{
"info": {
"nct_id": "NCT03703466",
"official_title": "An Open-Label, Randomized Phase 2 Study of the Impact of Food on Tolerability When Receiving Abemaciclib for Patients With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer",
"inclusion_criteria": "* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).\n* Have all of the following:\n\n * Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.\n * Prior treatment with chemotherapy for locally advanced or metastatic disease.\n * No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.\n* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.\n* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.\n* Have adequate organ function.\n* Women of child-bearing potential must have a negative pregnancy test.\n* Are able to swallow tablets/capsules.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Are currently receiving treatment in a clinical study involving an investigational product.\n* Have a serious concomitant systemic disorder.\n* Have symptomatic central nervous system (CNS) malignancy or metastasis.\n* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.\n* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.\n* Have a history of any other cancer.\n* Had major surgery within 14 days prior to randomization.\n* Are breastfeeding.\n* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.",
"miscellaneous_criteria": ""
},
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"identified_line": {
"line": "* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).",
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{
"exact_snippets": "HER2-",
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"exact_snippets": "metastatic breast cancer (mBC)",
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}
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"identified_line": {
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]
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