{
    "info": {
        "nct_id": "NCT01853748",
        "official_title": "A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)",
        "inclusion_criteria": "* HER2-positive Stage I histologically confirmed invasive carcinoma of the breast\n* ER/PR determination is required\n* HER2 positive, confirmed by central testing: IHC 3+, FISH HER2/CEP17 <2.0 with an average HER2 copy number >/=6.0, or FISH HER2/CEP17 >/= 2.0\n* Bilateral breast cancers that individually meet eligibility criteria are allowed\n* Subjects with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria\n* Subjects with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; Patients with a history of contralateral DCIS are not eligible.\n* Should have tumor tissue available and a tissue block of sufficient size to make 15 slides, which must be sent to a DFCI site for testing\n* Less than or equal to 90 days since most recent breast surgery for this breast cancer\n* All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy) with either a sentinel node biopsy or axillary dissection\n* All margins should be clear of invasive cancer or DCIS\n* May have received up to 4 weeks of tamoxifen therapy or other hormonal therapy, for adjuvant therapy for this cancer\n* Prior oophorectomy for cancer prevention is allowed\n* Subjects who have undergone partial breast radiation (duration </= 7 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy.\n* Must have discontinued any investigational drug at least 2 weeks prior to participation\n* Willing to use one highly effective from of nonhormonal contraception or two effective forms of nonhormonal contraception while on study and for 7 months after end of study treatment\n* Subjects undergoing lumpectomy must have no contraindications to radiation therapy\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Pregnant or breastfeeding\n* Use of potent CYP3A4 inhibitors during the study treatment period\n* Excessive alcohol intake (more than 3 alcoholic beverages per day)\n* Locally advanced tumors at diagnosis\n* History of previous invasive breast cancer\n* History of prior chemotherapy in the past 5 years\n* History of prior trastuzumab or prior paclitaxel therapy\n* Active, unresolved infection\n* Active liver disease\n* History of a different malignancy except for the following: disease free for at least 5 years and at low risk for recurrence; cervical cancer in situ, basal or squamous cell carcinoma of the skin\n* Active cardiac disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* HER2-positive Stage I histologically confirmed invasive carcinoma of the breast",
            "criterions": [
                {
                    "exact_snippets": "HER2-positive",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Stage I",
                    "criterion": "cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "I"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "invasive carcinoma of the breast",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "invasive carcinoma of the breast"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ER/PR determination is required",
            "criterions": [
                {
                    "exact_snippets": "ER/PR determination is required",
                    "criterion": "ER/PR determination",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HER2 positive, confirmed by central testing: IHC 3+, FISH HER2/CEP17 <2.0 with an average HER2 copy number >/=6.0, or FISH HER2/CEP17 >/= 2.0",
            "criterions": [
                {
                    "exact_snippets": "HER2 positive, confirmed by central testing",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        },
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "central testing"
                        }
                    ]
                },
                {
                    "exact_snippets": "IHC 3+",
                    "criterion": "IHC score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": "3+"
                        }
                    ]
                },
                {
                    "exact_snippets": "FISH HER2/CEP17 <2.0",
                    "criterion": "FISH HER2/CEP17 ratio",
                    "requirements": [
                        {
                            "requirement_type": "ratio",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "average HER2 copy number >/=6.0",
                    "criterion": "HER2 copy number",
                    "requirements": [
                        {
                            "requirement_type": "average copy number",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "FISH HER2/CEP17 >/= 2.0",
                    "criterion": "FISH HER2/CEP17 ratio",
                    "requirements": [
                        {
                            "requirement_type": "ratio",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.0,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilateral breast cancers that individually meet eligibility criteria are allowed",
            "criterions": [
                {
                    "exact_snippets": "Bilateral breast cancers",
                    "criterion": "bilateral breast cancers",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "individually meet eligibility criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with multifocal or multicentric disease are eligible as long as each tumor individually meets eligibility criteria",
            "criterions": [
                {
                    "exact_snippets": "multifocal or multicentric disease",
                    "criterion": "disease type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "multifocal",
                                "multicentric"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "each tumor individually meets eligibility criteria",
                    "criterion": "tumor eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": "meets criteria"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; Patients with a history of contralateral DCIS are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "history of ipsilateral DCIS",
                    "criterion": "ipsilateral DCIS",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treated with wide-excision alone, without radiation therapy",
                    "criterion": "treatment for ipsilateral DCIS",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "wide-excision alone"
                        },
                        {
                            "requirement_type": "radiation therapy",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of contralateral DCIS",
                    "criterion": "contralateral DCIS",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Should have tumor tissue available and a tissue block of sufficient size to make 15 slides, which must be sent to a DFCI site for testing",
            "criterions": [
                {
                    "exact_snippets": "tumor tissue available",
                    "criterion": "tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tissue block of sufficient size to make 15 slides",
                    "criterion": "tissue block size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">=",
                                "value": 15,
                                "unit": "slides"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "must be sent to a DFCI site for testing",
                    "criterion": "tissue block testing location",
                    "requirements": [
                        {
                            "requirement_type": "location",
                            "expected_value": "DFCI site"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Less than or equal to 90 days since most recent breast surgery for this breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Less than or equal to 90 days since most recent breast surgery",
                    "criterion": "time since most recent breast surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All tumor should be removed by either a modified radical mastectomy or a segmental mastectomy (lumpectomy) with either a sentinel node biopsy or axillary dissection",
            "criterions": [
                {
                    "exact_snippets": "All tumor should be removed",
                    "criterion": "tumor removal",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "modified radical mastectomy",
                    "criterion": "surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "modified radical mastectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "segmental mastectomy (lumpectomy)",
                    "criterion": "surgical procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "segmental mastectomy (lumpectomy)"
                        }
                    ]
                },
                {
                    "exact_snippets": "sentinel node biopsy",
                    "criterion": "lymph node procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "sentinel node biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "axillary dissection",
                    "criterion": "lymph node procedure",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "axillary dissection"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All margins should be clear of invasive cancer or DCIS",
            "criterions": [
                {
                    "exact_snippets": "All margins should be clear of invasive cancer",
                    "criterion": "margins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "All margins should be clear of ... DCIS",
                    "criterion": "margins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* May have received up to 4 weeks of tamoxifen therapy or other hormonal therapy, for adjuvant therapy for this cancer",
            "criterions": [
                {
                    "exact_snippets": "received up to 4 weeks of tamoxifen therapy or other hormonal therapy",
                    "criterion": "tamoxifen or other hormonal therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant therapy for this cancer",
                    "criterion": "adjuvant therapy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "for this cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior oophorectomy for cancer prevention is allowed",
            "criterions": [
                {
                    "exact_snippets": "Prior oophorectomy for cancer prevention is allowed",
                    "criterion": "prior oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "cancer prevention"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects who have undergone partial breast radiation (duration </= 7 days) prior to registration are eligible. Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy.",
            "criterions": [
                {
                    "exact_snippets": "Subjects who have undergone partial breast radiation",
                    "criterion": "partial breast radiation",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "duration </= 7 days",
                    "criterion": "partial breast radiation duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Partial breast radiation must be completed prior to 2 weeks before starting protocol therapy",
                    "criterion": "partial breast radiation completion time",
                    "requirements": [
                        {
                            "requirement_type": "completion time",
                            "expected_value": "prior to 2 weeks before starting protocol therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Must have discontinued any investigational drug at least 2 weeks prior to participation",
            "criterions": [
                {
                    "exact_snippets": "Must have discontinued any investigational drug at least 2 weeks prior to participation",
                    "criterion": "investigational drug",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation period",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Willing to use one highly effective from of nonhormonal contraception or two effective forms of nonhormonal contraception while on study and for 7 months after end of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Willing to use one highly effective from of nonhormonal contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "highly effective nonhormonal"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "while on study and for 7 months after end of study treatment"
                        }
                    ]
                },
                {
                    "exact_snippets": "two effective forms of nonhormonal contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "two effective nonhormonal"
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": "while on study and for 7 months after end of study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects undergoing lumpectomy must have no contraindications to radiation therapy",
            "criterions": [
                {
                    "exact_snippets": "Subjects undergoing lumpectomy",
                    "criterion": "lumpectomy",
                    "requirements": [
                        {
                            "requirement_type": "undergoing",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "no contraindications to radiation therapy",
                    "criterion": "contraindications to radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnant or breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of potent CYP3A4 inhibitors during the study treatment period",
            "criterions": [
                {
                    "exact_snippets": "Use of potent CYP3A4 inhibitors during the study treatment period",
                    "criterion": "CYP3A4 inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Excessive alcohol intake (more than 3 alcoholic beverages per day)",
            "criterions": [
                {
                    "exact_snippets": "Excessive alcohol intake (more than 3 alcoholic beverages per day)",
                    "criterion": "alcohol intake",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "alcoholic beverages per day"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Locally advanced tumors at diagnosis",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced tumors",
                    "criterion": "tumor stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "locally advanced"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of previous invasive breast cancer",
            "criterions": [
                {
                    "exact_snippets": "History of previous invasive breast cancer",
                    "criterion": "invasive breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of prior chemotherapy in the past 5 years",
            "criterions": [
                {
                    "exact_snippets": "History of prior chemotherapy in the past 5 years",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 5 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of prior trastuzumab or prior paclitaxel therapy",
            "criterions": [
                {
                    "exact_snippets": "History of prior trastuzumab",
                    "criterion": "trastuzumab therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of prior ... prior paclitaxel therapy",
                    "criterion": "paclitaxel therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active, unresolved infection",
            "criterions": [
                {
                    "exact_snippets": "Active, unresolved infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active liver disease",
            "criterions": [
                {
                    "exact_snippets": "Active liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of a different malignancy except for the following: disease free for at least 5 years and at low risk for recurrence; cervical cancer in situ, basal or squamous cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "History of a different malignancy",
                    "criterion": "history of different malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "disease free for at least 5 years",
                    "criterion": "disease-free period",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "at low risk for recurrence",
                    "criterion": "risk for recurrence",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "cervical cancer in situ",
                    "criterion": "cervical cancer in situ",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "basal or squamous cell carcinoma of the skin",
                    "criterion": "basal or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "Active cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}