{
    "info": {
        "nct_id": "NCT04191382",
        "official_title": "Phase 2 Window Study of Two Dose Levels of Amcenestrant [SAR439859] (SERD) Versus Letrozole in Newly Diagnosed Pre-operative Post-menopausal Patients With ER Positive, HER2 Negative Primary Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion criteria :\n\n* Histological or cytological proven diagnosis of invasive breast adenocarcinoma.\n* Localized breast cancer eligible for upfront breast conservative surgery or upfront mastectomy: Stage I, Stage II or operable Stage III (excluded T4) as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017.\n* Postmenopausal women as defined by one of the following:\n* Spontaneous cessation of menses greater than (>) 12 months.\n* or who had received hormonal replacement therapy but had discontinued the treatment and had follicle stimulating hormone (FSH) level in the postmenopausal range.\n* or with status post bilateral surgical oophorectomy.\n* or post bilateral ovarian ablation through pelvic radiotherapy.\n* Breast tumor size of at least 10 millimeters (mm) in greatest dimension measured by ultrasound.\n* Primary tumor had to be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor by immunohistochemistry.\n* Ki67 level of at least 15% at diagnosis from immunohistochemistry of the tumor.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n\nExclusion criteria:\n\n* Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859 or letrozole.\n* Participants unable to swallow normally and to take capsules or tablets.\n* Participants with known active hepatitis A, B, C infection; or hepatic cirrhosis.\n* Participant with any other cancer; adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant had been disease free for >3 years were allowed.\n* Evidence of metastatic spread by standard assessment according to local practice.\n* Treatment with strong Cytochrome P450 3A (CYP3A) inducers or drugs that had the potential to inhibit uridine diphosphate glucuronosyltransferase (UGT) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever was longest.\n* Treatment with drugs that were sensitive substrates of P-glycoprotein (P-gp) or of breast cancer resistance protein (BCRP) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever was longer.\n* Use of any investigational agent within 4 weeks prior to randomization.\n* Recent use of hormone replacement therapy (last dose less than or equal to [<=] 30 days prior to randomization).\n* Prior anti-cancer treatment was not allowed unless it was then completed at least 1 year prior to inclusion into this trial.\n* Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments).\n* Inadequate hematological or renal function.\n* Prothrombin time/international normalized ratio (INR) >1.5 * upper limit of normal (ULN) or outside therapeutic range if received anticoagulation that would have had affected the prothrombin time/INR.\n* Any of the following abnormal liver function test results: Aspartate aminotransferase >1.5 * ULN; Alanine aminotransferase >1.5 * ULN; Total bilirubin >1.5 * ULN.\n* Participants were employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.\n\nThe above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial."
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "identified_line": {
                "line": "* Histological or cytological proven diagnosis of invasive breast adenocarcinoma.",
                "criterions": [
                    {
                        "exact_snippets": "Histological or cytological proven diagnosis of invasive breast adenocarcinoma.",
                        "criterion": "invasive breast adenocarcinoma",
                        "requirement": {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Histological or cytological proven diagnosis of invasive breast adenocarcinoma.",
                        "criterion": "invasive breast adenocarcinoma",
                        "requirement": {
                            "requirement_type": "diagnosis method",
                            "expected_value": [
                                "histological",
                                "cytological"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Postmenopausal women as defined by one of the following:",
                "criterions": [
                    {
                        "exact_snippets": "Postmenopausal women",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Postmenopausal women",
                        "criterion": "menopausal status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "postmenopausal"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Spontaneous cessation of menses greater than (>) 12 months.",
                "criterions": [
                    {
                        "exact_snippets": "Spontaneous cessation of menses greater than (>) 12 months.",
                        "criterion": "cessation of menses",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Spontaneous cessation of menses greater than (>) 12 months.",
                        "criterion": "cessation of menses",
                        "requirement": {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* or who had received hormonal replacement therapy but had discontinued the treatment and had follicle stimulating hormone (FSH) level in the postmenopausal range.",
                "criterions": [
                    {
                        "exact_snippets": "received hormonal replacement therapy",
                        "criterion": "hormonal replacement therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "discontinued the treatment",
                        "criterion": "hormonal replacement therapy",
                        "requirement": {
                            "requirement_type": "current status",
                            "expected_value": "discontinued"
                        }
                    },
                    {
                        "exact_snippets": "follicle stimulating hormone (FSH) level in the postmenopausal range",
                        "criterion": "FSH level",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": "postmenopausal range"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "received hormonal replacement therapy",
                                "criterion": "hormonal replacement therapy",
                                "requirement": {
                                    "requirement_type": "history",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "discontinued the treatment",
                                "criterion": "hormonal replacement therapy",
                                "requirement": {
                                    "requirement_type": "current status",
                                    "expected_value": "discontinued"
                                }
                            },
                            {
                                "exact_snippets": "follicle stimulating hormone (FSH) level in the postmenopausal range",
                                "criterion": "FSH level",
                                "requirement": {
                                    "requirement_type": "range",
                                    "expected_value": "postmenopausal range"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* or with status post bilateral surgical oophorectomy.",
                "criterions": [
                    {
                        "exact_snippets": "status post bilateral surgical oophorectomy",
                        "criterion": "bilateral surgical oophorectomy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "status post bilateral surgical oophorectomy",
                        "criterion": "bilateral surgical oophorectomy",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* or post bilateral ovarian ablation through pelvic radiotherapy.",
                "criterions": [
                    {
                        "exact_snippets": "post bilateral ovarian ablation",
                        "criterion": "bilateral ovarian ablation",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "post"
                        }
                    },
                    {
                        "exact_snippets": "pelvic radiotherapy",
                        "criterion": "pelvic radiotherapy",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "radiotherapy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "post bilateral ovarian ablation",
                        "criterion": "bilateral ovarian ablation",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": "post"
                        }
                    },
                    {
                        "exact_snippets": "pelvic radiotherapy",
                        "criterion": "pelvic radiotherapy",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "radiotherapy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Breast tumor size of at least 10 millimeters (mm) in greatest dimension measured by ultrasound.",
                "criterions": [
                    {
                        "exact_snippets": "Breast tumor size of at least 10 millimeters (mm) in greatest dimension measured by ultrasound.",
                        "criterion": "breast tumor size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Breast tumor size of at least 10 millimeters (mm) in greatest dimension measured by ultrasound.",
                        "criterion": "breast tumor size",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Primary tumor had to be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor by immunohistochemistry.",
                "criterions": [
                    {
                        "exact_snippets": "Primary tumor had to be positive for Estrogen Receptors (ER+)",
                        "criterion": "Estrogen Receptors (ER)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "negative for HER2 (HER2-) receptor",
                        "criterion": "HER2 receptor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Primary tumor had to be positive for Estrogen Receptors (ER+)",
                        "criterion": "Estrogen Receptors (ER)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    },
                    {
                        "exact_snippets": "negative for HER2 (HER2-) receptor",
                        "criterion": "HER2 receptor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ki67 level of at least 15% at diagnosis from immunohistochemistry of the tumor.",
                "criterions": [
                    {
                        "exact_snippets": "Ki67 level of at least 15%",
                        "criterion": "Ki67 level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "%"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ki67 level of at least 15%",
                        "criterion": "Ki67 level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "%"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859 or letrozole.",
                "criterions": [
                    {
                        "exact_snippets": "Medical history or ongoing gastrointestinal disorders",
                        "criterion": "gastrointestinal disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "potentially affecting the absorption of SAR439859 or letrozole",
                        "criterion": "absorption of SAR439859 or letrozole",
                        "requirement": {
                            "requirement_type": "effect",
                            "expected_value": "potentially affecting"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Medical history or ongoing gastrointestinal disorders",
                        "criterion": "gastrointestinal disorders",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "potentially affecting the absorption of SAR439859 or letrozole",
                        "criterion": "absorption of SAR439859 or letrozole",
                        "requirement": {
                            "requirement_type": "effect",
                            "expected_value": "potentially affecting"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants unable to swallow normally and to take capsules or tablets.",
                "criterions": [
                    {
                        "exact_snippets": "Participants unable to swallow normally",
                        "criterion": "swallowing ability",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unable ... to take capsules or tablets",
                        "criterion": "ability to take capsules or tablets",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participants unable to swallow normally",
                        "criterion": "swallowing ability",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "unable ... to take capsules or tablets",
                        "criterion": "ability to take capsules or tablets",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants with known active hepatitis A, B, C infection; or hepatic cirrhosis.",
                "criterions": [
                    {
                        "exact_snippets": "known active hepatitis A",
                        "criterion": "hepatitis A infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known active hepatitis ... B",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known active hepatitis ... C",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatic cirrhosis",
                        "criterion": "hepatic cirrhosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "known active hepatitis A",
                        "criterion": "hepatitis A infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known active hepatitis ... B",
                        "criterion": "hepatitis B infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "known active hepatitis ... C",
                        "criterion": "hepatitis C infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "hepatic cirrhosis",
                        "criterion": "hepatic cirrhosis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participant with any other cancer; adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant had been disease free for >3 years were allowed.",
                "criterions": [
                    {
                        "exact_snippets": "Participant with any other cancer",
                        "criterion": "other cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adequately treated basal cell or squamous cell skin cancer",
                        "criterion": "basal cell or squamous cell skin cancer",
                        "requirement": {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    },
                    {
                        "exact_snippets": "in situ cervical cancer",
                        "criterion": "in situ cervical cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any other cancer from which the participant had been disease free for >3 years",
                        "criterion": "other cancer",
                        "requirement": {
                            "requirement_type": "disease-free duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "adequately treated basal cell or squamous cell skin cancer",
                                "criterion": "basal cell or squamous cell skin cancer",
                                "requirement": {
                                    "requirement_type": "treatment status",
                                    "expected_value": "adequately treated"
                                }
                            },
                            {
                                "exact_snippets": "in situ cervical cancer",
                                "criterion": "in situ cervical cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participant with any other cancer",
                                "criterion": "other cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "any other cancer from which the participant had been disease free for >3 years",
                                "criterion": "other cancer",
                                "requirement": {
                                    "requirement_type": "disease-free duration",
                                    "expected_value": {
                                        "operator": ">",
                                        "value": 3,
                                        "unit": "years"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evidence of metastatic spread by standard assessment according to local practice.",
                "criterions": [
                    {
                        "exact_snippets": "Evidence of metastatic spread",
                        "criterion": "metastatic spread",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Evidence of metastatic spread",
                        "criterion": "metastatic spread",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Treatment with strong Cytochrome P450 3A (CYP3A) inducers or drugs that had the potential to inhibit uridine diphosphate glucuronosyltransferase (UGT) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever was longest.",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with strong Cytochrome P450 3A (CYP3A) inducers",
                        "criterion": "treatment with strong CYP3A inducers",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "drugs that had the potential to inhibit uridine diphosphate glucuronosyltransferase (UGT)",
                        "criterion": "treatment with UGT inhibitors",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Treatment with strong Cytochrome P450 3A (CYP3A) inducers",
                                "criterion": "treatment with strong CYP3A inducers",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "drugs that had the potential to inhibit uridine diphosphate glucuronosyltransferase (UGT)",
                                "criterion": "treatment with UGT inhibitors",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Treatment with drugs that were sensitive substrates of P-glycoprotein (P-gp) or of breast cancer resistance protein (BCRP) within 2 weeks before first study treatment administration or 5 elimination half-lives whichever was longer.",
                "criterions": [
                    {
                        "exact_snippets": "Treatment with drugs that were sensitive substrates of P-glycoprotein (P-gp)",
                        "criterion": "treatment with P-glycoprotein (P-gp) substrates",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Treatment with drugs that were sensitive substrates of ... breast cancer resistance protein (BCRP)",
                        "criterion": "treatment with breast cancer resistance protein (BCRP) substrates",
                        "requirement": {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Treatment with drugs that were sensitive substrates of P-glycoprotein (P-gp)",
                                "criterion": "treatment with P-glycoprotein (P-gp) substrates",
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                                    "requirement_type": "time since last treatment",
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                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "weeks"
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                                        ]
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                                }
                            },
                            {
                                "exact_snippets": "Treatment with drugs that were sensitive substrates of P-glycoprotein (P-gp)",
                                "criterion": "treatment with P-glycoprotein (P-gp) substrates",
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                                    "requirement_type": "time since last treatment",
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                                            {
                                                "operator": ">=",
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                                                "unit": "elimination half-lives"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Treatment with drugs that were sensitive substrates of ... breast cancer resistance protein (BCRP)",
                                "criterion": "treatment with breast cancer resistance protein (BCRP) substrates",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "weeks"
                                            }
                                        ]
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Treatment with drugs that were sensitive substrates of ... breast cancer resistance protein (BCRP)",
                                "criterion": "treatment with breast cancer resistance protein (BCRP) substrates",
                                "requirement": {
                                    "requirement_type": "time since last treatment",
                                    "expected_value": {
                                        "comparisons": [
                                            {
                                                "operator": ">=",
                                                "value": 5,
                                                "unit": "elimination half-lives"
                                            }
                                        ]
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Use of any investigational agent within 4 weeks prior to randomization.",
                "criterions": [
                    {
                        "exact_snippets": "Use of any investigational agent within 4 weeks prior to randomization.",
                        "criterion": "use of investigational agent",
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                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Use of any investigational agent within 4 weeks prior to randomization.",
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                        "requirement_type": "time since last use",
                        "expected_value": {
                            "operator": ">=",
                            "value": 4,
                            "unit": "weeks"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Recent use of hormone replacement therapy (last dose less than or equal to [<=] 30 days prior to randomization).",
                "criterions": [
                    {
                        "exact_snippets": "Recent use of hormone replacement therapy (last dose less than or equal to [<=] 30 days prior to randomization)",
                        "criterion": "hormone replacement therapy",
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                            "requirement_type": "recent use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Recent use of hormone replacement therapy (last dose less than or equal to [<=] 30 days prior to randomization)",
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                            "requirement_type": "recent use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prior anti-cancer treatment was not allowed unless it was then completed at least 1 year prior to inclusion into this trial.",
                "criterions": [
                    {
                        "exact_snippets": "Prior anti-cancer treatment was not allowed unless it was then completed at least 1 year prior to inclusion",
                        "criterion": "prior anti-cancer treatment",
                        "requirement": {
                            "requirement_type": "completion time",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "exact_snippets": "Prior anti-cancer treatment was not allowed unless it was then completed at least 1 year prior to inclusion",
                    "criterion": "prior anti-cancer treatment",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": false
                    }
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "Prior anti-cancer treatment was not allowed unless it was then completed at least 1 year prior to inclusion",
                    "criterion": "prior anti-cancer treatment",
                    "requirement": {
                        "requirement_type": "completion time",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1,
                            "unit": "year"
                        }
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "* Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments).",
                "criterions": [
                    {
                        "exact_snippets": "Previous systemic or local treatment for the new primary breast cancer",
                        "criterion": "previous treatment for new primary breast cancer",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "systemic",
                                "local"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "(including surgery, radiotherapy, cytotoxic and endocrine treatments)",
                        "criterion": "types of previous treatment",
                        "requirement": {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "surgery",
                                "radiotherapy",
                                "cytotoxic",
                                "endocrine"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Previous systemic or local treatment for the new primary breast cancer",
                                "criterion": "previous treatment for new primary breast cancer",
                                "requirement": {
                                    "requirement_type": "treatment type",
                                    "expected_value": [
                                        "systemic",
                                        "local"
                                    ]
                                }
                            },
                            {
                                "exact_snippets": "(including surgery, radiotherapy, cytotoxic and endocrine treatments)",
                                "criterion": "types of previous treatment",
                                "requirement": {
                                    "requirement_type": "treatment type",
                                    "expected_value": [
                                        "surgery",
                                        "radiotherapy",
                                        "cytotoxic",
                                        "endocrine"
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Inadequate hematological or renal function.",
                "criterions": [
                    {
                        "exact_snippets": "Inadequate hematological ... function.",
                        "criterion": "hematological function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Inadequate ... renal function.",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Inadequate hematological ... function.",
                        "criterion": "hematological function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Inadequate ... renal function.",
                        "criterion": "renal function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Prothrombin time/international normalized ratio (INR) >1.5 * upper limit of normal (ULN) or outside therapeutic range if received anticoagulation that would have had affected the prothrombin time/INR.",
                "criterions": [
                    {
                        "exact_snippets": "Prothrombin time/international normalized ratio (INR) >1.5 * upper limit of normal (ULN)",
                        "criterion": "prothrombin time/INR",
                        "requirement": {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "outside therapeutic range if received anticoagulation",
                        "criterion": "prothrombin time/INR",
                        "requirement": {
                            "requirement_type": "therapeutic range",
                            "expected_value": "outside"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Prothrombin time/international normalized ratio (INR) >1.5 * upper limit of normal (ULN)",
                                "criterion": "prothrombin time/INR",
                                "requirement": {
                                    "requirement_type": "comparison",
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                                        "operator": ">",
                                        "value": 1.5,
                                        "unit": "* ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "outside therapeutic range if received anticoagulation",
                                "criterion": "prothrombin time/INR",
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                                    "requirement_type": "therapeutic range",
                                    "expected_value": "outside"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Any of the following abnormal liver function test results: Aspartate aminotransferase >1.5 * ULN; Alanine aminotransferase >1.5 * ULN; Total bilirubin >1.5 * ULN.",
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                    {
                        "exact_snippets": "Aspartate aminotransferase >1.5 * ULN",
                        "criterion": "Aspartate aminotransferase",
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                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase >1.5 * ULN",
                        "criterion": "Alanine aminotransferase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin >1.5 * ULN",
                        "criterion": "Total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* ULN"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Aspartate aminotransferase >1.5 * ULN",
                        "criterion": "Aspartate aminotransferase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Alanine aminotransferase >1.5 * ULN",
                        "criterion": "Alanine aminotransferase",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Total bilirubin >1.5 * ULN",
                        "criterion": "Total bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "* ULN"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Participants were employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.",
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                    {
                        "exact_snippets": "Participants were employees of the clinical study site",
                        "criterion": "employment status",
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                            "requirement_type": "employment",
                            "expected_value": "employee of the clinical study site"
                        }
                    },
                    {
                        "exact_snippets": "other individuals directly involved in the conduct of the study",
                        "criterion": "involvement in study",
                        "requirement": {
                            "requirement_type": "involvement",
                            "expected_value": "directly involved in the conduct of the study"
                        }
                    },
                    {
                        "exact_snippets": "immediate family members of such individuals",
                        "criterion": "relationship to study personnel",
                        "requirement": {
                            "requirement_type": "relationship",
                            "expected_value": "immediate family member"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Participants were employees of the clinical study site",
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                                "requirement": {
                                    "requirement_type": "employment",
                                    "expected_value": "employee of the clinical study site"
                                }
                            },
                            {
                                "exact_snippets": "immediate family members of such individuals",
                                "criterion": "relationship to study personnel",
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                                    "requirement_type": "relationship",
                                    "expected_value": "immediate family member"
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other individuals directly involved in the conduct of the study",
                                "criterion": "involvement in study",
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                                    "requirement_type": "involvement",
                                    "expected_value": "directly involved in the conduct of the study"
                                }
                            },
                            {
                                "exact_snippets": "immediate family members of such individuals",
                                "criterion": "relationship to study personnel",
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                                    "requirement_type": "relationship",
                                    "expected_value": "immediate family member"
                                }
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                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Inclusion criteria :",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "Exclusion criteria:",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        },
        {
            "identified_line": {
                "line": "The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",
                "criterions": []
            },
            "logical_structure": {
                "and_criteria": []
            }
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "identified_line": {
                "line": "* Localized breast cancer eligible for upfront breast conservative surgery or upfront mastectomy: Stage I, Stage II or operable Stage III (excluded T4) as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017.",
                "criterions": [
                    {
                        "exact_snippets": "Localized breast cancer",
                        "criterion": "breast cancer",
                        "requirement": {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    },
                    {
                        "exact_snippets": "eligible for upfront breast conservative surgery or upfront mastectomy",
                        "criterion": "surgical eligibility",
                        "requirement": {
                            "requirement_type": "surgery type",
                            "expected_value": [
                                "breast conservative surgery",
                                "mastectomy"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Stage I, Stage II or operable Stage III (excluded T4)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "stage",
                            "expected_value": [
                                "Stage I",
                                "Stage II",
                                "operable Stage III"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Stage I, Stage II or operable Stage III (excluded T4)",
                        "criterion": "cancer stage",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": "T4"
                        }
                    },
                    {
                        "exact_snippets": "as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017",
                        "criterion": "cancer staging definition",
                        "requirement": {
                            "requirement_type": "reference",
                            "expected_value": "AJCC Cancer Staging Manual 8th edition 2017"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Localized breast cancer",
                                                "criterion": "breast cancer",
                                                "requirement": {
                                                    "requirement_type": "localization",
                                                    "expected_value": "localized"
                                                }
                                            },
                                            {
                                                "exact_snippets": "eligible for upfront breast conservative surgery or upfront mastectomy",
                                                "criterion": "surgical eligibility",
                                                "requirement": {
                                                    "requirement_type": "surgery type",
                                                    "expected_value": [
                                                        "breast conservative surgery",
                                                        "mastectomy"
                                                    ]
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "or_criteria": [
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                                                "exact_snippets": "Stage I, Stage II or operable Stage III (excluded T4)",
                                                "criterion": "cancer stage",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": "Stage I"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Stage I, Stage II or operable Stage III (excluded T4)",
                                                "criterion": "cancer stage",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": "Stage II"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Stage I, Stage II or operable Stage III (excluded T4)",
                                                "criterion": "cancer stage",
                                                "requirement": {
                                                    "requirement_type": "stage",
                                                    "expected_value": "operable Stage III"
                                                }
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                                        ]
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "Stage I, Stage II or operable Stage III (excluded T4)",
                                "criterion": "cancer stage",
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                                    "requirement_type": "exclusion",
                                    "expected_value": "T4"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017",
                        "criterion": "cancer staging definition",
                        "requirement": {
                            "requirement_type": "reference",
                            "expected_value": "AJCC Cancer Staging Manual 8th edition 2017"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study.",
                "criterions": [
                    {
                        "exact_snippets": "Sensitivity to any of the study interventions, or components thereof",
                        "criterion": "sensitivity to study interventions",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study",
                        "criterion": "drug or other allergy",
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                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Sensitivity to any of the study interventions, or components thereof",
                                "criterion": "sensitivity to study interventions",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study",
                                "criterion": "drug or other allergy",
                                "requirement": {
                                    "requirement_type": "contraindication",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ]
}