{
    "info": {
        "nct_id": "NCT00003972",
        "official_title": "A Phase III Study of High-Dose Chemotherapy Using Busulfan, Melphalan and Thiotepa Versus Cyclophosphamide,Thiotepa, Carboplatin Followed by Autologous Stem Cell Transplantation in Patients With High-Risk Primary Stage II or III (Non-Inflammatory) Breast Cancer",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 65 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Histologically proven stage II breast cancer with 1 of the following: Estrogen receptor negative with at least 4 positive nodes OR Estrogen receptor positive with at least 6 positive nodes OR Histologically proven stage IIIA breast cancer Must have already received 4-7 courses of conventional chemotherapy with a doxorubicin based regimen (which may include paclitaxel or docetaxel) No greater than 60 days since induction chemotherapy Prior definitive surgical treatment of primary lesion (modified radical mastectomy or breast conserving procedure plus axillary node dissection) Margins free of tumor Hormone receptor status: Estrogen and progesterone receptor status known\n\nPATIENT CHARACTERISTICS: Age: 18 to 65 Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 50% if any of the following: Symptoms of congestive heart failure Abnormal cardiac exam Prior doxorubicin dose greater than 400 mg/m2 Pulmonary: No significant pulmonary disease (DLCO less than 60% predicted) Other: Not pregnant Negative pregnancy test HIV negative No significant active infection No other severe disease that would severely limit life expectancy No other malignancy within past 5 years unless: Chance of survival for greater than 5 years is 90% AND Treated with surgery only (no chemotherapy or radiotherapy)\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior chemotherapy regimen (no greater than 7 prior courses) Endocrine therapy: No concurrent tamoxifen Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No other concurrent experimental agents"
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 65 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 65 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 65,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Histologically proven stage II breast cancer with 1 of the following: Estrogen receptor negative with at least 4 positive nodes OR Estrogen receptor positive with at least 6 positive nodes OR Histologically proven stage IIIA breast cancer Must have already received 4-7 courses of conventional chemotherapy with a doxorubicin based regimen (which may include paclitaxel or docetaxel) No greater than 60 days since induction chemotherapy Prior definitive surgical treatment of primary lesion (modified radical mastectomy or breast conserving procedure plus axillary node dissection) Margins free of tumor Hormone receptor status: Estrogen and progesterone receptor status known",
            "criterions": [
                {
                    "exact_snippets": "Histologically proven stage II breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "II"
                        }
                    ]
                },
                {
                    "exact_snippets": "Estrogen receptor negative with at least 4 positive nodes",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Estrogen receptor negative with at least 4 positive nodes",
                    "criterion": "positive nodes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "nodes"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Estrogen receptor positive with at least 6 positive nodes",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Estrogen receptor positive with at least 6 positive nodes",
                    "criterion": "positive nodes",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "nodes"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Histologically proven stage IIIA breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "IIIA"
                        }
                    ]
                },
                {
                    "exact_snippets": "Must have already received 4-7 courses of conventional chemotherapy",
                    "criterion": "chemotherapy courses",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 4,
                                        "unit": "courses"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 7,
                                        "unit": "courses"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "doxorubicin based regimen (which may include paclitaxel or docetaxel)",
                    "criterion": "chemotherapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "doxorubicin",
                                "paclitaxel",
                                "docetaxel"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "No greater than 60 days since induction chemotherapy",
                    "criterion": "time since induction chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior definitive surgical treatment of primary lesion",
                    "criterion": "surgical treatment of primary lesion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "modified radical mastectomy or breast conserving procedure plus axillary node dissection",
                    "criterion": "surgical procedure type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "modified radical mastectomy",
                                "breast conserving procedure plus axillary node dissection"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Margins free of tumor",
                    "criterion": "tumor margins",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "free of tumor"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hormone receptor status: Estrogen and progesterone receptor status known",
                    "criterion": "hormone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "knowledge",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 18 to 65 Menopausal status: Not specified Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2 times normal Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at least 50% if any of the following: Symptoms of congestive heart failure Abnormal cardiac exam Prior doxorubicin dose greater than 400 mg/m2 Pulmonary: No significant pulmonary disease (DLCO less than 60% predicted) Other: Not pregnant Negative pregnancy test HIV negative No significant active infection No other severe disease that would severely limit life expectancy No other malignancy within past 5 years unless: Chance of survival for greater than 5 years is 90% AND Treated with surgery only (no chemotherapy or radiotherapy)",
            "criterions": [
                {
                    "exact_snippets": "Age: 18 to 65",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 65,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Menopausal status: Not specified",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: Karnofsky 70-100%",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "%"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "%"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Life expectancy: Not specified",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematopoietic: Not specified",
                    "criterion": "hematopoietic",
                    "requirements": [
                        {
                            "requirement_type": "specification",
                            "expected_value": "Not specified"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 2.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT or SGPT no greater than 2 times normal",
                    "criterion": "SGOT or SGPT level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": "no greater than 2 times normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 2.0 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine clearance at least 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: Left ventricular ejection fraction at least 50%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Symptoms of congestive heart failure",
                    "criterion": "symptoms of congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Abnormal cardiac exam",
                    "criterion": "abnormal cardiac exam",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior doxorubicin dose greater than 400 mg/m2",
                    "criterion": "prior doxorubicin dose",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">",
                                "value": 400,
                                "unit": "mg/m2"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Pulmonary: No significant pulmonary disease (DLCO less than 60% predicted)",
                    "criterion": "significant pulmonary disease",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "DLCO less than 60% predicted",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "% predicted"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "No significant active infection",
                    "criterion": "significant active infection",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No other severe disease that would severely limit life expectancy",
                    "criterion": "severe disease limiting life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No other malignancy within past 5 years",
                    "criterion": "other malignancy within past 5 years",
                    "requirements": [
                        {
                            "requirement_type": "absence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Chance of survival for greater than 5 years is 90%",
                    "criterion": "chance of survival for greater than 5 years",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": "=",
                                "value": 90,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Treated with surgery only (no chemotherapy or radiotherapy)",
                    "criterion": "treatment type for malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "surgery only"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No greater than 1 prior chemotherapy regimen (no greater than 7 prior courses) Endocrine therapy: No concurrent tamoxifen Radiotherapy: Not specified Surgery: See Disease Characteristics Other: No other concurrent experimental agents",
            "criterions": [
                {
                    "exact_snippets": "No greater than 1 prior chemotherapy regimen",
                    "criterion": "prior chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no greater than 7 prior courses",
                    "criterion": "prior chemotherapy courses",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent tamoxifen",
                    "criterion": "concurrent tamoxifen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No other concurrent experimental agents",
                    "criterion": "concurrent experimental agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}