{
    "info": {
        "nct_id": "NCT06686394",
        "official_title": "HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer",
        "inclusion_criteria": "The main inclusion criteria include but are not limited to the following:\n\n* Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer\n* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation\n* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention\n\nArm 1:\n\n* Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n* Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment\n\nArm 2:\n\n-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting\n\nArm 3:\n\n-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "The main exclusion criteria include but are not limited to the following:\n\n* Uncontrolled or significant cardiovascular disease\n* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease\n* Has clinically severe respiratory compromise\n* Has any history of or evidence of any current leptomeningeal disease\n* Has clinically significant corneal disease\n* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection\n* HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease\n* Known additional malignancy that is progressing or has required active treatment within the past 3 years\n* Evidence of spinal cord compression or brain metastases\n* Has an active infection requiring systemic therapy\n* Concurrent active HBV and HCV infection\n* Has had major surgical procedure (excluding placement of vascular access) less than 28 days\n\nArm 3 ONLY\n\n- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "The main inclusion criteria include but are not limited to the following:",
            "criterions": [
                {
                    "exact_snippets": "main inclusion criteria",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "main"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has histologically confirmed HER2+ locally advanced unresectable breast cancer or metastatic breast cancer",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed HER2+",
                    "criterion": "HER2+ status",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced unresectable breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        },
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART)",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV)-infected participants",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "well-controlled HIV on antiretroviral therapy (ART)",
                    "criterion": "HIV control",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "well-controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "on antiretroviral therapy (ART)",
                    "criterion": "antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable hepatitis B virus (HBV) viral load before allocation",
            "criterions": [
                {
                    "exact_snippets": "hepatitis B surface antigen (HBsAg) positive",
                    "criterion": "hepatitis B surface antigen (HBsAg)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "received HBV antiviral therapy for at least 4 weeks",
                    "criterion": "HBV antiviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable hepatitis B virus (HBV) viral load",
                    "criterion": "hepatitis B virus (HBV) viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable",
            "criterions": [
                {
                    "exact_snippets": "history of hepatitis C virus (HCV) infection",
                    "criterion": "hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HCV viral load is undetectable",
                    "criterion": "HCV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1 within 7 days before start of study intervention",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 7 days before start of study intervention",
                    "criterion": "timeframe for ECOG assessment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 7 days before start of study intervention"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting",
            "criterions": [
                {
                    "exact_snippets": "received at least a minimum of 2 and a maximum of 5 prior lines of anti-HER2 therapy",
                    "criterion": "prior lines of anti-HER2 therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "in the locally advanced or metastatic setting",
                    "criterion": "disease setting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment",
            "criterions": [
                {
                    "exact_snippets": "disease progression on or after any previous trastuzumab deruxtecan (T-DXd) treatment",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "on or after any previous trastuzumab deruxtecan (T-DXd) treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "-Has received no more than 5 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting",
            "criterions": [
                {
                    "exact_snippets": "no more than 5 prior lines of anti-HER2 therapy",
                    "criterion": "prior lines of anti-HER2 therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "locally advanced or metastatic setting",
                    "criterion": "disease setting",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "-Has received and had disease progression from T-DXd treatment in any setting and a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting. T-DXd must be the most recent therapy received before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Has received and had disease progression from T-DXd treatment",
                    "criterion": "T-DXd treatment",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a maximum of 3 prior lines of anti-HER2 therapy in the locally advanced or metastatic setting",
                    "criterion": "prior lines of anti-HER2 therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T-DXd must be the most recent therapy received before enrollment",
                    "criterion": "most recent therapy",
                    "requirements": [
                        {
                            "requirement_type": "therapy type",
                            "expected_value": "T-DXd"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Uncontrolled or significant cardiovascular disease",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled or significant cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "History of (noninfectious) pneumonitis/interstitial lung disease (ILD)",
                    "criterion": "history of pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that required steroids",
                    "criterion": "pneumonitis/interstitial lung disease requiring steroids",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "current pneumonitis/interstitial lung disease",
                    "criterion": "current pneumonitis/interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has clinically severe respiratory compromise",
            "criterions": [
                {
                    "exact_snippets": "clinically severe respiratory compromise",
                    "criterion": "respiratory compromise",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically severe"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has any history of or evidence of any current leptomeningeal disease",
            "criterions": [
                {
                    "exact_snippets": "any history of or evidence of any current leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "current presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has clinically significant corneal disease",
            "criterions": [
                {
                    "exact_snippets": "clinically significant corneal disease",
                    "criterion": "corneal disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection",
            "criterions": [
                {
                    "exact_snippets": "ongoing uncontrolled systemic bacterial ... infection",
                    "criterion": "systemic bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing uncontrolled systemic ... fungal ... infection",
                    "criterion": "systemic fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing uncontrolled systemic ... viral infection",
                    "criterion": "systemic viral infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease",
            "criterions": [
                {
                    "exact_snippets": "HIV infected participants",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of Kaposi's sarcoma",
                    "criterion": "Kaposi's sarcoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... Multicentric Castleman's Disease",
                    "criterion": "Multicentric Castleman's Disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known additional malignancy that is progressing or has required active treatment within the past 3 years",
            "criterions": [
                {
                    "exact_snippets": "Known additional malignancy",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evidence of spinal cord compression or brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Evidence of spinal cord compression",
                    "criterion": "spinal cord compression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Evidence of ... brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Concurrent active HBV and HCV infection",
            "criterions": [
                {
                    "exact_snippets": "Concurrent active HBV",
                    "criterion": "HBV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Concurrent active ... HCV infection",
                    "criterion": "HCV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had major surgical procedure (excluding placement of vascular access) less than 28 days",
            "criterions": [
                {
                    "exact_snippets": "Has had major surgical procedure ... less than 28 days",
                    "criterion": "major surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Arm 3 ONLY",
            "criterions": [
                {
                    "exact_snippets": "Arm 3 ONLY",
                    "criterion": "trial arm",
                    "requirements": [
                        {
                            "requirement_type": "specific arm",
                            "expected_value": "Arm 3"
                        }
                    ]
                }
            ]
        },
        {
            "line": "- Has received prior treatment with tucatinib, lapatinib, or neratinib, or any investigational HER2-targeted tyrosine kinase inhibitors in the locally advanced or metastatic setting",
            "criterions": [
                {
                    "exact_snippets": "Has received prior treatment with tucatinib",
                    "criterion": "prior treatment with tucatinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior treatment with ... lapatinib",
                    "criterion": "prior treatment with lapatinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior treatment with ... neratinib",
                    "criterion": "prior treatment with neratinib",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior treatment with ... any investigational HER2-targeted tyrosine kinase inhibitors",
                    "criterion": "prior treatment with investigational HER2-targeted tyrosine kinase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in the locally advanced or metastatic setting",
                    "criterion": "treatment setting",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "locally advanced",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "Arm 1:",
            "criterions": []
        },
        {
            "line": "Arm 2:",
            "criterions": []
        },
        {
            "line": "Arm 3:",
            "criterions": []
        }
    ],
    "failed_exclusion": [
        {
            "line": "The main exclusion criteria include but are not limited to the following:",
            "criterions": []
        }
    ],
    "failed_miscellaneous": []
}