{
    "info": {
        "nct_id": "NCT03560531",
        "official_title": "A Phase 1/2 Open Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of ZN-c5 Alone and in Combination With Palbociclib in Subjects With Estrogen-Receptor Positive, Human Epidermal Growth Factor Receptor-2 Negative Advanced Breast Cancer",
        "inclusion_criteria": "* Age ≥ 18 years of age\n\n  * Women can be postmenopausal, as defined by at least one of the following:\n  * Age ≥ 60 years;\n  * Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females;\n  * Documented bilateral oophorectomy; or can be peri- or premenopausal, however, they must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication.\n* Histologically or cytologically confirmed diagnosis of advanced (metastatic or locoregionally recurrent) adenocarcinoma of the breast, not amenable to any potential curative intervention\n* Estrogen Receptor (ER) positive disease\n* Human Epidermal Growth Factor Receptor 2 (HER2) negative disease\n* Documented prior response to endocrine therapy for metastatic disease (stable disease, partial response, or complete response by RECIST v1.1 criteria) lasting > 6 months\n* Evaluable or measurable disease by RECIST v1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows:\n\n  * Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days before first dose of study treatment\n  * Any chemotherapy < 28 days before first dose of study, except for Phase 2 monotherapy which requires no prior chemotherapy treatment.\n  * Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment\n* Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years of age",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Women can be postmenopausal, as defined by at least one of the following:",
            "criterions": [
                {
                    "exact_snippets": "Women can be postmenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age ≥ 60 years;",
            "criterions": [
                {
                    "exact_snippets": "Age ≥ 60 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age < 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females;",
            "criterions": [
                {
                    "exact_snippets": "Age < 60 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "cessation of regular menses for at least 12 consecutive months",
                    "criterion": "cessation of regular menses",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no alternative pathological or physiological cause",
                    "criterion": "alternative pathological or physiological cause",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "serum estradiol ... within the laboratory's reference range for postmenopausal females",
                    "criterion": "serum estradiol level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the laboratory's reference range for postmenopausal females"
                        }
                    ]
                },
                {
                    "exact_snippets": "follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females",
                    "criterion": "follicle-stimulating hormone level",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "within the laboratory's reference range for postmenopausal females"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented bilateral oophorectomy; or can be peri- or premenopausal, however, they must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication.",
            "criterions": [
                {
                    "exact_snippets": "Documented bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "can be peri- or premenopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "peri-menopausal",
                                "premenopausal"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must receive a gonadotrophin-releasing hormone agonist beginning at least 4 weeks prior to the first dose of study medication",
                    "criterion": "gonadotrophin-releasing hormone agonist",
                    "requirements": [
                        {
                            "requirement_type": "administration timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed diagnosis of advanced (metastatic or locoregionally recurrent) adenocarcinoma of the breast, not amenable to any potential curative intervention",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed diagnosis",
                    "criterion": "diagnosis confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "advanced (metastatic or locoregionally recurrent) adenocarcinoma of the breast",
                    "criterion": "adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "metastatic",
                                "locoregionally recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not amenable to any potential curative intervention",
                    "criterion": "curative intervention amenability",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estrogen Receptor (ER) positive disease",
            "criterions": [
                {
                    "exact_snippets": "Estrogen Receptor (ER) positive disease",
                    "criterion": "Estrogen Receptor (ER) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human Epidermal Growth Factor Receptor 2 (HER2) negative disease",
            "criterions": [
                {
                    "exact_snippets": "Human Epidermal Growth Factor Receptor 2 (HER2) negative disease",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documented prior response to endocrine therapy for metastatic disease (stable disease, partial response, or complete response by RECIST v1.1 criteria) lasting > 6 months",
            "criterions": [
                {
                    "exact_snippets": "Documented prior response to endocrine therapy for metastatic disease",
                    "criterion": "prior response to endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stable disease, partial response, or complete response by RECIST v1.1 criteria",
                    "criterion": "response to endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "response type",
                            "expected_value": [
                                "stable disease",
                                "partial response",
                                "complete response"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "lasting > 6 months",
                    "criterion": "duration of response",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Evaluable or measurable disease by RECIST v1.1. Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if progression at the treated site after completion of therapy is clearly documented.",
            "criterions": [
                {
                    "exact_snippets": "Evaluable or measurable disease by RECIST v1.1.",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "evaluation method",
                            "expected_value": "RECIST v1.1"
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "evaluable",
                                "measurable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor lesions previously irradiated or subjected to other locoregional therapy ... deemed measurable if progression at the treated site after completion of therapy is clearly documented.",
                    "criterion": "tumor lesions",
                    "requirements": [
                        {
                            "requirement_type": "previous treatment",
                            "expected_value": [
                                "irradiated",
                                "locoregional therapy"
                            ]
                        },
                        {
                            "requirement_type": "measurability condition",
                            "expected_value": "progression at the treated site after completion of therapy is clearly documented"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer within the following windows:",
            "criterions": [
                {
                    "exact_snippets": "Prior anticancer or investigational drugs for the treatment of ER+/HER2 negative advanced breast cancer",
                    "criterion": "prior anticancer or investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "ER+/HER2 negative advanced breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days before first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Tamoxifen, aromatase inhibitor, fulvestrant, or other anti-cancer endocrine therapy < 14 days before first dose of study treatment",
                    "criterion": "anti-cancer endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any chemotherapy < 28 days before first dose of study, except for Phase 2 monotherapy which requires no prior chemotherapy treatment.",
            "criterions": [
                {
                    "exact_snippets": "Any chemotherapy < 28 days before first dose of study",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Phase 2 monotherapy ... requires no prior chemotherapy treatment",
                    "criterion": "prior chemotherapy treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Any investigational drug therapy < 28 days or 5 half-lives (whichever is shorter) prior to first dose of study treatment",
                    "criterion": "investigational drug therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 5,
                                        "unit": "half-lives"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unexplained symptomatic endometrial disorders (including, but not limited to endometrial hyperplasia, dysfunctional uterine bleeding, or cysts)",
            "criterions": [
                {
                    "exact_snippets": "Unexplained symptomatic endometrial disorders",
                    "criterion": "endometrial disorders",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "explanation",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "endometrial hyperplasia",
                    "criterion": "endometrial hyperplasia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dysfunctional uterine bleeding",
                    "criterion": "dysfunctional uterine bleeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cysts",
                    "criterion": "cysts",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}