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Triage: High /protocolSection/eligibilityModule/eligibilityCriteria Matched rules
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eligibility_criteria_changeEligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ul><li>Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.</li><li>Age between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.</li><li>Patients can not have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.</li><li>Performance status of 0,1, 2 (ECOG). Al least a 6 months life expectancy. Neutrophils > 1500, platelets > 100000, haemoglobin > 10 mg/dL.</li><li>Adequate renal and hepatic functions, with serum creatinine < 1,2 mg/dl and total bilirubin < 2 mg/dl.</li><li>Adequate contraceptive methods during the study and up to 3 months after.</li><li>Adequate cardiac function assessed by physical exam, EKG and LVEF > 55%.</li></ul><p>Exclusion Criteria:</p><ul><li>Inflammatory carcinoma or stage I, II or IV breast cancer disease.</li><li>Males.</li><li>Active infection.</li><li>Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.</li></ul><p>Concomitant serious diseased provoking organs failure (heart, renal, hepatic, respiratory).</p><ul><li>Pre-existing motor or sensorial neuropathy > grade 1.</li><li>Inability for treatment compliance.</li><li>History of hypersensitivity to compound such as cremophor, cyclosporine or vitamin K.</li><li>History of arrhythmias or congestive heart failure, even when controlled, or active cardiac blocking of second or third grade. History of myocardial infarction in the previous 6 months. HT nor controlled.</li><li>Pregnant or lactating women.</li></ul>
After
<p>Inclusion Criteria:</p><ul><li>Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.</li><li>Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.</li><li>Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.</li><li>Performance status of 0,1, 2 (ECOG).</li><li>At least a 6 month life expectancy.</li><li>Neutrophils > 1500; platelets > 100000; haemoglobin > 10 mg/dL.</li><li>Adequate renal and hepatic functions, with serum creatinine < 1.2 mg/dl and total bilirubin < 2 mg/dl.</li><li>Adequate contraceptive methods during the study and up to 3 months after.</li><li>Adequate cardiac function assessed by physical exam, electrocardiogram (EKG) and left ventricular ejection fraction (LVEF) > 55%.</li></ul><p>Exclusion Criteria:</p><ul><li>Inflammatory carcinoma or stage I, II or IV breast cancer disease.</li><li>Males.</li><li>Active infection.</li><li>Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.</li><li>Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).</li><li>Pre-existing motor or sensorial neuropathy > grade 1.</li><li>Inability for treatment compliance.</li><li>History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.</li><li>History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.</li><li>History of myocardial infarction in the previous 6 months.</li><li>Hypertension (HT) not controlled.</li><li>Pregnant or lactating women.</li></ul>