{
    "info": {
        "nct_id": "NCT03703466",
        "official_title": "An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer",
        "inclusion_criteria": "* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).\n* Have all of the following:\n\n  * Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.\n  * Prior treatment with chemotherapy for locally advanced or metastatic disease.\n  * No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.\n* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.\n* Have adequate organ function.\n* Women of child-bearing potential must have a negative pregnancy test.\n* Are able to swallow tablets/capsules.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Are currently receiving treatment in a clinical study involving an investigational product.\n* Have a serious concomitant systemic disorder.\n* Have symptomatic central nervous system (CNS) malignancy or metastasis.\n* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.\n* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n* Have a history of any other cancer.\n* Had major surgery within 14 days prior to randomization.\n* Are breastfeeding.\n* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of HR+",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "HR+"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2-",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "HER2-"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic breast cancer (mBC)",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have all of the following:",
            "criterions": [
                {
                    "exact_snippets": "all of the following",
                    "criterion": "all of the following",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.",
            "criterions": [
                {
                    "exact_snippets": "Recurrent",
                    "criterion": "cancer recurrence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "surgical resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "mBC",
                    "criterion": "metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease progression following anti-estrogen therapy",
                    "criterion": "disease progression after anti-estrogen therapy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with chemotherapy for locally advanced or metastatic disease.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with chemotherapy for locally advanced or metastatic disease.",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.",
                    "criterion": "prior treatment with CDK 4 and 6 inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.",
            "criterions": [
                {
                    "exact_snippets": "discontinued all previous treatments for cancer",
                    "criterion": "previous cancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "recovered from the acute effects of therapy",
                    "criterion": "recovery from acute effects of therapy",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have adequate organ function.",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women of child-bearing potential must have a negative pregnancy test.",
            "criterions": [
                {
                    "exact_snippets": "Women of child-bearing potential",
                    "criterion": "child-bearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are able to swallow tablets/capsules.",
            "criterions": [
                {
                    "exact_snippets": "able to swallow tablets/capsules",
                    "criterion": "ability to swallow tablets/capsules",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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 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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Are currently receiving treatment in a clinical study involving an investigational product.",
            "criterions": [
                {
                    "exact_snippets": "currently receiving treatment in a clinical study involving an investigational product",
                    "criterion": "treatment in a clinical study",
                    "requirements": [
                        {
                            "requirement_type": "involvement",
                            "expected_value": "investigational product"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a serious concomitant systemic disorder.",
            "criterions": [
                {
                    "exact_snippets": "serious concomitant systemic disorder",
                    "criterion": "systemic disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "serious"
                        },
                        {
                            "requirement_type": "concomitance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have symptomatic central nervous system (CNS) malignancy or metastasis.",
            "criterions": [
                {
                    "exact_snippets": "symptomatic central nervous system (CNS) malignancy",
                    "criterion": "central nervous system (CNS) malignancy",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic central nervous system (CNS) ... metastasis",
                    "criterion": "central nervous system (CNS) metastasis",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.",
            "criterions": [
                {
                    "exact_snippets": "symptomatic Human Immunodeficiency Virus (HIV) infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic activated/reactivated hepatitis A, B, or C",
                    "criterion": "hepatitis A, B, or C",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activation/reactivation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.",
            "criterions": [
                {
                    "exact_snippets": "personal history of syncope",
                    "criterion": "personal history of syncope",
                    "requirements": [
                        {
                            "requirement_type": "etiology",
                            "expected_value": [
                                "unexplained",
                                "cardiovascular"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular tachycardia",
                    "criterion": "ventricular tachycardia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular fibrillation",
                    "criterion": "ventricular fibrillation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "sudden cardiac arrest",
                    "criterion": "sudden cardiac arrest",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have a history of any other cancer.",
            "criterions": [
                {
                    "exact_snippets": "Have a history of any other cancer.",
                    "criterion": "history of other cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had major surgery within 14 days prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Had major surgery within 14 days prior to randomization.",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Are breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Are breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.",
            "criterions": [
                {
                    "exact_snippets": "Have received treatment with a drug that has not received regulatory approval for any indication",
                    "criterion": "treatment with non-approved drug",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 14,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Have received treatment with a drug that has not received regulatory approval for any indication ... within ... 21 days of the initial dose of study drug for a ... myelosuppressive agent",
                    "criterion": "treatment with non-approved myelosuppressive drug",
                    "requirements": [
                        {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 21,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}