will be randomized 2:1 to receive OPT-822/OPT-821(30 μg/100 μg) plus Cyclophosphamide IV (300mg/m2).",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: OPT-822/OPT-821(30 μg/100 μg)",
                    "Drug: Cyclophosphamide"
                  ]
                }
              },{
                "ArmGroupLabel":"Phosphate Buffer Saline (PBS) and Cyclophosphamide",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Patients will receive Phosphate Buffer Saline (PBS) plus Cyclophosphamide IV (300mg/m2).",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Phosphate Buffer Saline (PBS)",
                    "Drug: Cyclophosphamide"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"OPT-822/OPT-821(30 μg/100 μg)",
                "InterventionDescription":"Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide"
                  ]
                }
              },{
                "InterventionType":"Biological",
                "InterventionName":"Phosphate Buffer Saline (PBS)",
                "InterventionDescription":"Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Phosphate Buffer Saline (PBS) and Cyclophosphamide"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Cyclophosphamide",
                "InterventionDescription":"Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "OPT-822/OPT-821 (30 μg/100 μg) and Cyclophosphamide",
                    "Phosphate Buffer Saline (PBS) and Cyclophosphamide"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Progression Free Survival (PFS)",
                "PrimaryOutcomeTimeFrame":"Progression or up to 2 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Overall Survival (OS)",
                "SecondaryOutcomeTimeFrame":"5 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFemale subjects ≥ 21 years of age with histological or cytological diagnosis of breast carcinoma.\nSubjects with metastatic breast cancer who have achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy (i.e. chemotherapy or target therapy, either alone or in any combination). Involvement of supraclavicular lymph node is considered metastasis.\nSubjects must have recovered from toxicities of prior therapies. (i.e. CTCAE ≤ grade 2).\nPerformance status: ECOG ≤ 1 and life expectancy ≥ 3 months.\n\nOrgan Function Requirements - Subjects must have adequate organ functions as defined below:\n\nAST/ALT ≤ 3X ULN (upper limit of normal)\nAST/ALT ≤ 5X ULN [with underlying Liver Metastasis]\nTotal Bilirubin ≤ 2.0 X ULN\nSerum Creatinine ≤ 1.5X ULN\nANC ≥ 1500 /μL\nPlatelets > 100,000/μL\nNo Symptomatic Congestive Heart Failure (Ejection Fraction EF ≥ 50%)\nAbility to understand and the willingness to sign a written informed consent document according to institutional guidelines.\nAll positive or negative ER (estrogen receptor), PR (progesterone receptor), and HER-2 subjects are eligible for this study.\nHowever, subjects who are HER-2 positive and responsive to anti-HER-2 therapy (e.g. Herceptin), are encouraged to remain on anti-HER-2 therapy and not enroll in this trial.\nSubjects who desire to enroll in this study and for whom anti-HER-2 therapy is not available or contraindicated, may be eligible to enroll in this trial.\nIn countries where continuous anti-HER2 therapy is considered standard of care for HER-2 positive metastatic disease, HER-2 positive subjects are not eligible.\nWomen of childbearing potential must be willing to implement adequate contraception during the study. An adequate method of contraception will be at the investigator's discretion.\n\nExclusion Criteria:\n\nSubjects are pregnant or breast-feeding at entry.\nSubjects with more than 2 events of disease progression after the development of metastatic breast cancer.\n\nSubjects who are currently receiving any other concomitant anticancer therapy with the EXCEPTION of bisphosphonates and hormone therapy.\n\nDuring the study period, subjects using hormonal therapy and bisphosphonates should maintain a constant dose and should not change existing regimen.\nHowever, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.\nSubjects with metastasis limited to the bone only are excluded. However, subjects with current metastasis limited to the bone only and with a history of distant metastasis are eligible. Subjects with current metastasis limited to the bone only and with current breast tissue lesion are eligible.\nSubjects who have any history of other malignancy (except non-melanoma skin carcinoma and carcinoma-in-situ of the uterine cervix) within 5 years of study entry.\nSubjects with splenectomy.\nSubjects with HIV infection.\n\nSubjects with any major autoimmune diseases or autoimmune disorders requiring systemic iv/oral steroids or immunosuppressive or immunomodulatory therapies.\n\ne.g. Type 1 juvenile onset diabetes mellitus, antibody positive for rheumatoid arthritis, Grave's disease, Hashimoto's thyroiditis, lupus, scleroderma, systemic vasculitis, hemolytic anemia, immune mediated thrombocytopenia, etc\nAutoimmune disorders confined to the skin (e.g. psoriasis) are eligible, and topical steroids are allowed for the treatment of such skin disorders.\nSubjects with any known uncontrolled inter-current illness including ongoing or active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n\nSubjects with any of the following MEDICATIONS within 4 weeks prior to randomization:\n\nAnti-neoplastic agents\nImmunotherapy [mAbs, Interferons, Cytokines (except GCSF)]\nImmunosuppressants (e.g. Cyclosporin, Rapamycin, Tacrolimus, Rituximab, Alemtuzumab, Natalizumab, etc.).\nAnother investigational drug\nSubjects with pleural effusions and/or ascites, due to malignancy, requiring paracentesis every 2 weeks or more frequently.\nSubjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.\nSubjects with bladder inflammation and urinary outflow obstruction.",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"21 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"The University of Alabama at Birmingham (UAB)",
                "LocationCity":"Birmingham",
                "LocationState":"Alabama",
                "LocationZip":"35294",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"St. Jude Heritage Healthcare, Virginia K. Crosson Cancer Center",
                "LocationCity":"Fullerton",
                "LocationState":"California",
                "LocationZip":"92835",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of California, San Diego (UCSD)",
                "LocationCity":"La Jolla",
                "LocationState":"California",
                "LocationZip":"92093",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of California, Irvine (UCI)",
                "LocationCity":"Orange",
                "LocationState":"California",
                "LocationZip":"92868",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of California, San Francisco (UCSF)",
                "LocationCity":"San Francisco",
                "LocationState":"California",
                "LocationZip":"94115",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Coastal Integrative Cancer Care",
                "LocationCity":"San Luis Obispo",
                "LocationState":"California",
                "LocationZip":"93401",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Central Coast Medical Oncology Corporation",
                "LocationCity":"Santa Maria",
                "LocationState":"California",
                "LocationZip":"93454",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of California, Los Angeles (UCLA)",
                "LocationCity":"Santa Monica",
                "LocationState":"California",
                "LocationZip":"90404",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Memorial Regional Hospital",
                "LocationCity":"Hollywood",
                "LocationState":"Florida",
                "LocationZip":"33021",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of Chicago Medical Center",
                "LocationCity":"Chicago",
                "LocationState":"Illinois",
                "LocationZip":"60637",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Weill Cornell Medical College",
                "LocationCity":"New York",
                "LocationState":"New York",
                "LocationZip":"10065",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Hope Women's Cancer Center",
                "LocationCity":"Asheville",
                "LocationState":"North Carolina",
                "LocationZip":"28801",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"University of Texas MD Anderson Cancer Center",
                "LocationCity":"Houston",
                "LocationState":"Texas",
                "LocationZip":"77030",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"UNIMED Medical Institute",
                "LocationCity":"Hong-Kong",
                "LocationCountry":"China"
              },{
                "LocationFacility":"HCG, Bangalore Institute of Oncology",
                "LocationCity":"Bengaluru",
                "LocationCountry":"India"
              },{
                "LocationFacility":"Curie Manavata Cancer Centre",
                "LocationCity":"Mumbai",
                "LocationCountry":"India"
              },{
                "LocationFacility":"Pusan National University Hospital",
                "LocationCity":"Busan-si",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Dong-A University Hospital",
                "LocationCity":"Busan",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Inha University Hospital",
                "LocationCity":"Chungcheongbuk-Do",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"National Cancer Center",
                "LocationCity":"Chungcheongbuk-Do",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Kyungpook National University Medical Center",
                "LocationCity":"Daegu",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Yeungnam University Medical Center",
                "LocationCity":"Daegu",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Asan Medical Center",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Korea University Anam Hospital",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Seoul National University Hospital ,",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Seoul St. Mary's Hospital",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Severance Hospital",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Changhua Christian Hospital",
                "LocationCity":"Changhua County",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Kaohsiung Medical University Hospital",
                "LocationCity":"Kaohsiung City",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Kaohsiung Veterans General Hospital",
                "LocationCity":"Kaohsiung City",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Chang Gung Memorial Hospital-KS",
                "LocationCity":"Kaohsiung",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Chang Gung Memorial Hospital -Linkou",
                "LocationCity":"Linkou",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Mackay Memorial Hospital",
                "LocationCity":"New Taipei City",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"China Medical University Hospital",
                "LocationCity":"Taichung",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Taichung Veterans General Hospital",
                "LocationCity":"Taichung",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Chi Mei Medical Center",
                "LocationCity":"Tainan City",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"National Cheng Kung University Hospital",
                "LocationCity":"Tainan",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Koo Foundation Sun Yat-Sen Cancer Center",
                "LocationCity":"Taipei City",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Taipei Veterans General Hospital",
                "LocationCity":"Taipei City",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Chang Gung Memorial Hospital-Taipei",
                "LocationCity":"Taipei",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"National Taiwan University Hospital",
                "LocationCity":"Taipei",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Shuang-Ho Hospital",
                "LocationCity":"Taipei",
                "LocationCountry":"Taiwan"
              },{
                "LocationFacility":"Tri-Service General Hospital",
                "LocationCity":"Taipei",
                "LocationCountry":"Taiwan"
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"No"
        }
      },
      "ResultsSection":{
        "MoreInfoModule":{}
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000003520",
                "InterventionMeshTerm":"Cyclophosphamide"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000007166",
                "InterventionAncestorTerm":"Immunosuppressive Agents"
              },{
                "InterventionAncestorId":"D000007155",
                "InterventionAncestorTerm":"Immunologic Factors"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000018501",
                "InterventionAncestorTerm":"Antirheumatic Agents"
              },{
                "InterventionAncestorId":"D000018906",
                "InterventionAncestorTerm":"Antineoplastic Agents, Alkylating"
              },{
                "InterventionAncestorId":"D000000477",
                "InterventionAncestorTerm":"Alkylating Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000000970",
                "InterventionAncestorTerm":"Antineoplastic Agents"
              },{
                "InterventionAncestorId":"D000019653",
                "InterventionAncestorTerm":"Myeloablative Agonists"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M5310",
                "InterventionBrowseLeafName":"Cyclophosphamide",
                "InterventionBrowseLeafAsFound":"Cyclophosphamide",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8795",
                "InterventionBrowseLeafName":"Immunosuppressive Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8784",
                "InterventionBrowseLeafName":"Immunologic Factors",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19188",
                "InterventionBrowseLeafName":"Antirheumatic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2401",
                "InterventionBrowseLeafName":"Alkylating Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"ANeo",
                "InterventionBrowseBranchName":"Antineoplastic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"ARhu",
                "InterventionBrowseBranchName":"Antirheumatic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001943",
                "ConditionMeshTerm":"Breast Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000001941",
                "ConditionAncestorTerm":"Breast Diseases"
              },{
                "ConditionAncestorId":"D000012871",
                "ConditionAncestorTerm":"Skin Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3802",
                "ConditionBrowseLeafName":"Breast Neoplasms",
                "ConditionBrowseLeafAsFound":"Breast Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3800",
                "ConditionBrowseLeafName":"Breast Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M14257",
                "ConditionBrowseLeafName":"Skin Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}