{
    "info": {
        "nct_id": "NCT02783794",
        "official_title": "A Randomized, Double Blind and Placebo Controlled Multicenter Study Comparing BP-C1 and Equal Looking Placebo in Metastatic Breast Cancer Patients. A Phase IIB Study",
        "inclusion_criteria": "Female patients with histologically verified metastatic breast cancer (stage IV) with measurable metastases, between 18 and 80 years of age, who had undergone at least three lines of chemotherapy and had an expected survival time of at least 3 months.\n\nExclusion criteria:\n\nPatients fulfilling at least one of the following criteria will be excluded from participation in the study:\n\n* Abnormal liver function classified as total bilirubin >34 μmol/L or ALAT > 3 times of the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN.\n* Abnormal kidney function defined by serum creatinine >120 μmol/L.\n* Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10; INR >1.5.\n* Verified metastases to the brain.\n* Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.\n* Abnormal hematology status defined by hemoglobin < 9.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.\n* Clinically significant abnormal ECG.\n* Karnofsky performance status score <60%.\n* Pregnant or breast feeding women.\n* Women of fertile age who do not want to be tested for possible pregnancy.\n* Fertile female who do not want to use safe protection against pregnancy, starting one month before the start of the study treatment and lasting at least six weeks after.\n* Uncontrolled bacterial, viral, fungal or parasite infection.\n* Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment.\n* Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment.\n* Not able to understand information.\n* Not willing or not able to give written consent to participate in the study.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "Female patients with histologically verified metastatic breast cancer (stage IV) with measurable metastases, between 18 and 80 years of age, who had undergone at least three lines of chemotherapy and had an expected survival time of at least 3 months.",
            "criterions": [
                {
                    "exact_snippets": "Female patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically verified metastatic breast cancer (stage IV)",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IV"
                        },
                        {
                            "requirement_type": "verification",
                            "expected_value": "histologically verified"
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable metastases",
                    "criterion": "metastases",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "between 18 and 80 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 80,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "undergone at least three lines of chemotherapy",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "lines",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "expected survival time of at least 3 months",
                    "criterion": "expected survival time",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal liver function classified as total bilirubin >34 μmol/L or ALAT > 3 times of the upper limit of normal (ULN). In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN.",
            "criterions": [
                {
                    "exact_snippets": "Abnormal liver function classified as total bilirubin >34 μmol/L",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 34,
                                "unit": "μmol/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal liver function classified as ... ALAT > 3 times of the upper limit of normal (ULN)",
                    "criterion": "ALAT",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "In case of metastases in the liver, the ALAT limit for exclusion is set to 5хULN",
                    "criterion": "ALAT with liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal kidney function defined by serum creatinine >120 μmol/L.",
            "criterions": [
                {
                    "exact_snippets": "Abnormal kidney function defined by serum creatinine >120 μmol/L.",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 120,
                                "unit": "μmol/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10; INR >1.5.",
            "criterions": [
                {
                    "exact_snippets": "Abnormal coagulation capacity defined by the relative arbitrary concentration of coagulation factors 2,7,10",
                    "criterion": "coagulation factors 2,7,10",
                    "requirements": [
                        {
                            "requirement_type": "concentration",
                            "expected_value": "abnormal"
                        }
                    ]
                },
                {
                    "exact_snippets": "INR >1.5",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Verified metastases to the brain.",
            "criterions": [
                {
                    "exact_snippets": "Verified metastases to the brain",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "verification",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Synchronous cancer except for non-melanoma skin cancer and early stage of cervical cancer.",
            "criterions": [
                {
                    "exact_snippets": "Synchronous cancer",
                    "criterion": "synchronous cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "early stage of cervical cancer",
                    "criterion": "early stage cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Abnormal hematology status defined by hemoglobin < 9.0 g/dL, platelet count < 100,000/mm^3 or leucocytes < 3 x 10^9/L.",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin < 9.0 g/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count < 100,000/mm^3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": "<",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "leucocytes < 3 x 10^9/L",
                    "criterion": "leucocyte count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "x 10^9/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant abnormal ECG.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant abnormal ECG",
                    "criterion": "ECG",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status score <60%.",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status score <60%",
                    "criterion": "Karnofsky performance status score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or breast feeding women.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast feeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of fertile age who do not want to be tested for possible pregnancy.",
            "criterions": [
                {
                    "exact_snippets": "Women of fertile age",
                    "criterion": "fertile age",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "do not want to be tested for possible pregnancy",
                    "criterion": "willingness to be tested for pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile female who do not want to use safe protection against pregnancy, starting one month before the start of the study treatment and lasting at least six weeks after.",
            "criterions": [
                {
                    "exact_snippets": "Fertile female",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "fertility status",
                            "expected_value": "fertile"
                        }
                    ]
                },
                {
                    "exact_snippets": "do not want to use safe protection against pregnancy",
                    "criterion": "use of contraception",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "starting one month before the start of the study treatment and lasting at least six weeks after",
                    "criterion": "duration of contraception use",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "one month before the start of the study treatment and lasting at least six weeks after"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled bacterial, viral, fungal or parasite infection.",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled bacterial ... infection.",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... viral ... infection.",
                    "criterion": "viral infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... fungal ... infection.",
                    "criterion": "fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... parasite infection.",
                    "criterion": "parasite infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Under systemic treatment with corticosteroids or other immunosuppressive drugs in the last 21 days before start of the trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Under systemic treatment with corticosteroids",
                    "criterion": "systemic treatment with corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "other immunosuppressive drugs",
                    "criterion": "systemic treatment with other immunosuppressive drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the last 21 days before start of the trial treatment",
                    "criterion": "time since last systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Participating in another clinical trial with pharmaceuticals in the last six weeks before start of this trial treatment.",
                    "criterion": "participation in another clinical trial with pharmaceuticals",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 6,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not able to understand information.",
            "criterions": [
                {
                    "exact_snippets": "Not able to understand information.",
                    "criterion": "ability to understand information",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Not willing or not able to give written consent to participate in the study.",
            "criterions": [
                {
                    "exact_snippets": "Not willing ... to give written consent",
                    "criterion": "willingness to give written consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not able to give written consent",
                    "criterion": "ability to give written consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Exclusion criteria:",
            "criterions": []
        },
        {
            "line": "Patients fulfilling at least one of the following criteria will be excluded from participation in the study:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}