{
    "info": {
        "nct_id": "NCT05979220",
        "official_title": "A Multicenter, Single Arm, Prospective Phase II Clinical Study of Dalpiciclib Combined With Letrozole in the Maintenance Treatment of HR Positive and HER2 Negative Metastatic Breast Cancer After First-line Chemotherapy",
        "inclusion_criteria": "1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.\n2. Age: 18 - 75 years old\n3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1\n4. Functions of liver and kidney is normal\n5. Agreed to take contraceptive measures during treatment\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "1. Confirmed diagnosis of HER2 positive disease.\n2. Central nervous system metastasis\n3. Patients who received prior treatment with any CDK4/6 inhibitor.\n4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention；\n5. Researchers believe that is not suitable for the study",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.",
            "criterions": [
                {
                    "exact_snippets": "pathologically-confirmed diagnosis",
                    "criterion": "diagnosis confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "locally recurrent or metastatic",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "locally recurrent",
                                "metastatic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "hormone-receptor positive",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative",
                    "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": "2. Age: 18 - 75 years old",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 - 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 75,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS)=0~1",
                    "criterion": "Eastern Cooperative Oncology Group performance status (ECOG PS)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Functions of liver and kidney is normal",
            "criterions": [
                {
                    "exact_snippets": "Functions of liver ... is normal",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Functions of ... kidney is normal",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Agreed to take contraceptive measures during treatment",
            "criterions": [
                {
                    "exact_snippets": "Agreed to take contraceptive measures during treatment",
                    "criterion": "contraceptive measures",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "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 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Confirmed diagnosis of HER2 positive disease.",
            "criterions": [
                {
                    "exact_snippets": "Confirmed diagnosis of HER2 positive disease",
                    "criterion": "HER2 positive disease",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Central nervous system metastasis",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system metastasis",
                    "criterion": "central nervous system metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who received prior treatment with any CDK4/6 inhibitor.",
            "criterions": [
                {
                    "exact_snippets": "Patients who received prior treatment with any CDK4/6 inhibitor",
                    "criterion": "prior treatment with CDK4/6 inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Clinically significant cardiovascular and cerebrovascular diseases,including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention；",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular and cerebrovascular diseases",
                    "criterion": "cardiovascular and cerebrovascular diseases",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "severe acute myocardial infarction within 6 months before enrollment",
                    "criterion": "acute myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 6 months before enrollment"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable or severe angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "unstable",
                                "severe"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Congestive heart failure (New York heart association (NYHA) class > 2)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "NYHA class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmia which need medical intervention",
                    "criterion": "ventricular arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Researchers believe that is not suitable for the study",
            "criterions": [
                {
                    "exact_snippets": "Researchers believe that is not suitable for the study",
                    "criterion": "suitability for the study",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}