{
    "info": {
        "nct_id": "NCT06210776",
        "official_title": "A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Patients must meet all of the following inclusion criteria to be eligible for the study:\n\n1. ≥18 years of age at time of consent.\n2. Pathologically documented breast cancer that is unresectable or metastatic.\n3. Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings.\n\n   Cohort B: Patients with confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-); and patients have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; and patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings.\n4. Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China.\n5. Capable of providing informed consent.\n6. Patients capable of completing questionnaires are preferred. If the participant is unable to complete the questionnaire (e.g., being blind, illiterate, not fluent in the available language, or ePRO system is not ready), that participant is exempted from completing PRO questionnaires but may still participate in the study.\n\nPatients who meet any of the following criteria will be excluded from the study:\n\n1. Pregnancy or breastfeeding.\n2. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.\n3. Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.\n4. Patients who have been judged by the investigator to be unfit to participate the study."
    },
    "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 have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. ≥18 years of age at time of consent.",
            "criterions": [
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Pathologically documented breast cancer that is unresectable or metastatic.",
            "criterions": [
                {
                    "exact_snippets": "Pathologically documented breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "pathologically documented"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "breast cancer resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic",
                    "criterion": "breast cancer metastasis",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Cohort A: Patients with confirmed HER2+ (IHC 3+ or IHC2+, ISH+); and patients have received one or more prior anti-HER2-based regimens; and patients should have received no more than 2 lines therapy in the metastatic settings.",
            "criterions": [
                {
                    "exact_snippets": "confirmed HER2+ (IHC 3+ or IHC2+, ISH+)",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "HER2+ (IHC 3+ or IHC2+, ISH+)"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients have received one or more prior anti-HER2-based regimens",
                    "criterion": "prior anti-HER2-based regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients should have received no more than 2 lines therapy in the metastatic settings",
                    "criterion": "lines of therapy in metastatic settings",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Cohort B: Patients with confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-); and patients have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; and patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings.",
            "criterions": [
                {
                    "exact_snippets": "confirmed HER2-low expression (IHC 1+ or IHC 2+, ISH-)",
                    "criterion": "HER2 expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": [
                                "IHC 1+",
                                "IHC 2+"
                            ]
                        },
                        {
                            "requirement_type": "ISH status",
                            "expected_value": "ISH-"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients have received at least a prior systemic therapy in the metastatic setting",
                    "criterion": "prior systemic therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "therapy"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "developed disease recurrence during or within 6 months of completing adjuvant chemotherapy",
                    "criterion": "disease recurrence",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "during or within 6 months of completing adjuvant chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "patients should have received no more than 2 lines of previous chemotherapy regimen in the metastatic settings",
                    "criterion": "previous chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Decision to newly initiate T-DXd or just have started the first dose no longer than 14 days after the index date per approved label in China.",
            "criterions": [
                {
                    "exact_snippets": "Decision to newly initiate T-DXd",
                    "criterion": "T-DXd initiation",
                    "requirements": [
                        {
                            "requirement_type": "initiation status",
                            "expected_value": "newly initiate"
                        }
                    ]
                },
                {
                    "exact_snippets": "just have started the first dose no longer than 14 days after the index date",
                    "criterion": "T-DXd initiation",
                    "requirements": [
                        {
                            "requirement_type": "initiation status",
                            "expected_value": "just started"
                        },
                        {
                            "requirement_type": "time since first dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Capable of providing informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Capable of providing informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients capable of completing questionnaires are preferred. If the participant is unable to complete the questionnaire (e.g., being blind, illiterate, not fluent in the available language, or ePRO system is not ready), that participant is exempted from completing PRO questionnaires but may still participate in the study.",
            "criterions": [
                {
                    "exact_snippets": "Patients capable of completing questionnaires",
                    "criterion": "ability to complete questionnaires",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "being blind",
                    "criterion": "vision",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "not blind"
                        }
                    ]
                },
                {
                    "exact_snippets": "illiterate",
                    "criterion": "literacy",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "literate"
                        }
                    ]
                },
                {
                    "exact_snippets": "not fluent in the available language",
                    "criterion": "language fluency",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "fluent in the available language"
                        }
                    ]
                },
                {
                    "exact_snippets": "ePRO system is not ready",
                    "criterion": "ePRO system readiness",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": "ready"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Pregnancy or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients who at time of data collection for this study are participating in or have participated in an interventional study that remains blinded.",
            "criterions": [
                {
                    "exact_snippets": "Patients who ... are participating in ... an interventional study",
                    "criterion": "participation in interventional study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who ... have participated in an interventional study",
                    "criterion": "past participation in interventional study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "study that remains blinded",
                    "criterion": "study blinding status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "blinded"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who have known to have hypersensitivity reactions to the active substance of T-DXd or any excipients.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity reactions to the active substance of T-DXd",
                    "criterion": "hypersensitivity to T-DXd",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity reactions to ... any excipients",
                    "criterion": "hypersensitivity to excipients",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patients who have been judged by the investigator to be unfit to participate the study.",
            "criterions": [
                {
                    "exact_snippets": "judged by the investigator to be unfit to participate the study",
                    "criterion": "fitness to participate",
                    "requirements": [
                        {
                            "requirement_type": "judgment",
                            "expected_value": "fit"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Patients must meet all of the following inclusion criteria to be eligible for the study:",
            "criterions": []
        },
        {
            "line": "Patients who meet any of the following criteria will be excluded from the study:",
            "criterions": []
        }
    ]
}