{
    "info": {
        "nct_id": "NCT01202591",
        "official_title": "A Randomised Double-blind Phase IIa Study (With Combination Safety Run-in) to Assess the Safety and Efficacy of AZD4547 in Combination With Fulvestrant vs. Fulvestrant Alone in ER+ Breast Cancer Patients With FGFR1 Polysomy or Gene Amplification Who Have Progressed Following Treatment With Prior Endocrine Therapy (Adjuvant or First-line Metastatic) (GLOW)",
        "inclusion_criteria": "* Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)\n* Histological confirmation of Breast Cancer with documented ER+ receptor status\n* Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL\n* Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.\n* Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.\n* More than 1 prior regimen of chemotherapy for breast cancer\n* ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction\n* History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.\n* Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)",
            "criterions": [
                {
                    "exact_snippets": "Post-menopausal women",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post-menopausal"
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral oophorectomy",
                    "criterion": "surgical history",
                    "requirements": [
                        {
                            "requirement_type": "procedure",
                            "expected_value": "bilateral oophorectomy"
                        }
                    ]
                },
                {
                    "exact_snippets": "amenorrhoeic for 24 months",
                    "criterion": "amenorrhea duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 24,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histological confirmation of Breast Cancer with documented ER+ receptor status",
            "criterions": [
                {
                    "exact_snippets": "Histological confirmation of Breast Cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histological"
                        }
                    ]
                },
                {
                    "exact_snippets": "documented ER+ receptor status",
                    "criterion": "ER receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "ER+"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Safety run-in: Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal AL",
            "criterions": [
                {
                    "exact_snippets": "Relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy",
                    "criterion": "relapse timing",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 12,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "completion of a single regimen of adjuvant endocrine therapy with non-steroidal AI and/ tamoxifen",
                    "criterion": "adjuvant endocrine therapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "completion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "non-steroidal AI",
                                "tamoxifen"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "progression following 1st line endocrine therapy with non-steroidal AL",
                    "criterion": "progression after 1st line endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-steroidal AL"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rand phase IIa: Received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both). Chemotherapy administered in the adjuvant setting is permitted.",
            "criterions": [
                {
                    "exact_snippets": "Received at least 1 prior endocrine therapy in the metastatic setting",
                    "criterion": "prior endocrine therapy in the metastatic setting",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "therapy"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed during/ within 6 months of completion of adjuvant endocrine therapy",
                    "criterion": "relapse timing after adjuvant endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "during/ within 6 months of completion"
                        }
                    ]
                },
                {
                    "exact_snippets": "adjuvant endocrine therapy (either non-steroidal AI or tamoxifen or a combination of both)",
                    "criterion": "type of adjuvant endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "non-steroidal AI",
                                "tamoxifen",
                                "combination of both"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Chemotherapy administered in the adjuvant setting is permitted",
                    "criterion": "adjuvant chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Rand phase IIa: Mandatory provision of tumour sample to confirm FGFR1 polysomy or gene amplification. At least one measurable lesion that can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits",
            "criterions": [
                {
                    "exact_snippets": "Mandatory provision of tumour sample",
                    "criterion": "tumour sample",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "confirm FGFR1 polysomy or gene amplification",
                    "criterion": "FGFR1",
                    "requirements": [
                        {
                            "requirement_type": "polysomy or gene amplification",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "At least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "can be accurately assessed by CT/MRI/x-ray at baseline and follow up visits",
                    "criterion": "lesion assessment",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "CT",
                                "MRI",
                                "x-ray"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": [
                                "baseline",
                                "follow up visits"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase IIa), or any agent known to inhibit FGFRs.",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to exemestane",
                    "criterion": "prior exposure to exemestane",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... fulvestrant",
                    "criterion": "prior exposure to fulvestrant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Prior exposure to ... any agent known to inhibit FGFRs",
                    "criterion": "prior exposure to FGFR inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* More than 1 prior regimen of chemotherapy for breast cancer",
            "criterions": [
                {
                    "exact_snippets": "More than 1 prior regimen of chemotherapy for breast cancer",
                    "criterion": "prior chemotherapy regimens for breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECG recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction",
            "criterions": [
                {
                    "exact_snippets": "ECG recordings that demonstrate significant abnormalities in cardiac rate",
                    "criterion": "cardiac rate",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECG recordings that demonstrate significant abnormalities in cardiac ... rhythm",
                    "criterion": "cardiac rhythm",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ECG recordings that demonstrate significant abnormalities in cardiac ... conduction",
                    "criterion": "cardiac conduction",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of hypersensitivity to active or inactive excipients of AZD4547 or exemestane (safety run-in ) or fulvestrant (Randomized phase), including castor oil, or drugs with a similar chemical structure or class to AZD4547 or exemestane or fulvestrant.",
            "criterions": [
                {
                    "exact_snippets": "History of hypersensitivity to active or inactive excipients of AZD4547",
                    "criterion": "hypersensitivity to AZD4547 excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to active or inactive excipients of ... exemestane (safety run-in )",
                    "criterion": "hypersensitivity to exemestane excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to active or inactive excipients of ... fulvestrant (Randomized phase)",
                    "criterion": "hypersensitivity to fulvestrant excipients",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to ... castor oil",
                    "criterion": "hypersensitivity to castor oil",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to ... drugs with a similar chemical structure or class to AZD4547",
                    "criterion": "hypersensitivity to drugs similar to AZD4547",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to ... drugs with a similar chemical structure or class to ... exemestane",
                    "criterion": "hypersensitivity to drugs similar to exemestane",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of hypersensitivity to ... drugs with a similar chemical structure or class to ... fulvestrant",
                    "criterion": "hypersensitivity to drugs similar to fulvestrant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Randomized phase IIa: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks",
            "criterions": [
                {
                    "exact_snippets": "bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks",
                    "criterion": "bleeding/blood clotting conditions",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "would prevent the administration of the fulvestrant injection into the buttocks"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}