{
    "info": {
        "nct_id": "NCT03633331",
        "official_title": "A Phase II Trial Assessing the Tolerability of Palbociclib in Combination With Letrozole or Fulvestrant in Patients Aged 70 and Older With Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer",
        "inclusion_criteria": "* Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required\n* Measurable disease or non-measurable disease\n* Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration\n* No prior therapy with a CDK inhibitor\n* Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration\n* No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible\n* No known interstitial lung disease\n* No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for >= 3 years\n* No active infection requiring treatment with antibiotics\n* Patients must be able to swallow and retain oral medication\n* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2\n* Patients must be able to read and comprehend English or Spanish\n* Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)\n* Platelet count >= 100,000/mm^3 (100 x 10^9/L)\n* Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula\n* Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)\n* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)\n* Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)\nHealthy volunteers allowed\nMust have minimum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Documentation of disease: estrogen receptor positive and/or progesterone receptor (PR) positive, HER2 negative metastatic breast cancer; histologic confirmation is required",
            "criterions": [
                {
                    "exact_snippets": "estrogen receptor positive",
                    "criterion": "estrogen receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "progesterone receptor (PR) positive",
                    "criterion": "progesterone receptor status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "HER2 negative",
                    "criterion": "HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic breast cancer",
                    "criterion": "breast cancer stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": "metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic confirmation is required",
                    "criterion": "histologic confirmation",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease or non-measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "measurable"
                        }
                    ]
                },
                {
                    "exact_snippets": "non-measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-measurable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Planning to begin palbociclib for metastatic disease; one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed; patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Planning to begin palbociclib for metastatic disease",
                    "criterion": "palbociclib treatment",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one prior line of endocrine therapy and/or chemotherapy for metastatic disease is allowed",
                    "criterion": "prior therapy for metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients may begin or have already begun endocrine therapy before they start palbociclib treatment, but no more than two weeks prior to registration",
                    "criterion": "endocrine therapy start time",
                    "requirements": [
                        {
                            "requirement_type": "time before registration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior therapy with a CDK inhibitor",
            "criterions": [
                {
                    "exact_snippets": "No prior therapy with a CDK inhibitor",
                    "criterion": "prior therapy with a CDK inhibitor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =< 1 (except alopecia) or to baseline toxicities prior to previous therapy or surgical procedures, prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Resolution of all acute toxic effects of prior therapy or surgical procedures to CTCAE grade =< 1",
                    "criterion": "acute toxic effects of prior therapy or surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Resolution of all acute toxic effects of prior therapy or surgical procedures ... to baseline toxicities prior to previous therapy or surgical procedures",
                    "criterion": "acute toxic effects of prior therapy or surgical procedures",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "baseline toxicities prior to previous therapy or surgical procedures"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No untreated brain metastases; patients with treated brain metastases must have completed treatment with steroids to be eligible",
            "criterions": [
                {
                    "exact_snippets": "No untreated brain metastases",
                    "criterion": "untreated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with treated brain metastases must have completed treatment with steroids",
                    "criterion": "treated brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "treatment completion",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "steroid treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No known interstitial lung disease",
            "criterions": [
                {
                    "exact_snippets": "No known interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ; however, patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for >= 3 years",
            "criterions": [
                {
                    "exact_snippets": "No second malignancies other than non-melanoma skin cancers or cervical carcinoma in situ",
                    "criterion": "second malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "non-melanoma skin cancers",
                                "cervical carcinoma in situ"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients are not considered to have a \"currently active\" malignancy if they have completed therapy and are free of disease for >= 3 years",
                    "criterion": "currently active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time since therapy completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No active infection requiring treatment with antibiotics",
            "criterions": [
                {
                    "exact_snippets": "No active infection requiring treatment with antibiotics",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No active infection requiring treatment with antibiotics",
                    "criterion": "treatment with antibiotics",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to swallow and retain oral medication",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to swallow",
                    "criterion": "ability to swallow",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "retain oral medication",
                    "criterion": "ability to retain oral medication",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1",
                                "2"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be able to read and comprehend English or Spanish",
            "criterions": [
                {
                    "exact_snippets": "Patients must be able to read and comprehend English or Spanish",
                    "criterion": "language comprehension",
                    "requirements": [
                        {
                            "requirement_type": "languages",
                            "expected_value": [
                                "English",
                                "Spanish"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) >= 1500/mm^3 (1.5 x 10^9/L)",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count >= 100,000/mm^3 (100 x 10^9/L)",
            "criterions": [
                {
                    "exact_snippets": "Platelet count >= 100,000/mm^3 (100 x 10^9/L)",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm^3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance >= 30 ml/min calculated using the Cockcroft-Gault formula",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance >= 30 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "ml/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "calculated using the Cockcroft-Gault formula",
                    "criterion": "calculation method for creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "Cockcroft-Gault formula"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total serum bilirubin =< 1.5 upper limit of normal (ULN) (< 3 ULN if Gilbert's disease)",
            "criterions": [
                {
                    "exact_snippets": "Total serum bilirubin =< 1.5 upper limit of normal (ULN)",
                    "criterion": "total serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Total serum bilirubin ... (< 3 ULN if Gilbert's disease)",
                    "criterion": "total serum bilirubin with Gilbert's disease",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 3,
                                        "unit": "ULN"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN if bone or liver metastases present)",
            "criterions": [
                {
                    "exact_snippets": "Alkaline phosphatase =< 2.5 x ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Alkaline phosphatase ... =< 5 x ULN if bone or liver metastases present",
                    "criterion": "alkaline phosphatase with bone or liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)",
            "criterions": [
                {
                    "exact_snippets": "Aspartate aminotransferase (AST) ... =< 3 x ULN (=< 5.0 x ULN if liver metastases present)",
                    "criterion": "aspartate aminotransferase (AST)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) =< 3 x ULN (=< 5.0 x ULN if liver metastases present)",
                    "criterion": "alanine aminotransferase (ALT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ... =< 5.0 x ULN if liver metastases present",
                    "criterion": "liver metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}