{
    "info": {
        "nct_id": "NCT03355157",
        "official_title": "A Randomized, Open-label, Multi-center Phase IV Study Evaluating Palbociclib Plus Endocrine Treatment Versus a Chemotherapy-based Treatment Strategy in Patients With Hormone Receptor Positive / HER2 Negative Breast Cancer in a Real World Setting (GBG 93 - PADMA Study).",
        "inclusion_criteria": "1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, willingness and ability to complete collection of data via wearable device and study mobile must be obtained and documented according to the local regulatory requirements.\n2. Female or male patients.\n3. Age ≥ 18 years old.\n4. Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed).\n5. Patients who in the opinion of the treating physician are candidates suitable for randomization for mono-chemotherapy treatment, that has either an approved label in Europe and/or is supported by guidelines for the treatment of first-line advanced BC, which are based on evidence on safety and efficacy in this setting.\n6. Symptomatic or asymptomatic metastatic breast cancer.\n7. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n8. Life-expectancy > 6 months.\n9. For female patients: The patients need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) B) childbearing potential with negative serum or urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive methods).\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab.\n2. Asymptomatic oligometastases of the bone as the only site of metastatic disease.\n3. Uncontrolled/untreated central nervous system lesions.\n4. Patients who received treatment for metastatic/relapsed breast cancer.\n5. Inadequate organ function as per physician's assessment immediate prior to randomization.\n6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use.\n7. Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy.\n8. Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy.\n9. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption.\n10. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to six months after treatment. Male patients: Intention to beget a child during the study and up to six months after treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, willingness and ability to complete collection of data via wearable device and study mobile must be obtained and documented according to the local regulatory requirements.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Written informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "documentation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "expected cooperation of the patients for the treatment and follow-up"
                    ],
                    "criterion": "patient cooperation",
                    "requirement_type": "expectation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "willingness and ability to complete collection of data via wearable device and study mobile"
                    ],
                    "criterion": "data collection",
                    "requirement_type": "willingness and ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Female or male patients.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female or male patients"
                    ],
                    "criterion": "gender",
                    "requirement_type": "allowed values",
                    "expected_value": [
                        "female",
                        "male"
                    ]
                }
            ]
        },
        {
            "line": "3. Age ≥ 18 years old.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥ 18 years old"
                    ],
                    "criterion": "age",
                    "requirement_type": "N/A",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "4. Metastatic invasive hormone receptor positive and HER2 negative breast cancer (histologically confirmed).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Metastatic invasive hormone receptor positive"
                    ],
                    "criterion": "hormone receptor",
                    "requirement_type": "status",
                    "expected_value": "positive"
                },
                {
                    "exact_snippets": [
                        "HER2 negative"
                    ],
                    "criterion": "HER2",
                    "requirement_type": "status",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "breast cancer"
                    ],
                    "criterion": "breast cancer",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Metastatic"
                    ],
                    "criterion": "metastasis",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "histologically confirmed"
                    ],
                    "criterion": "histological confirmation",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. Patients who in the opinion of the treating physician are candidates suitable for randomization for mono-chemotherapy treatment, that has either an approved label in Europe and/or is supported by guidelines for the treatment of first-line advanced BC, which are based on evidence on safety and efficacy in this setting.",
            "criterions": [
                {
                    "exact_snippets": [
                        "opinion of the treating physician",
                        "candidates suitable for randomization"
                    ],
                    "criterion": "suitability for randomization",
                    "requirement_type": "opinion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "mono-chemotherapy treatment",
                        "approved label in Europe"
                    ],
                    "criterion": "mono-chemotherapy treatment",
                    "requirement_type": "approval status",
                    "expected_value": "approved in Europe"
                },
                {
                    "exact_snippets": [
                        "mono-chemotherapy treatment",
                        "supported by guidelines"
                    ],
                    "criterion": "mono-chemotherapy treatment",
                    "requirement_type": "guideline support",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "treatment of first-line advanced BC"
                    ],
                    "criterion": "treatment setting",
                    "requirement_type": "specificity",
                    "expected_value": "first-line advanced BC"
                },
                {
                    "exact_snippets": [
                        "evidence on safety and efficacy"
                    ],
                    "criterion": "evidence",
                    "requirement_type": "safety and efficacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "6. Symptomatic or asymptomatic metastatic breast cancer.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Symptomatic or asymptomatic metastatic breast cancer"
                    ],
                    "criterion": "metastatic breast cancer",
                    "requirement_type": "symptom presence",
                    "expected_value": [
                        "symptomatic",
                        "asymptomatic"
                    ]
                }
            ]
        },
        {
            "line": "7. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures"
                    ],
                    "criterion": "acute toxic effects",
                    "requirement_type": "resolution",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "NCI CTCAE version 4.0 grade ≤ 1"
                    ],
                    "criterion": "NCI CTCAE grade",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion"
                    ],
                    "criterion": "alopecia",
                    "requirement_type": "safety risk",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion"
                    ],
                    "criterion": "other toxicities",
                    "requirement_type": "safety risk",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "8. Life-expectancy > 6 months.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life-expectancy > 6 months"
                    ],
                    "criterion": "life-expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">",
                        "value": 6
                    }
                }
            ]
        },
        {
            "line": "9. For female patients: The patients need to be either A) of non-childbearing potential (documented postmenopausal or post hysterectomy) B) childbearing potential with negative serum or urinary pregnancy test (in this case patients need to use highly effective non-hormonal contraceptive methods).",
            "criterions": [
                {
                    "exact_snippets": [
                        "female patients"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "non-childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "documented postmenopausal"
                    ],
                    "criterion": "menopausal status",
                    "requirement_type": "documentation",
                    "expected_value": "postmenopausal"
                },
                {
                    "exact_snippets": [
                        "post hysterectomy"
                    ],
                    "criterion": "surgical history",
                    "requirement_type": "procedure",
                    "expected_value": "hysterectomy"
                },
                {
                    "exact_snippets": [
                        "childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "negative serum or urinary pregnancy test"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "use highly effective non-hormonal contraceptive methods"
                    ],
                    "criterion": "contraceptive methods",
                    "requirement_type": "type",
                    "expected_value": "highly effective non-hormonal"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "2. Asymptomatic oligometastases of the bone as the only site of metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Asymptomatic oligometastases"
                    ],
                    "criterion": "oligometastases",
                    "requirement_type": "symptoms",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "oligometastases of the bone"
                    ],
                    "criterion": "oligometastases",
                    "requirement_type": "location",
                    "expected_value": "bone"
                },
                {
                    "exact_snippets": [
                        "only site of metastatic disease"
                    ],
                    "criterion": "metastatic disease",
                    "requirement_type": "location",
                    "expected_value": "bone"
                }
            ]
        },
        {
            "line": "3. Uncontrolled/untreated central nervous system lesions.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Uncontrolled",
                        "central nervous system lesions"
                    ],
                    "criterion": "central nervous system lesions",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "untreated",
                        "central nervous system lesions"
                    ],
                    "criterion": "central nervous system lesions",
                    "requirement_type": "treatment",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "4. Patients who received treatment for metastatic/relapsed breast cancer.",
            "criterions": [
                {
                    "exact_snippets": [
                        "treatment for metastatic/relapsed breast cancer"
                    ],
                    "criterion": "treatment",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "metastatic/relapsed breast cancer"
                    ],
                    "criterion": "breast cancer",
                    "requirement_type": "stage",
                    "expected_value": [
                        "metastatic",
                        "relapsed"
                    ]
                }
            ]
        },
        {
            "line": "5. Inadequate organ function as per physician's assessment immediate prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Inadequate organ function"
                    ],
                    "criterion": "organ function",
                    "requirement_type": "adequacy",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "6. Treatment with preparations containing St. John´s Wort within the last 7 days prior to randomization and/or concurrent use.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Treatment with preparations containing St. John´s Wort"
                    ],
                    "criterion": "St. John´s Wort",
                    "requirement_type": "treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within the last 7 days prior to randomization"
                    ],
                    "criterion": "St. John´s Wort treatment",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 7
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "concurrent use"
                    ],
                    "criterion": "St. John´s Wort",
                    "requirement_type": "concurrent use",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "7. Known severe hypersensitivity reactions to compounds or excipients similar to palbociclib, planned chemotherapy or planned endocrine therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known severe hypersensitivity reactions",
                        "compounds or excipients similar to palbociclib"
                    ],
                    "criterion": "hypersensitivity reactions",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "Known severe hypersensitivity reactions",
                        "planned chemotherapy"
                    ],
                    "criterion": "hypersensitivity reactions",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                },
                {
                    "exact_snippets": [
                        "Known severe hypersensitivity reactions",
                        "planned endocrine therapy"
                    ],
                    "criterion": "hypersensitivity reactions",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            ]
        },
        {
            "line": "8. Existing contraindication against the use of palbociclib, planned chemotherapy or planned endocrine therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Existing contraindication against the use of palbociclib"
                    ],
                    "criterion": "palbociclib",
                    "requirement_type": "contraindication",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "planned chemotherapy"
                    ],
                    "criterion": "chemotherapy",
                    "requirement_type": "planned",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "planned endocrine therapy"
                    ],
                    "criterion": "endocrine therapy",
                    "requirement_type": "planned",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "9. Patients with hereditary problems of galactose intolerance, the Lapp lactase deficiency, and glucose-galactose malabsorption.",
            "criterions": [
                {
                    "exact_snippets": [
                        "hereditary problems of galactose intolerance"
                    ],
                    "criterion": "galactose intolerance",
                    "requirement_type": "hereditary problems",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Lapp lactase deficiency"
                    ],
                    "criterion": "Lapp lactase deficiency",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "glucose-galactose malabsorption"
                    ],
                    "criterion": "glucose-galactose malabsorption",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "1. Indication for poly-chemotherapy or single-agent endocrine therapy only or bevacizumab.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Indication for poly-chemotherapy"
                    ],
                    "criterion": "poly-chemotherapy",
                    "requirement_type": "indication",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Indication for single-agent endocrine therapy"
                    ],
                    "criterion": "single-agent endocrine therapy",
                    "requirement_type": "indication",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Indication for bevacizumab"
                    ],
                    "criterion": "bevacizumab",
                    "requirement_type": "indication",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "10. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and up to six months after treatment. Male patients: Intention to beget a child during the study and up to six months after treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female patients: pregnancy"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Female patients: lactation"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Female patients:",
                        "intention to become pregnant during the study and up to six months after treatment"
                    ],
                    "criterion": "intention to become pregnant",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Male patients:",
                        "Intention to beget a child during the study and up to six months after treatment"
                    ],
                    "criterion": "intention to beget a child",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}