{
"info": {
"nct_id": "NCT00532857",
"official_title": "Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab in Patients With HER2 Positive Operable Breast Cancer",
"inclusion_criteria": "* All patients must have histologically confirmed and newly diagnosed operable breast cancer\n* HER2 positive (all FISH +)\n* Axillary node positive (by PET or cytologically determine node by sonography) and/or tumor size > 5 cm -No prior hormonal, chemotherapy or radiotherapy is allowed.\n* No breast operation other than biopsy to make diagnosis is allowed.\n* Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)\n* Adequate hematopoietic function:\n\nAbsolute granulocyte count ³1500/mm3,\n\n* platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3\n* Adequate renal function: Serum creatinine £ 1.5 mg/dl\n* Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function:\n\n 1. normal or nonspecific EKG taken within 1 mo of enrollment\n 2. LVEF ³ 50% by MUGA or Echocardiogram taken within 1 mo of enrollment\n* Normal mental function to understand and sign the consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 20 Years\nMust have maximum age of 80 Years",
"exclusion_criteria": "* patients who received hormonal, chemotherapy or radiotherapy for breast cancer\n* patients who underwent surgery for breast cancer\n* patients with a history of uncompensated congestive heart failure\n* Patients with node-negative stage IIA (T2N0) breast cancer\n* Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* All patients must have histologically confirmed and newly diagnosed operable breast cancer",
"criterions": [
{
"exact_snippets": "histologically confirmed",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histological"
}
},
{
"exact_snippets": "newly diagnosed",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "operable breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "operability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "histologically confirmed",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "confirmation method",
"expected_value": "histological"
}
},
{
"exact_snippets": "newly diagnosed",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "diagnosis status",
"expected_value": "newly diagnosed"
}
},
{
"exact_snippets": "operable breast cancer",
"criterion": "breast cancer",
"requirement": {
"requirement_type": "operability",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* HER2 positive (all FISH +)",
"criterions": [
{
"exact_snippets": "HER2 positive (all FISH +)",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "HER2 positive (all FISH +)",
"criterion": "HER2 status",
"requirement": {
"requirement_type": "FISH",
"expected_value": "+"
}
}
]
},
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"exact_snippets": "HER2 positive (all FISH +)",
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}
},
{
"exact_snippets": "HER2 positive (all FISH +)",
"criterion": "HER2 status",
"requirement": {
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"expected_value": "+"
}
}
]
}
},
{
"identified_line": {
"line": "* No breast operation other than biopsy to make diagnosis is allowed.",
"criterions": [
{
"exact_snippets": "No breast operation other than biopsy to make diagnosis is allowed.",
"criterion": "breast operation",
"requirement": {
"requirement_type": "type",
"expected_value": "biopsy"
}
}
]
},
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"and_criteria": [
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"exact_snippets": "No breast operation other than biopsy to make diagnosis is allowed.",
"criterion": "breast operation",
"requirement": {
"requirement_type": "type",
"expected_value": "biopsy"
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate hematopoietic function:",
"criterions": [
{
"exact_snippets": "Adequate hematopoietic function",
"criterion": "hematopoietic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate hematopoietic function",
"criterion": "hematopoietic function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Absolute granulocyte count ³1500/mm3,",
"criterions": [
{
"exact_snippets": "Absolute granulocyte count ³1500/mm3",
"criterion": "absolute granulocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Absolute granulocyte count ³1500/mm3",
"criterion": "absolute granulocyte count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1500,
"unit": "mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3",
"criterions": [
{
"exact_snippets": "platelet ³100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Hemoglobin ³ 10 g/mm3",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/mm3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "platelet ³100,000/mm3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm3"
}
}
},
{
"exact_snippets": "Hemoglobin ³ 10 g/mm3",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 10,
"unit": "g/mm3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Adequate renal function: Serum creatinine £ 1.5 mg/dl",
"criterions": [
{
"exact_snippets": "Adequate renal function: Serum creatinine £ 1.5 mg/dl",
"criterion": "renal function",
"requirement": {
"requirement_type": "serum creatinine level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate renal function: Serum creatinine £ 1.5 mg/dl",
"criterion": "renal function",
"requirement": {
"requirement_type": "serum creatinine level",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "1. normal or nonspecific EKG taken within 1 mo of enrollment",
"criterions": [
{
"exact_snippets": "normal or nonspecific EKG",
"criterion": "EKG result",
"requirement": {
"requirement_type": "result type",
"expected_value": [
"normal",
"nonspecific"
]
}
},
{
"exact_snippets": "EKG taken within 1 mo of enrollment",
"criterion": "EKG timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "mo"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "normal or nonspecific EKG",
"criterion": "EKG result",
"requirement": {
"requirement_type": "result type",
"expected_value": [
"normal",
"nonspecific"
]
}
},
{
"exact_snippets": "EKG taken within 1 mo of enrollment",
"criterion": "EKG timing",
"requirement": {
"requirement_type": "timing",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "mo"
}
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Axillary node positive (by PET or cytologically determine node by sonography) and/or tumor size > 5 cm -No prior hormonal, chemotherapy or radiotherapy is allowed.",
"criterions": [
{
"exact_snippets": "Axillary node positive (by PET or cytologically determine node by sonography)",
"criterion": "axillary node",
"requirement": {
"requirement_type": "status",
"expected_value": "positive"
}
},
{
"exact_snippets": "tumor size > 5 cm",
"criterion": "tumor size",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">",
"value": 5,
"unit": "cm"
}
}
},
{
"exact_snippets": "No prior hormonal, chemotherapy or radiotherapy is allowed",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "types",
"expected_value": [
"hormonal",
"chemotherapy",
"radiotherapy"
]
}
},
{
"exact_snippets": "No prior hormonal, chemotherapy or radiotherapy is allowed",
"criterion": "prior treatment",
"requirement": {
"requirement_type": "status",
"expected_value": false
}
}
]
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"or_criteria": [
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"and_criteria": [
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"requirement_type": "status",
"expected_value": "positive"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "tumor size > 5 cm",
"criterion": "tumor size",
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"expected_value": {
"operator": ">",
"value": 5,
"unit": "cm"
}
}
}
]
}
]
},
{
"and_criteria": [
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"exact_snippets": "No prior hormonal, chemotherapy or radiotherapy is allowed",
"criterion": "prior treatment",
"requirement": {
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"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ 2 times normal, Alkaline phosphatase: £ 2 times normal-Adequate cardiac function:",
"criterions": [
{
"exact_snippets": "Adequate hepatic function: total bilirubin: £ 1.5 mg/dl",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "adequacy",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Adequate hepatic function: ... AST/ALT: £ 2 times normal",
"criterion": "AST/ALT",
"requirement": {
"requirement_type": "adequacy",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times normal"
}
}
},
{
"exact_snippets": "Adequate hepatic function: ... Alkaline phosphatase: £ 2 times normal",
"criterion": "Alkaline phosphatase",
"requirement": {
"requirement_type": "adequacy",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "times normal"
}
}
},
{
"exact_snippets": "Adequate cardiac function",
"criterion": "cardiac function",
"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Adequate hepatic function: total bilirubin: £ 1.5 mg/dl",
"criterion": "total bilirubin",
"requirement": {
"requirement_type": "adequacy",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Adequate hepatic function: ... AST/ALT: £ 2 times normal",
"criterion": "AST/ALT",
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"operator": "<=",
"value": 2,
"unit": "times normal"
}
}
},
{
"exact_snippets": "Adequate hepatic function: ... Alkaline phosphatase: £ 2 times normal",
"criterion": "Alkaline phosphatase",
"requirement": {
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"operator": "<=",
"value": 2,
"unit": "times normal"
}
}
}
]
}
]
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "LVEF",
"requirement": {
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"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "MUGA or Echocardiogram",
"criterion": "method of LVEF measurement",
"requirement": {
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"expected_value": [
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"Echocardiogram"
]
}
},
{
"exact_snippets": "taken within 1 mo of enrollment",
"criterion": "timing of LVEF measurement",
"requirement": {
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}
}
]
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"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "LVEF \u00179 50%",
"criterion": "LVEF",
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"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
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"Echocardiogram"
]
}
}
]
},
{
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"requirement": {
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}
}
]
}
},
{
"identified_line": {
"line": "* Normal mental function to understand and sign the consent",
"criterions": [
{
"exact_snippets": "Normal mental function",
"criterion": "mental function",
"requirement": {
"requirement_type": "status",
"expected_value": "normal"
}
},
{
"exact_snippets": "understand and sign the consent",
"criterion": "ability to understand and sign consent",
"requirement": {
"requirement_type": "ability",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
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},
{
"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": {
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Must be FEMALE",
"criterions": [
{
"exact_snippets": "Must be FEMALE",
"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
}
]
},
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}
}
},
{
"identified_line": {
"line": "Must have minimum age of 20 Years",
"criterions": [
{
"exact_snippets": "minimum age of 20 Years",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 20,
"unit": "Years"
}
}
}
]
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},
{
"identified_line": {
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{
"exact_snippets": "maximum age of 80 Years",
"criterion": "age",
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"value": 80,
"unit": "Years"
}
}
}
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{
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"line": "* Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)",
"criterions": [
{
"exact_snippets": "Age: 18-years and older",
"criterion": "age",
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"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
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{
"exact_snippets": "not pregnant",
"criterion": "pregnancy status",
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"expected_value": false
}
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{
"exact_snippets": "premenopausal women",
"criterion": "menopausal status",
"requirement": {
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"expected_value": "premenopausal"
}
},
{
"exact_snippets": "postmenopausal women",
"criterion": "menopausal status",
"requirement": {
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"expected_value": "postmenopausal"
}
},
{
"exact_snippets": "good performance status (ECOG 0-1)",
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"requirement": {
"requirement_type": "ECOG score",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 0,
"unit": "ECOG"
},
{
"operator": "<=",
"value": 1,
"unit": "ECOG"
}
]
}
}
}
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],
"failed_exclusion": [
{
"identified_line": {
"line": "* patients who received hormonal, chemotherapy or radiotherapy for breast cancer",
"criterions": [
{
"exact_snippets": "patients who received hormonal ... for breast cancer",
"criterion": "hormonal therapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "patients who received ... chemotherapy ... for breast cancer",
"criterion": "chemotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
},
{
"exact_snippets": "patients who received ... radiotherapy for breast cancer",
"criterion": "radiotherapy",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
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"logical_structure": {
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"requirement": {
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}
},
{
"identified_line": {
"line": "* patients who underwent surgery for breast cancer",
"criterions": [
{
"exact_snippets": "underwent surgery for breast cancer",
"criterion": "surgery for breast cancer",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* patients with a history of uncompensated congestive heart failure",
"criterions": [
{
"exact_snippets": "history of uncompensated congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
"requirement_type": "compensation status",
"expected_value": "uncompensated"
}
},
{
"exact_snippets": "history of uncompensated congestive heart failure",
"criterion": "congestive heart failure",
"requirement": {
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"expected_value": true
}
}
]
},
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients with node-negative stage IIA (T2N0) breast cancer",
"criterions": [
{
"exact_snippets": "node-negative",
"criterion": "lymph node involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "stage IIA (T2N0) breast cancer",
"criterion": "breast cancer stage",
"requirement": {
"requirement_type": "stage",
"expected_value": "IIA (T2N0)"
}
}
]
},
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer",
"criterions": [
{
"exact_snippets": "history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer",
"criterion": "history of cancer",
"requirement": {
"requirement_type": "exclusion",
"expected_value": [
"in situ uterine cervix cancer",
"nonmelanotic skin cancer"
]
}
}
]
},
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"criterion": "failed",
"requirement": {
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}
}
}
],
"failed_miscellaneous": []
}