{
"info": {
"nct_id": "NCT02391194",
"official_title": "A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery",
"inclusion_criteria": "* Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast\n* Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n* Adequate renal function\n* Lab values (hematology and chemistry) within institution's normal laboratory limits\n* Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure\n* If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)\n* If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits\n* Subject has the ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Recurrent ipsilateral breast cancer\n* Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.\n* Open surgery in the ipsilateral breast within 1 year of AVB-620 administration\n* History of radiation therapy to ipsilateral breast\n* Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration\n* Diagnosis of autoimmune disorders\n* History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded\n* History of renal disease or current evidence of renal disease\n* Current diagnosis of any other active or clinically significant non-breast cancer\n* Systemic investigational drug of any kind within 6 weeks of AVB-620 administration\n* Pregnant or breast feeding",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast",
"criterions": [
{
"exact_snippets": "Ductal carcinoma in situ (DCIS)",
"criterion": "ductal carcinoma in situ",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Stage I-III, primary invasive carcinoma of the breast",
"criterion": "primary invasive carcinoma of the breast",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "Stage"
},
{
"operator": "<=",
"value": 3,
"unit": "Stage"
}
]
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Ductal carcinoma in situ (DCIS)",
"criterion": "ductal carcinoma in situ",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Stage I-III, primary invasive carcinoma of the breast",
"criterion": "primary invasive carcinoma of the breast",
"requirement": {
"requirement_type": "stage",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "Stage"
},
{
"operator": "<=",
"value": 3,
"unit": "Stage"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0-2",
"criterion": "ECOG performance status",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "N/A"
},
{
"operator": "<=",
"value": 2,
"unit": "N/A"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate renal function",
"criterions": [
{
"exact_snippets": "Adequate renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate renal function",
"criterion": "renal function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Lab values (hematology and chemistry) within institution's normal laboratory limits",
"criterions": [
{
"exact_snippets": "Lab values (hematology and chemistry) within institution's normal laboratory limits",
"criterion": "hematology lab values",
"requirement": {
"requirement_type": "range",
"expected_value": "within institution's normal laboratory limits"
}
},
{
"exact_snippets": "Lab values (hematology and chemistry) within institution's normal laboratory limits",
"criterion": "chemistry lab values",
"requirement": {
"requirement_type": "range",
"expected_value": "within institution's normal laboratory limits"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Lab values (hematology and chemistry) within institution's normal laboratory limits",
"criterion": "hematology lab values",
"requirement": {
"requirement_type": "range",
"expected_value": "within institution's normal laboratory limits"
}
},
{
"exact_snippets": "Lab values (hematology and chemistry) within institution's normal laboratory limits",
"criterion": "chemistry lab values",
"requirement": {
"requirement_type": "range",
"expected_value": "within institution's normal laboratory limits"
}
}
]
}
},
{
"identified_line": {
"line": "* Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure",
"criterions": [
{
"exact_snippets": "Willing to remain on-site for approximately 24 hours after administration of AVB-620",
"criterion": "willingness to remain on-site",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 24,
"unit": "hours"
}
}
},
{
"exact_snippets": "if required, stay overnight after the surgical procedure",
"criterion": "willingness to stay overnight",
"requirement": {
"requirement_type": "condition",
"expected_value": "if required"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Willing to remain on-site for approximately 24 hours after administration of AVB-620",
"criterion": "willingness to remain on-site",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": "=",
"value": 24,
"unit": "hours"
}
}
},
{
"exact_snippets": "if required, stay overnight after the surgical procedure",
"criterion": "willingness to stay overnight",
"requirement": {
"requirement_type": "condition",
"expected_value": "if required"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)",
"criterions": [
{
"exact_snippets": "If the subject received neoadjuvant therapy",
"criterion": "neoadjuvant therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
{
"exact_snippets": "residual tumor is present",
"criterion": "residual tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "If the subject received neoadjuvant therapy",
"criterion": "neoadjuvant therapy",
"requirement": {
"requirement_type": "receipt",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "residual tumor is present",
"criterion": "residual tumor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits",
"criterions": [
{
"exact_snippets": "If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "range",
"expected_value": "within institution's normal limits"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits",
"criterion": "prior anthracycline therapy",
"requirement": {
"requirement_type": "received",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits",
"criterion": "left ventricular ejection fraction (LVEF)",
"requirement": {
"requirement_type": "range",
"expected_value": "within institution's normal limits"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Subject has the ability to understand and the willingness to sign a written informed consent document",
"criterions": [
{
"exact_snippets": "Subject has the ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Subject has the ability to understand",
"criterion": "cognitive ability",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "willingness to sign a written informed consent document",
"criterion": "willingness to consent",
"requirement": {
"requirement_type": "presence",
"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 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": {
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"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": [
{
"identified_line": {
"line": "* Recurrent ipsilateral breast cancer",
"criterions": [
{
"exact_snippets": "Recurrent ipsilateral breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "Recurrent ipsilateral breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "laterality",
"expected_value": "ipsilateral"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Recurrent ipsilateral breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "Recurrent ipsilateral breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "laterality",
"expected_value": "ipsilateral"
}
}
]
}
},
{
"identified_line": {
"line": "* Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.",
"criterions": [
{
"exact_snippets": "Prior neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 4 weeks before the planned surgery"
}
},
{
"exact_snippets": "biologic therapy",
"criterion": "biologic therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 4 weeks before the planned surgery"
}
},
{
"exact_snippets": "current clinically or biopsy-proven node positive breast cancer",
"criterion": "node positive breast cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": [
"clinically proven",
"biopsy-proven"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Prior neoadjuvant chemotherapy",
"criterion": "neoadjuvant chemotherapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 4 weeks before the planned surgery"
}
},
{
"exact_snippets": "current clinically or biopsy-proven node positive breast cancer",
"criterion": "node positive breast cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": [
"clinically proven",
"biopsy-proven"
]
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "biologic therapy",
"criterion": "biologic therapy",
"requirement": {
"requirement_type": "timing",
"expected_value": "within 4 weeks before the planned surgery"
}
},
{
"exact_snippets": "current clinically or biopsy-proven node positive breast cancer",
"criterion": "node positive breast cancer",
"requirement": {
"requirement_type": "confirmation",
"expected_value": [
"clinically proven",
"biopsy-proven"
]
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Open surgery in the ipsilateral breast within 1 year of AVB-620 administration",
"criterions": [
{
"exact_snippets": "Open surgery in the ipsilateral breast",
"criterion": "open surgery in the ipsilateral breast",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Open surgery in the ipsilateral breast",
"criterion": "open surgery in the ipsilateral breast",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
}
}
},
{
"identified_line": {
"line": "* History of radiation therapy to ipsilateral breast",
"criterions": [
{
"exact_snippets": "History of radiation therapy to ipsilateral breast",
"criterion": "radiation therapy to ipsilateral breast",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "History of radiation therapy to ipsilateral breast",
"criterion": "radiation therapy to ipsilateral breast",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration",
"criterions": [
{
"exact_snippets": "Abnormal cardiac rhythm not controlled with medication",
"criterion": "abnormal cardiac rhythm",
"requirement": {
"requirement_type": "control with medication",
"expected_value": false
}
},
{
"exact_snippets": "history of stroke",
"criterion": "history of stroke",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "coronary events",
"criterion": "coronary events",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "heart failure within 1 year of AVB-620 administration",
"criterion": "heart failure",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Abnormal cardiac rhythm not controlled with medication",
"criterion": "abnormal cardiac rhythm",
"requirement": {
"requirement_type": "control with medication",
"expected_value": false
}
},
{
"or_criteria": [
{
"exact_snippets": "history of stroke",
"criterion": "history of stroke",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "coronary events",
"criterion": "coronary events",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "heart failure within 1 year of AVB-620 administration",
"criterion": "heart failure",
"requirement": {
"requirement_type": "time since event",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "year"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis of autoimmune disorders",
"criterions": [
{
"exact_snippets": "Diagnosis of autoimmune disorders",
"criterion": "autoimmune disorders",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Diagnosis of autoimmune disorders",
"criterion": "autoimmune disorders",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded",
"criterions": [
{
"exact_snippets": "History of drug-related anaphylactic reactions or allergic reactions",
"criterion": "drug-related anaphylactic reactions or allergic reactions",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "active diagnosis of uncontrolled airway hyperactivity",
"criterion": "uncontrolled airway hyperactivity",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "active"
}
},
{
"exact_snippets": "uncontrolled asthma",
"criterion": "asthma",
"requirement": {
"requirement_type": "control",
"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "asthma requiring oral corticosteroids",
"criterion": "asthma",
"requirement": {
"requirement_type": "treatment",
"expected_value": "oral corticosteroids"
}
}
]
},
"logical_structure": {
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{
"exact_snippets": "History of drug-related anaphylactic reactions or allergic reactions",
"criterion": "drug-related anaphylactic reactions or allergic reactions",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "active diagnosis of uncontrolled airway hyperactivity",
"criterion": "uncontrolled airway hyperactivity",
"requirement": {
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"expected_value": "active"
}
},
{
"exact_snippets": "uncontrolled asthma",
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"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "asthma requiring oral corticosteroids",
"criterion": "asthma",
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"expected_value": "oral corticosteroids"
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "uncontrolled asthma",
"criterion": "asthma",
"requirement": {
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"expected_value": "uncontrolled"
}
},
{
"exact_snippets": "asthma requiring oral corticosteroids",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* History of renal disease or current evidence of renal disease",
"criterions": [
{
"exact_snippets": "History of renal disease",
"criterion": "renal disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "current evidence of renal disease",
"criterion": "renal disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "History of renal disease",
"criterion": "renal disease",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "current evidence of renal disease",
"criterion": "renal disease",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Current diagnosis of any other active or clinically significant non-breast cancer",
"criterions": [
{
"exact_snippets": "Current diagnosis of any other active or clinically significant non-breast cancer",
"criterion": "non-breast cancer",
"requirement": {
"requirement_type": "diagnosis",
"expected_value": "active or clinically significant"
}
}
]
},
"logical_structure": {
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"exact_snippets": "Current diagnosis of any other active or clinically significant non-breast cancer",
"criterion": "non-breast cancer",
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"requirement_type": "diagnosis",
"expected_value": "active or clinically significant"
}
}
}
},
{
"identified_line": {
"line": "* Systemic investigational drug of any kind within 6 weeks of AVB-620 administration",
"criterions": [
{
"exact_snippets": "Systemic investigational drug of any kind within 6 weeks of AVB-620 administration",
"criterion": "systemic investigational drug",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Systemic investigational drug of any kind within 6 weeks of AVB-620 administration",
"criterion": "systemic investigational drug",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": ">=",
"value": 6,
"unit": "weeks"
}
}
}
}
},
{
"identified_line": {
"line": "* Pregnant or breast feeding",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast feeding",
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}
}
]
},
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{
"exact_snippets": "Pregnant",
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}
},
{
"exact_snippets": "breast feeding",
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}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.",
"criterions": [
{
"exact_snippets": "Primary surgical treatment is planned to be a mastectomy or lumpectomy.",
"criterion": "primary surgical treatment",
"requirement": {
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"lumpectomy"
]
}
},
{
"exact_snippets": "Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.",
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}
},
{
"exact_snippets": "Primary surgical treatment is planned to be a mastectomy or lumpectomy.",
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{
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{
"exact_snippets": "Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.",
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"failed_miscellaneous": []
}