[96a5a0]: / output / allTrials / logical / NCT03703466_logical.json

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{
"info": {
"nct_id": "NCT03703466",
"official_title": "An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer",
"inclusion_criteria": "* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).\n* Have all of the following:\n\n * Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.\n * Prior treatment with chemotherapy for locally advanced or metastatic disease.\n * No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.\n* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.\n* Have adequate organ function.\n* Women of child-bearing potential must have a negative pregnancy test.\n* Are able to swallow tablets/capsules.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Are currently receiving treatment in a clinical study involving an investigational product.\n* Have a serious concomitant systemic disorder.\n* Have symptomatic central nervous system (CNS) malignancy or metastasis.\n* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.\n* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n* Have a history of any other cancer.\n* Had major surgery within 14 days prior to randomization.\n* Are breastfeeding.\n* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).",
"criterions": [
{
"exact_snippets": "diagnosis of HR+",
"criterion": "hormone receptor status",
"requirement": {
"requirement_type": "status",
"expected_value": "HR+"
}
},
{
"exact_snippets": "HER2-",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "HER2-"
}
},
{
"exact_snippets": "metastatic breast cancer (mBC)",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "metastatic breast cancer"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "diagnosis of HR+",
"criterion": "hormone receptor status",
"requirement": {
"requirement_type": "status",
"expected_value": "HR+"
}
},
{
"exact_snippets": "HER2-",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "HER2-"
}
},
{
"exact_snippets": "metastatic breast cancer (mBC)",
"criterion": "cancer type",
"requirement": {
"requirement_type": "type",
"expected_value": "metastatic breast cancer"
}
}
]
}
},
{
"identified_line": {
"line": "* Have all of the following:",
"criterions": [
{
"exact_snippets": "all of the following",
"criterion": "all of the following",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "all of the following",
"criterion": "all of the following",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.",
"criterions": [
{
"exact_snippets": "Recurrent",
"criterion": "cancer recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "locally advanced",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
},
{
"exact_snippets": "unresectable",
"criterion": "surgical resectability",
"requirement": {
"requirement_type": "resectability",
"expected_value": false
}
},
{
"exact_snippets": "mBC",
"criterion": "metastatic breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "disease progression following anti-estrogen therapy",
"criterion": "disease progression after anti-estrogen therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Recurrent",
"criterion": "cancer recurrence",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "disease progression following anti-estrogen therapy",
"criterion": "disease progression after anti-estrogen therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "locally advanced",
"criterion": "cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "locally advanced"
}
},
{
"exact_snippets": "disease progression following anti-estrogen therapy",
"criterion": "disease progression after anti-estrogen therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "unresectable",
"criterion": "surgical resectability",
"requirement": {
"requirement_type": "resectability",
"expected_value": false
}
},
{
"exact_snippets": "disease progression following anti-estrogen therapy",
"criterion": "disease progression after anti-estrogen therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "mBC",
"criterion": "metastatic breast cancer",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "disease progression following anti-estrogen therapy",
"criterion": "disease progression after anti-estrogen therapy",
"requirement": {
"requirement_type": "progression",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Prior treatment with chemotherapy for locally advanced or metastatic disease.",
"criterions": [
{
"exact_snippets": "Prior treatment with chemotherapy for locally advanced or metastatic disease.",
"criterion": "prior chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Prior treatment with chemotherapy for locally advanced or metastatic disease.",
"criterion": "prior chemotherapy treatment",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.",
"criterions": [
{
"exact_snippets": "No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.",
"criterion": "prior treatment with CDK 4 and 6 inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.",
"criterion": "prior treatment with CDK 4 and 6 inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "N/A"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.",
"criterions": [
{
"exact_snippets": "discontinued all previous treatments for cancer",
"criterion": "previous cancer treatments",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": true
}
},
{
"exact_snippets": "recovered from the acute effects of therapy",
"criterion": "recovery from acute effects of therapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "discontinued all previous treatments for cancer",
"criterion": "previous cancer treatments",
"requirement": {
"requirement_type": "discontinuation",
"expected_value": true
}
},
{
"exact_snippets": "recovered from the acute effects of therapy",
"criterion": "recovery from acute effects of therapy",
"requirement": {
"requirement_type": "recovery",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Have adequate organ function.",
"criterions": [
{
"exact_snippets": "adequate organ function",
"criterion": "organ function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "adequate organ function",
"criterion": "organ function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Women of child-bearing potential must have a negative pregnancy test.",
"criterions": [
{
"exact_snippets": "Women of child-bearing potential",
"criterion": "child-bearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Women of child-bearing potential",
"criterion": "child-bearing potential",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "negative pregnancy test",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "result",
"expected_value": "negative"
}
}
]
}
},
{
"identified_line": {
"line": "* Are able to swallow tablets/capsules.",
"criterions": [
{
"exact_snippets": "able to swallow tablets/capsules",
"criterion": "ability to swallow tablets/capsules",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "able to swallow tablets/capsules",
"criterion": "ability to swallow tablets/capsules",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
}
},
{
"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 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": [
{
"identified_line": {
"line": "* Are currently receiving treatment in a clinical study involving an investigational product.",
"criterions": [
{
"exact_snippets": "currently receiving treatment in a clinical study involving an investigational product",
"criterion": "treatment in a clinical study",
"requirement": {
"requirement_type": "involvement",
"expected_value": "investigational product"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "currently receiving treatment in a clinical study involving an investigational product",
"criterion": "treatment in a clinical study",
"requirement": {
"requirement_type": "involvement",
"expected_value": "investigational product"
}
}
}
},
{
"identified_line": {
"line": "* Have a serious concomitant systemic disorder.",
"criterions": [
{
"exact_snippets": "serious concomitant systemic disorder",
"criterion": "systemic disorder",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "serious concomitant systemic disorder",
"criterion": "systemic disorder",
"requirement": {
"requirement_type": "concomitance",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "serious concomitant systemic disorder",
"criterion": "systemic disorder",
"requirement": {
"requirement_type": "severity",
"expected_value": "serious"
}
},
{
"exact_snippets": "serious concomitant systemic disorder",
"criterion": "systemic disorder",
"requirement": {
"requirement_type": "concomitance",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Have symptomatic central nervous system (CNS) malignancy or metastasis.",
"criterions": [
{
"exact_snippets": "symptomatic central nervous system (CNS) malignancy",
"criterion": "central nervous system (CNS) malignancy",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
},
{
"exact_snippets": "symptomatic central nervous system (CNS) ... metastasis",
"criterion": "central nervous system (CNS) metastasis",
"requirement": {
"requirement_type": "symptomatic",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "symptomatic central nervous system (CNS) malignancy",
"criterion": "central nervous system (CNS) malignancy",
"requirement": {
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{
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{
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}
},
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"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}