{
"info": {
"nct_id": "NCT06672120",
"official_title": "Exercise in Regional Breast Cancer With Neoadjuvant Anthracycline- Based Chemotherapy and Immunotherapy With Checkpoint-Inhibition",
"inclusion_criteria": "* Female patients with newly diagnosed, local triple-negative breast cancer (stage I-III) ≥ 18 to 50 years of age scheduled for immunochemotherapy with pembrolizumab and anthracycline-based chemotherapy\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 50 Years",
"exclusion_criteria": "* Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease, signs of acute heart failure, haemodynamically relevant arrhythmias)\n* Orthopaedic disability to exercise",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Female patients with newly diagnosed, local triple-negative breast cancer (stage I-III) ≥ 18 to 50 years of age scheduled for immunochemotherapy with pembrolizumab and anthracycline-based chemotherapy",
"criterions": [
{
"exact_snippets": "Female patients",
"criterion": "gender",
"requirements": [
{
"requirement_type": "value",
"expected_value": "female"
}
]
},
{
"exact_snippets": "newly diagnosed, local triple-negative breast cancer",
"criterion": "breast cancer type",
"requirements": [
{
"requirement_type": "diagnosis",
"expected_value": "newly diagnosed"
},
{
"requirement_type": "locality",
"expected_value": "local"
},
{
"requirement_type": "subtype",
"expected_value": "triple-negative"
}
]
},
{
"exact_snippets": "stage I-III",
"criterion": "cancer stage",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "stage"
},
{
"operator": "<=",
"value": 3,
"unit": "stage"
}
]
}
}
]
},
{
"exact_snippets": "≥ 18 to 50 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 50,
"unit": "years"
}
]
}
}
]
},
{
"exact_snippets": "scheduled for immunochemotherapy with pembrolizumab and anthracycline-based chemotherapy",
"criterion": "treatment plan",
"requirements": [
{
"requirement_type": "scheduled",
"expected_value": [
"immunochemotherapy with pembrolizumab",
"anthracycline-based chemotherapy"
]
}
]
}
]
},
{
"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 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
},
{
"line": "Must have maximum age of 50 Years",
"criterions": [
{
"exact_snippets": "maximum age of 50 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 50,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease, signs of acute heart failure, haemodynamically relevant arrhythmias)",
"criterions": [
{
"exact_snippets": "Unstable cardiac condition (clinical suspicion of progress or unstable coronary artery disease",
"criterion": "unstable coronary artery disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Unstable cardiac condition ... signs of acute heart failure",
"criterion": "acute heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "Unstable cardiac condition ... haemodynamically relevant arrhythmias",
"criterion": "haemodynamically relevant arrhythmias",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Orthopaedic disability to exercise",
"criterions": [
{
"exact_snippets": "Orthopaedic disability to exercise",
"criterion": "orthopaedic disability",
"requirements": [
{
"requirement_type": "impact on exercise",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}