{
    "info": {
        "nct_id": "NCT03917082",
        "official_title": "LA LEAST- Luminal A, Limited Endocrine Adjuvant Systemic Therapy. A Trial of Abbreviated Hormone Therapy for Low Risk Hormone Receptor Positive, HER2 Negative Early Breast Cancer",
        "inclusion_criteria": "for Prosigna® screening\n\n* Diagnosis of invasive breast cancer which is:\n\n  * Unifocal or multifocal (not multicentric)\n  * Unilateral\n  * Moderate or strongly hormone receptor positive\n  * HER2 negative\n  * Ductal grade 1 or 2, or lobular any grade, or pure tubular (any grade) or pure papillary (any grade). If mixed lobular-ductal histology, the ductal component must be grade 1 or 2.\n  * Stage pT1N0 (tumor </= 20mm, negative node) or pT2N0 (tumor 21-50mm, node negative) or pT1N0i+ (tumor </=20mm and isolated tumor cells in node[s]) or pT2N0i+ (tumor 21-50mm and isolated tumor cells in node[s]) (see Appendix 2). Tumor size must be sufficient for Prosigna® testing. pNX (nodal status unknown) stage is not eligible.\n* Subject must be female\n* Subject must be age > 50 years at breast cancer diagnosis\n* Subject may be pre, peri, or postmenopausal.\n* Subject must have a > 5-year life expectancy based on physician judgement of subject's co-morbid illnesses and age\n* Subject must undergo standard of care loco-regional management (sentinel node biopsy and/or axillary dissection; breast conserving surgery or mastectomy; radiation to breast following breast conserving surgery, with radiotherapy details per local institution practice). Surgery will have been no more than 24 weeks prior to endocrine therapy start. Subjects having repeat surgeries after radiation, regardless of indication, should count the date of last surgery that preceded radiation. Subjects may undergo Prosigna® screening prior to completion of radiation.\n* The breast surgery will have achieved negative surgical margins. Tumours with positive margins that are not re-resectable are eligible if followed by radiation with a boost (partial mastectomy) or chest wall radiation (mastectomy)\n* No (neoadjuvant or adjuvant) chemotherapy given or planned for this breast cancer\n* No other non-breast cancer within the last 5 years, except non-melanoma skin cancer, melanoma in situ, cervix carcinoma in situ, and anal carcinoma in situ\n* No prior hormone receptor positive invasive breast cancer. Prior contralateral DCIS treated with standard of care local therapy, and prior lobular carcinoma in situ (LCIS) are allowed, provided no endocrine therapy with any of tamoxifen, ovarian suppression, raloxifene, or aromatase inhibitor was given\n* Subject will have not have started endocrine therapy prior to enrollment\n* Subject has signed a screening informed consent form\n* Subject has intent to be adherent to endocrine therapy for two years in the absence of serious toxicity\n\nInclusion criteria for study enrollment:\n\n* Prosigna® score in the low risk range, defined as an ROR of 40 or lower\n* Subject has not yet initiated endocrine therapy\n* Subject has signed study informed consent form\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 51 Years",
        "exclusion_criteria": "• Does not meet every inclusion criteria listed above",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "for Prosigna® screening",
            "criterions": [
                {
                    "exact_snippets": "Prosigna® screening",
                    "criterion": "Prosigna® screening",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of invasive breast cancer which is:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of invasive breast cancer",
                    "criterion": "invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unifocal or multifocal (not multicentric)",
            "criterions": [
                {
                    "exact_snippets": "Unifocal or multifocal (not multicentric)",
                    "criterion": "tumor focality",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "unifocal",
                                "multifocal"
                            ]
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "multicentric"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unilateral",
            "criterions": [
                {
                    "exact_snippets": "Unilateral",
                    "criterion": "laterality",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "unilateral"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate or strongly hormone receptor positive",
            "criterions": [
                {
                    "exact_snippets": "Moderate or strongly hormone receptor positive",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "moderate",
                                "strongly positive"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2 negative",
            "criterions": [
                {
                    "exact_snippets": "HER2 negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ductal grade 1 or 2, or lobular any grade, or pure tubular (any grade) or pure papillary (any grade). If mixed lobular-ductal histology, the ductal component must be grade 1 or 2.",
            "criterions": [
                {
                    "exact_snippets": "Ductal grade 1 or 2",
                    "criterion": "ductal grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "1",
                                "2"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "lobular any grade",
                    "criterion": "lobular grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "pure tubular (any grade)",
                    "criterion": "pure tubular grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "pure papillary (any grade)",
                    "criterion": "pure papillary grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": "any"
                        }
                    ]
                },
                {
                    "exact_snippets": "mixed lobular-ductal histology ... ductal component must be grade 1 or 2",
                    "criterion": "mixed lobular-ductal histology ductal component grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must be female",
            "criterions": [
                {
                    "exact_snippets": "Subject must be female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must be age > 50 years at breast cancer diagnosis",
            "criterions": [
                {
                    "exact_snippets": "age > 50 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "breast cancer diagnosis",
                    "criterion": "breast cancer diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject may be pre, peri, or postmenopausal.",
            "criterions": [
                {
                    "exact_snippets": "Subject may be pre, peri, or postmenopausal.",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "premenopausal",
                                "perimenopausal",
                                "postmenopausal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must have a > 5-year life expectancy based on physician judgement of subject's co-morbid illnesses and age",
            "criterions": [
                {
                    "exact_snippets": "Subject must have a > 5-year life expectancy",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "physician judgement of subject's co-morbid illnesses",
                    "criterion": "co-morbid illnesses",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "physician judgement"
                        }
                    ]
                },
                {
                    "exact_snippets": "physician judgement of subject's ... age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "assessment",
                            "expected_value": "physician judgement"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject must undergo standard of care loco-regional management (sentinel node biopsy and/or axillary dissection; breast conserving surgery or mastectomy; radiation to breast following breast conserving surgery, with radiotherapy details per local institution practice). Surgery will have been no more than 24 weeks prior to endocrine therapy start. Subjects having repeat surgeries after radiation, regardless of indication, should count the date of last surgery that preceded radiation. Subjects may undergo Prosigna® screening prior to completion of radiation.",
            "criterions": [
                {
                    "exact_snippets": "Subject must undergo standard of care loco-regional management (sentinel node biopsy and/or axillary dissection; breast conserving surgery or mastectomy; radiation to breast following breast conserving surgery, with radiotherapy details per local institution practice).",
                    "criterion": "loco-regional management",
                    "requirements": [
                        {
                            "requirement_type": "procedures",
                            "expected_value": [
                                "sentinel node biopsy",
                                "axillary dissection",
                                "breast conserving surgery",
                                "mastectomy",
                                "radiation to breast"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Surgery will have been no more than 24 weeks prior to endocrine therapy start.",
                    "criterion": "surgery timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 24,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects having repeat surgeries after radiation, regardless of indication, should count the date of last surgery that preceded radiation.",
                    "criterion": "repeat surgeries after radiation",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "date of last surgery that preceded radiation"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects may undergo Prosigna® screening prior to completion of radiation.",
                    "criterion": "Prosigna® screening",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to completion of radiation"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The breast surgery will have achieved negative surgical margins. Tumours with positive margins that are not re-resectable are eligible if followed by radiation with a boost (partial mastectomy) or chest wall radiation (mastectomy)",
            "criterions": [
                {
                    "exact_snippets": "The breast surgery will have achieved negative surgical margins.",
                    "criterion": "surgical margins",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumours with positive margins that are not re-resectable are eligible if followed by radiation with a boost (partial mastectomy) or chest wall radiation (mastectomy)",
                    "criterion": "tumours with positive margins",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "radiation with a boost (partial mastectomy)",
                                "chest wall radiation (mastectomy)"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No (neoadjuvant or adjuvant) chemotherapy given or planned for this breast cancer",
            "criterions": [
                {
                    "exact_snippets": "No (neoadjuvant or adjuvant) chemotherapy given or planned",
                    "criterion": "chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No other non-breast cancer within the last 5 years, except non-melanoma skin cancer, melanoma in situ, cervix carcinoma in situ, and anal carcinoma in situ",
            "criterions": [
                {
                    "exact_snippets": "No other non-breast cancer within the last 5 years",
                    "criterion": "non-breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except non-melanoma skin cancer, melanoma in situ, cervix carcinoma in situ, and anal carcinoma in situ",
                    "criterion": "specific cancer types",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "non-melanoma skin cancer",
                                "melanoma in situ",
                                "cervix carcinoma in situ",
                                "anal carcinoma in situ"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior hormone receptor positive invasive breast cancer. Prior contralateral DCIS treated with standard of care local therapy, and prior lobular carcinoma in situ (LCIS) are allowed, provided no endocrine therapy with any of tamoxifen, ovarian suppression, raloxifene, or aromatase inhibitor was given",
            "criterions": [
                {
                    "exact_snippets": "No prior hormone receptor positive invasive breast cancer",
                    "criterion": "prior hormone receptor positive invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior contralateral DCIS treated with standard of care local therapy",
                    "criterion": "prior contralateral DCIS",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "standard of care local therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "prior lobular carcinoma in situ (LCIS) are allowed",
                    "criterion": "prior lobular carcinoma in situ (LCIS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provided no endocrine therapy with any of tamoxifen, ovarian suppression, raloxifene, or aromatase inhibitor was given",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "medications",
                            "expected_value": [
                                "tamoxifen",
                                "ovarian suppression",
                                "raloxifene",
                                "aromatase inhibitor"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject will have not have started endocrine therapy prior to enrollment",
            "criterions": [
                {
                    "exact_snippets": "Subject will have not have started endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has signed a screening informed consent form",
            "criterions": [
                {
                    "exact_snippets": "Subject has signed a screening informed consent form",
                    "criterion": "screening informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has intent to be adherent to endocrine therapy for two years in the absence of serious toxicity",
            "criterions": [
                {
                    "exact_snippets": "intent to be adherent to endocrine therapy for two years",
                    "criterion": "adherence to endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "=",
                                "value": 2,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "absence of serious toxicity",
                    "criterion": "serious toxicity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prosigna® score in the low risk range, defined as an ROR of 40 or lower",
            "criterions": [
                {
                    "exact_snippets": "Prosigna® score ... ROR of 40 or lower",
                    "criterion": "Prosigna® score",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 40,
                                        "unit": "ROR"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has not yet initiated endocrine therapy",
            "criterions": [
                {
                    "exact_snippets": "Subject has not yet initiated endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "initiation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has signed study informed consent form",
            "criterions": [
                {
                    "exact_snippets": "Subject has signed study informed consent form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 51 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 51 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 51,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "• Does not meet every inclusion criteria listed above",
            "criterions": [
                {
                    "exact_snippets": "Does not meet every inclusion criteria",
                    "criterion": "inclusion criteria",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Stage pT1N0 (tumor </= 20mm, negative node) or pT2N0 (tumor 21-50mm, node negative) or pT1N0i+ (tumor </=20mm and isolated tumor cells in node[s]) or pT2N0i+ (tumor 21-50mm and isolated tumor cells in node[s]) (see Appendix 2). Tumor size must be sufficient for Prosigna® testing. pNX (nodal status unknown) stage is not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Stage pT1N0 (tumor </= 20mm, negative node)",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "pT1N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage pT2N0 (tumor 21-50mm, node negative)",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "pT2N0"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage pT1N0i+ (tumor </=20mm and isolated tumor cells in node[s])",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "pT1N0i+"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage pT2N0i+ (tumor 21-50mm and isolated tumor cells in node[s])",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "pT2N0i+"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor size must be sufficient for Prosigna® testing.",
                    "criterion": "tumor size",
                    "requirements": [
                        {
                            "requirement_type": "sufficiency for Prosigna® testing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pNX (nodal status unknown) stage is not eligible.",
                    "criterion": "nodal status",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "not pNX"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Inclusion criteria for study enrollment:",
            "criterions": []
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}