{
    "info": {
        "nct_id": "NCT01705691",
        "official_title": "A Phase II Randomized Clinical Trial Evaluating Neoadjuvant Chemotherapy Regimens With Weekly Paclitaxel or Eribulin Followed by Doxorubicin and Cyclophosphamide in Women With Locally Advanced HER2-Negative Breast Cancer",
        "inclusion_criteria": "* Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)\n* Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.\n* The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.\n* Patients must be female.\n* Patients must be > 18 years old.\n* The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.\n* The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.\n* Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then Progesterone Receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)\n* Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1, cT3 and cN0 or cN1, Any cT and cN2 or cN3, cT4\n* The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.\n* At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: Absolute Neutrophil Count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.\n* The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to Upper Limit of Normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 1.5 x ULN for the lab; and Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.\n* Patients with alkaline phosphatase > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements in the criteria below for unexplained skeletal pain are met.\n* Patients with either unexplained skeletal pain or alkaline phosphatase that is > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.\n* Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.\n* Serum potassium and serum magnesium performed within 4 weeks prior to randomization must be Within Normal Limits (WNL).\n* The Left Ventricular Ejection Fraction (LVEF) assessment by 2-D echocardiogram or Multigated acquisition (MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's Lower Limit of Normal (LLN).\n* ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by in situ hybridization (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.\n* Fine Needle Aspiration (FNA) alone to diagnose the primary breast cancer.\n* Excisional biopsy or lumpectomy performed prior to randomization.\n* Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy Sentinal Node (SN) biopsy for patients with clinically negative axillary nodes.)\n* Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging is mandatory for all patients within 90 days prior to randomization. Other imaging [if required] must have been performed within 4 weeks prior to randomization.)\n* History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral Ductal Carcinoma in Situ (DCIS) treated with Radiation Therapy (RT). (Patients with a history of Lobular Carcinoma in Situ (LCIS), contralateral DCIS [regardless of RT], or contralateral invasive breast cancer are eligible.)\n* History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.\n* Known metastatic disease from any malignancy (solid tumor or hematologic).\n* Previous therapy with anthracyclines, taxanes, cyclophosphamide, or eribulin for any malignancy.\n* Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.\n* Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)\n* Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.\n* Requirement for chronic use of any drugs known to prolong the QT interval, including Na+ and K+ channel blockers. (Patients are eligible if these medications and/or substances can be discontinued prior to the first dose of eribulin and will not need to be resumed until after the last dose of eribulin.)\n* Active hepatitis B or hepatitis C with abnormal liver function tests.\n* Intrinsic lung disease resulting in dyspnea.\n* Active infection; or chronic infection requiring chronic suppressive antibiotics.\n* Persistent greater than or equal to grade 2 diarrhea regardless of etiology.\n* Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.\n* Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.\n* Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).\n* Uncontrolled hypertension defined as a systolic BP > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)\n* Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of Left Ventricular (LV) function; history of documented Congestive Heart Failure (CHF) documented cardiomyopathy; and congenital long QT syndrome.\n* Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.\n* Pregnancy or lactation at the time of randomization.\n* Any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.\n* Use of any investigation agent within 4 weeks prior to randomization.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients should have a life expectancy of at least 10 years, excluding their diagnosis of breast cancer. (Comorbid conditions should be taken into consideration, but not the diagnosis of breast cancer.)",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 10 years",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy and for at least 6 months after the last dose of study therapy.",
            "criterions": [
                {
                    "exact_snippets": "Patients of reproductive potential",
                    "criterion": "reproductive potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must agree to use an effective non-hormonal method of contraception",
                    "criterion": "contraception method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "effective non-hormonal"
                        }
                    ]
                },
                {
                    "exact_snippets": "during therapy and for at least 6 months after the last dose of study therapy",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during therapy and for at least 6 months after the last dose of study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines.",
            "criterions": [
                {
                    "exact_snippets": "The patient must have consented to participate",
                    "criterion": "consent to participate",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form",
                    "criterion": "IRB-approved consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed and dated",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "that conforms to federal and institutional guidelines",
                    "criterion": "consent form conformity",
                    "requirements": [
                        {
                            "requirement_type": "conformity",
                            "expected_value": [
                                "federal guidelines",
                                "institutional guidelines"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be female.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be female.",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be > 18 years old.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be > 18 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or by limited incisional biopsy.",
            "criterions": [
                {
                    "exact_snippets": "diagnosis of invasive adenocarcinoma of the breast",
                    "criterion": "invasive adenocarcinoma of the breast",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have been made by core needle biopsy or by limited incisional biopsy",
                    "criterion": "biopsy method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "core needle biopsy",
                                "limited incisional biopsy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then Progesterone Receptor (PgR) analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.)",
            "criterions": [
                {
                    "exact_snippets": "ER analysis performed on the primary tumor",
                    "criterion": "ER analysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ER analysis is negative ... Progesterone Receptor (PgR) analysis must also be performed",
                    "criterion": "PgR analysis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC: cT2 and cN1, cT3 and cN0 or cN1, Any cT and cN2 or cN3, cT4",
            "criterions": [
                {
                    "exact_snippets": "Clinical staging, based on the assessment by physical exam, must be American Joint Committee on Cancer (AJCC) stage IIB, IIIA, IIIB, or IIIC",
                    "criterion": "AJCC stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "IIB",
                                "IIIA",
                                "IIIB",
                                "IIIC"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cT2 and cN1",
                    "criterion": "cT and cN",
                    "requirements": [
                        {
                            "requirement_type": "cT",
                            "expected_value": "cT2"
                        },
                        {
                            "requirement_type": "cN",
                            "expected_value": "cN1"
                        }
                    ]
                },
                {
                    "exact_snippets": "cT3 and cN0 or cN1",
                    "criterion": "cT and cN",
                    "requirements": [
                        {
                            "requirement_type": "cT",
                            "expected_value": "cT3"
                        },
                        {
                            "requirement_type": "cN",
                            "expected_value": [
                                "cN0",
                                "cN1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Any cT and cN2 or cN3",
                    "criterion": "cT and cN",
                    "requirements": [
                        {
                            "requirement_type": "cT",
                            "expected_value": "Any cT"
                        },
                        {
                            "requirement_type": "cN",
                            "expected_value": [
                                "cN2",
                                "cN3"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "cT4",
                    "criterion": "cT",
                    "requirements": [
                        {
                            "requirement_type": "cT",
                            "expected_value": "cT4"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The patient must have a mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required.",
            "criterions": [
                {
                    "exact_snippets": "mass in the breast or axilla",
                    "criterion": "mass location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": [
                                "breast",
                                "axilla"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "mass in the breast or axilla measuring greater than or equal to 2.0 cm by physical exam",
                    "criterion": "mass size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the patient has inflammatory breast cancer",
                    "criterion": "inflammatory breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required",
                    "criterion": "measurable disease by physical exam",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: Absolute Neutrophil Count (ANC) must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.",
            "criterions": [
                {
                    "exact_snippets": "Absolute Neutrophil Count (ANC) must be greater than or equal to 1200/mm3",
                    "criterion": "Absolute Neutrophil Count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1200,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelet count must be greater than or equal to 100,000/mm3",
                    "criterion": "Platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Hemoglobin must be greater than or equal to 10 g/dL",
                    "criterion": "Hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The following criteria for evidence of adequate hepatic function performed within 4 weeks prior to randomization must be met: total bilirubin must be less than or equal to Upper Limit of Normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 1.5 x ULN for the lab; and Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab.",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin must be less than or equal to Upper Limit of Normal (ULN) for the lab",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin",
                    "criterion": "bilirubin elevation due to Gilbert's disease or similar syndrome",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 1,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase must be less than or equal to 1.5 x ULN for the lab",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab",
                    "criterion": "Aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) must be less than or equal to 1.5 x ULN for the lab",
                    "criterion": "Alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with alkaline phosphatase > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease and the requirements in the criteria below for unexplained skeletal pain are met.",
            "criterions": [
                {
                    "exact_snippets": "alkaline phosphatase > ULN but less than or equal to 1.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 1,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "liver imaging (CT, MRI, PET, or PET-CT scan) performed within 4 weeks prior to randomization does not demonstrate metastatic disease",
                    "criterion": "liver imaging",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks prior to randomization"
                        },
                        {
                            "requirement_type": "result",
                            "expected_value": "does not demonstrate metastatic disease"
                        }
                    ]
                },
                {
                    "exact_snippets": "requirements in the criteria below for unexplained skeletal pain are met",
                    "criterion": "unexplained skeletal pain",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "requirements in the criteria below are met"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with either unexplained skeletal pain or alkaline phosphatase that is > ULN but less than or equal to 1.5 x ULN are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization does not demonstrate metastatic disease. Patients with suspicious findings on bone scan or PET scan are eligible if suspicious findings are determined to be benign by x-ray, MRI, or biopsy.",
            "criterions": [
                {
                    "exact_snippets": "unexplained skeletal pain",
                    "criterion": "skeletal pain",
                    "requirements": [
                        {
                            "requirement_type": "cause",
                            "expected_value": "unexplained"
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase that is > ULN but less than or equal to 1.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">",
                                        "value": 1,
                                        "unit": "ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bone scan, PET-CT scan, or PET scan performed within 4 weeks prior to randomization",
                    "criterion": "bone scan, PET-CT scan, or PET scan",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "bone scan, PET-CT scan, or PET scan ... does not demonstrate metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "suspicious findings on bone scan or PET scan ... determined to be benign by x-ray, MRI, or biopsy",
                    "criterion": "suspicious findings",
                    "requirements": [
                        {
                            "requirement_type": "determination",
                            "expected_value": "benign"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine performed within 4 weeks prior to randomization must be less than or equal to 1.5 x ULN for the lab.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine ... must be less than or equal to 1.5 x ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The Left Ventricular Ejection Fraction (LVEF) assessment by 2-D echocardiogram or Multigated acquisition (MUGA) scan performed within 90 days prior to randomization must be greater than or equal to 50% regardless of the facility's Lower Limit of Normal (LLN).",
            "criterions": [
                {
                    "exact_snippets": "Left Ventricular Ejection Fraction (LVEF) assessment ... must be greater than or equal to 50%",
                    "criterion": "Left Ventricular Ejection Fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "assessment method",
                            "expected_value": [
                                "2-D echocardiogram",
                                "Multigated acquisition (MUGA) scan"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 90 days prior to randomization"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds.",
            "criterions": [
                {
                    "exact_snippets": "ECG performed within 4 weeks before study entry",
                    "criterion": "ECG timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 4 weeks before study entry"
                        }
                    ]
                },
                {
                    "exact_snippets": "ECG ... must demonstrate a QTc interval that is less than or equal to 0.47 seconds",
                    "criterion": "QTc interval",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 0.47,
                                "unit": "seconds"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by in situ hybridization (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy.",
            "criterions": [
                {
                    "exact_snippets": "Tumor that has been determined to be HER2-positive by immunohistochemistry (3+)",
                    "criterion": "HER2 status by immunohistochemistry",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "3+"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor that has been determined to be HER2-positive ... by in situ hybridization (positive for gene amplification)",
                    "criterion": "HER2 status by in situ hybridization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive for gene amplification"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumor ... has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy",
                    "criterion": "HER2-equivocal status with treatment plan",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "HER2-equivocal"
                        },
                        {
                            "requirement_type": "treatment plan",
                            "expected_value": "trastuzumab or other targeted therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fine Needle Aspiration (FNA) alone to diagnose the primary breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Fine Needle Aspiration (FNA) alone to diagnose the primary breast cancer.",
                    "criterion": "diagnostic method for primary breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "Fine Needle Aspiration (FNA)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Excisional biopsy or lumpectomy performed prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Excisional biopsy or lumpectomy performed prior to randomization.",
                    "criterion": "excisional biopsy or lumpectomy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Surgical axillary staging procedure prior to randomization. (Procedures that are permitted prior to study entry include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy Sentinal Node (SN) biopsy for patients with clinically negative axillary nodes.)",
            "criterions": [
                {
                    "exact_snippets": "Surgical axillary staging procedure prior to randomization.",
                    "criterion": "surgical axillary staging procedure",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to randomization"
                        }
                    ]
                },
                {
                    "exact_snippets": "FNA or core biopsy of an axillary node for any patient",
                    "criterion": "FNA or core biopsy of an axillary node",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-neoadjuvant therapy Sentinal Node (SN) biopsy for patients with clinically negative axillary nodes",
                    "criterion": "Sentinal Node (SN) biopsy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "pre-neoadjuvant therapy"
                        },
                        {
                            "requirement_type": "clinical status",
                            "expected_value": "clinically negative axillary nodes"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Definitive clinical or radiologic evidence of metastatic disease. (Note: Chest imaging is mandatory for all patients within 90 days prior to randomization. Other imaging [if required] must have been performed within 4 weeks prior to randomization.)",
            "criterions": [
                {
                    "exact_snippets": "Definitive clinical or radiologic evidence of metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": [
                                "clinical",
                                "radiologic"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Chest imaging is mandatory for all patients within 90 days prior to randomization",
                    "criterion": "chest imaging",
                    "requirements": [
                        {
                            "requirement_type": "mandatory",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Other imaging [if required] must have been performed within 4 weeks prior to randomization",
                    "criterion": "other imaging",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral Ductal Carcinoma in Situ (DCIS) treated with Radiation Therapy (RT). (Patients with a history of Lobular Carcinoma in Situ (LCIS), contralateral DCIS [regardless of RT], or contralateral invasive breast cancer are eligible.)",
            "criterions": [
                {
                    "exact_snippets": "History of ipsilateral invasive breast cancer",
                    "criterion": "ipsilateral invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ipsilateral Ductal Carcinoma in Situ (DCIS) treated with Radiation Therapy (RT)",
                    "criterion": "ipsilateral Ductal Carcinoma in Situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "Radiation Therapy (RT)"
                        }
                    ]
                },
                {
                    "exact_snippets": "history of Lobular Carcinoma in Situ (LCIS)",
                    "criterion": "Lobular Carcinoma in Situ (LCIS)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contralateral DCIS [regardless of RT]",
                    "criterion": "contralateral Ductal Carcinoma in Situ (DCIS)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "contralateral invasive breast cancer",
                    "criterion": "contralateral invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "History of non-breast malignancies ... within 5 years prior to randomization.",
                    "criterion": "non-breast malignancies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except for in situ cancers treated only by local excision",
                    "criterion": "in situ cancers",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "local excision"
                        }
                    ]
                },
                {
                    "exact_snippets": "except for ... basal cell and squamous cell carcinomas of the skin",
                    "criterion": "basal cell and squamous cell carcinomas of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known metastatic disease from any malignancy (solid tumor or hematologic).",
            "criterions": [
                {
                    "exact_snippets": "Known metastatic disease from any malignancy (solid tumor or hematologic)",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous therapy with anthracyclines, taxanes, cyclophosphamide, or eribulin for any malignancy.",
            "criterions": [
                {
                    "exact_snippets": "Previous therapy with anthracyclines",
                    "criterion": "previous therapy with anthracyclines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous therapy with ... taxanes",
                    "criterion": "previous therapy with taxanes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous therapy with ... cyclophosphamide",
                    "criterion": "previous therapy with cyclophosphamide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previous therapy with ... eribulin",
                    "criterion": "previous therapy with eribulin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.",
                    "criterion": "prior treatment for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "RT",
                                "chemotherapy",
                                "targeted therapy"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "prior to randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)",
            "criterions": [
                {
                    "exact_snippets": "Continued endocrine therapy such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor.",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy. Patients are eligible if these medications are discontinued prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Any continued sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy.",
                    "criterion": "continued sex hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Requirement for chronic use of any drugs known to prolong the QT interval, including Na+ and K+ channel blockers. (Patients are eligible if these medications and/or substances can be discontinued prior to the first dose of eribulin and will not need to be resumed until after the last dose of eribulin.)",
            "criterions": [
                {
                    "exact_snippets": "Requirement for chronic use of any drugs known to prolong the QT interval",
                    "criterion": "chronic use of drugs known to prolong the QT interval",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "including Na+ and K+ channel blockers",
                    "criterion": "use of Na+ and K+ channel blockers",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hepatitis B or hepatitis C with abnormal liver function tests.",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... hepatitis C",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "abnormal liver function tests",
                    "criterion": "liver function tests",
                    "requirements": [
                        {
                            "requirement_type": "normality",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intrinsic lung disease resulting in dyspnea.",
            "criterions": [
                {
                    "exact_snippets": "Intrinsic lung disease",
                    "criterion": "intrinsic lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dyspnea",
                    "criterion": "dyspnea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active infection; or chronic infection requiring chronic suppressive antibiotics.",
            "criterions": [
                {
                    "exact_snippets": "Active infection",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic infection requiring chronic suppressive antibiotics",
                    "criterion": "chronic infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "chronic suppressive antibiotics"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Persistent greater than or equal to grade 2 diarrhea regardless of etiology.",
            "criterions": [
                {
                    "exact_snippets": "Persistent greater than or equal to grade 2 diarrhea",
                    "criterion": "diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        },
                        {
                            "requirement_type": "persistence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sensory or motor neuropathy greater than or equal to grade 2, as defined by the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0.",
            "criterions": [
                {
                    "exact_snippets": "Sensory or motor neuropathy greater than or equal to grade 2",
                    "criterion": "sensory or motor neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication.",
            "criterions": [
                {
                    "exact_snippets": "Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication",
                    "criterion": "conditions prohibiting corticosteroid administration",
                    "requirements": [
                        {
                            "requirement_type": "prohibition",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids).",
            "criterions": [
                {
                    "exact_snippets": "Chronic daily treatment with corticosteroids",
                    "criterion": "corticosteroid treatment",
                    "requirements": [
                        {
                            "requirement_type": "frequency",
                            "expected_value": "chronic daily"
                        }
                    ]
                },
                {
                    "exact_snippets": "dose of greater than or equal to 10 mg/day methylprednisolone equivalent",
                    "criterion": "corticosteroid dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "mg/day methylprednisolone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "excluding inhaled steroids",
                    "criterion": "inhaled steroids",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled hypertension defined as a systolic BP > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medications. (Patients with hypertension that is well-controlled on medication are eligible.)",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled hypertension defined as a systolic BP > 150 mmHg",
                    "criterion": "systolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension defined as ... diastolic BP > 90 mmHg",
                    "criterion": "diastolic blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 90,
                                "unit": "mmHg"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled hypertension ... with or without anti-hypertensive medications",
                    "criterion": "hypertension control",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen. This includes but is not confined to: Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of Left Ventricular (LV) function; history of documented Congestive Heart Failure (CHF) documented cardiomyopathy; and congenital long QT syndrome.",
            "criterions": [
                {
                    "exact_snippets": "Cardiac disease (history of and/or active disease) that would preclude the use of any of the drugs included in the treatment regimen.",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "precludes use of treatment drugs"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active cardiac disease: symptomatic angina pectoris within the past 180 days that required the initiation of or increase in anti-anginal medication or other intervention",
                    "criterion": "symptomatic angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "recency",
                            "expected_value": {
                                "operator": "<=",
                                "value": 180,
                                "unit": "days"
                            }
                        },
                        {
                            "requirement_type": "treatment change",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ventricular arrhythmias except for benign premature ventricular contractions",
                    "criterion": "ventricular arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "benign premature ventricular contractions"
                        }
                    ]
                },
                {
                    "exact_snippets": "supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication",
                    "criterion": "supraventricular and nodal arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "pacemaker requirement",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "medication control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "conduction abnormality requiring a pacemaker",
                    "criterion": "conduction abnormality",
                    "requirements": [
                        {
                            "requirement_type": "pacemaker requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "valvular disease with documented compromise in cardiac function",
                    "criterion": "valvular disease",
                    "requirements": [
                        {
                            "requirement_type": "cardiac function compromise",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic pericarditis",
                    "criterion": "symptomatic pericarditis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of Left Ventricular (LV) function",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": [
                                "elevated cardiac enzymes",
                                "persistent regional wall abnormalities"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "history of documented Congestive Heart Failure (CHF)",
                    "criterion": "Congestive Heart Failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "documented cardiomyopathy",
                    "criterion": "cardiomyopathy",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congenital long QT syndrome",
                    "criterion": "congenital long QT syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.",
            "criterions": [
                {
                    "exact_snippets": "Other nonmalignant systemic disease that would preclude the patient from receiving study treatment",
                    "criterion": "nonmalignant systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on treatment",
                            "expected_value": "preclude from receiving study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "Other nonmalignant systemic disease that ... would prevent required follow-up",
                    "criterion": "nonmalignant systemic disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on follow-up",
                            "expected_value": "prevent required follow-up"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or lactation at the time of randomization.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy ... at the time of randomization.",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactation at the time of randomization.",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.",
            "criterions": [
                {
                    "exact_snippets": "Any psychiatric or addictive disorder",
                    "criterion": "psychiatric or addictive disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements",
                    "criterion": "other condition",
                    "requirements": [
                        {
                            "requirement_type": "investigator's opinion",
                            "expected_value": "would preclude her from meeting the study requirements"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of any investigation agent within 4 weeks prior to randomization.",
            "criterions": [
                {
                    "exact_snippets": "Use of any investigation agent within 4 weeks prior to randomization.",
                    "criterion": "investigation agent use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Serum potassium and serum magnesium performed within 4 weeks prior to randomization must be Within Normal Limits (WNL).",
            "criterions": [
                {
                    "exact_snippets": "Serum potassium ... must be Within Normal Limits (WNL).",
                    "criterion": "serum potassium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "Within Normal Limits (WNL)"
                        }
                    ]
                },
                {
                    "exact_snippets": "Serum magnesium ... must be Within Normal Limits (WNL).",
                    "criterion": "serum magnesium",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": "Within Normal Limits (WNL)"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}