{
    "info": {
        "nct_id": "NCT02278120",
        "official_title": "A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 59 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Key inclusion criteria:\n\n* Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy\n* Patients were premenopausal or perimenopausal at the time of study entry\n* Patients who had received (neo) adjuvant therapy for breast cancer were eligible\n* Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer\n* Patients had HER2-negative breast cancer\n* Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion\n* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Patients had adequate bone marrow and organ function\n\nKey exclusion criteria:\n\n* Patients who had received a prior CDK4/6 inhibitor\n* Patients were postmenopausal\n* Patients who currently had inflammatory breast cancer at screening.\n* Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.\n* Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.\n* Patients with CNS metastases.\n* Patients had active cardiac disease or a history of cardiac dysfunction\n* Patients were currently using other antineoplastic agents\n* Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception."
    },
    "inclusion_lines": [
        {
            "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 59 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 59 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 59,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy",
            "criterions": [
                {
                    "exact_snippets": "advanced (locoregionally recurrent or metastatic) breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "advanced",
                                "locoregionally recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to curative therapy",
                    "criterion": "curative therapy",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients were premenopausal or perimenopausal at the time of study entry",
            "criterions": [
                {
                    "exact_snippets": "Patients were premenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "premenopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "or perimenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "perimenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who had received (neo) adjuvant therapy for breast cancer were eligible",
            "criterions": [
                {
                    "exact_snippets": "Patients who had received (neo) adjuvant therapy for breast cancer",
                    "criterion": "(neo) adjuvant therapy for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "histologically and/or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "estrogen-receptor positive",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "progesterone receptor positive",
                    "criterion": "progesterone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients had HER2-negative breast cancer",
            "criterions": [
                {
                    "exact_snippets": "HER2-negative breast cancer",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion",
            "criterions": [
                {
                    "exact_snippets": "Patients must have either had measurable disease",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If no measurable disease was present, then at least one predominantly lytic bone lesion",
                    "criterion": "predominantly lytic bone lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients had adequate bone marrow and organ function",
            "criterions": [
                {
                    "exact_snippets": "adequate bone marrow",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who had received a prior CDK4/6 inhibitor",
            "criterions": [
                {
                    "exact_snippets": "Patients who had received a prior CDK4/6 inhibitor",
                    "criterion": "prior CDK4/6 inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients were postmenopausal",
            "criterions": [
                {
                    "exact_snippets": "postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who currently had inflammatory breast cancer at screening.",
            "criterions": [
                {
                    "exact_snippets": "inflammatory breast cancer at screening",
                    "criterion": "inflammatory breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer",
                    "criterion": "prior hormonal anti-cancer therapy for advanced breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization",
                    "criterion": "duration of tamoxifen or NSAI ± goserelin for advanced breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.",
            "criterions": [
                {
                    "exact_snippets": "concurrent malignancy",
                    "criterion": "concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "malignancy within 3 years of randomization",
                    "criterion": "malignancy within 3 years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated basal cell skin carcinoma",
                    "criterion": "adequately treated basal cell skin carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "squamous cell skin carcinoma",
                    "criterion": "squamous cell skin carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-melanomatous skin cancer",
                    "criterion": "non-melanomatous skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "curatively resected cervical cancer",
                    "criterion": "curatively resected cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with CNS metastases.",
            "criterions": [
                {
                    "exact_snippets": "Patients with CNS metastases",
                    "criterion": "CNS metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients had active cardiac disease or a history of cardiac dysfunction",
            "criterions": [
                {
                    "exact_snippets": "active cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of cardiac dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients were currently using other antineoplastic agents",
            "criterions": [
                {
                    "exact_snippets": "currently using other antineoplastic agents",
                    "criterion": "use of antineoplastic agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception.",
            "criterions": [
                {
                    "exact_snippets": "Patients were pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "nursing",
                    "criterion": "nursing status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "physiologically capable of becoming pregnant",
                    "criterion": "physiological capability of becoming pregnant",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "not using highly effective contraception",
                    "criterion": "use of highly effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Key inclusion criteria:",
            "criterions": []
        },
        {
            "line": "Key exclusion criteria:",
            "criterions": []
        }
    ]
}