Information:
Fel:
ID
36076
Beskrivning
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT02422199
Länk
https://clinicaltrials.gov/show/NCT02422199
Nyckelord
Versioner (1)
- 2019-04-14 2019-04-14 -
Rättsinnehavare
See clinicaltrials.gov
Uppladdad den
14 april 2019
DOI
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Licens
Creative Commons BY 4.0
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Eligibility HER2 Positive Metastatic Breast Cancer NCT02422199
Eligibility HER2 Positive Metastatic Breast Cancer NCT02422199
- StudyEvent: Eligibility
Similar models
Eligibility HER2 Positive Metastatic Breast Cancer NCT02422199
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Age
Item
aged ≥18 and ≤70 years.
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 to 1.
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of more than 12 weeks.
boolean
C0023671 (UMLS CUI [1])
Measurable lesion Quantity
Item
at least one measurable lesion exists.(recist 1.1).
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,2])
Advanced breast cancer HER2 Positive | Prior Therapy failed
Item
histologically or cytologic confirmed her2 positive advanced breast cancer which failed prior therapies.
boolean
C3495917 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C2348909 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Laboratory Results Required
Item
required laboratory values including following parameters:
boolean
C1254595 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,2])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement | Serum total bilirubin measurement
Item
anc: ≥ 1.5 x 10^9/l;platelet count: ≥ 100 x 10^9/l;hemoglobin: ≥ 9.0 g/dl;total bilirubin:
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Blood urea nitrogen measurement | Creatinine clearance measurement | Left ventricular ejection fraction | QTcF - Fridericia's Correction Formula | Gender
Item
≤ 1.5 x upper limit of normal (uln);alt and ast: ≤ 1.5 x uln;bun and creatine clearance rate: ≥ 50 ml/min;lvef: ≥ 50%;qtcf: < 470 ms for female and < 450 ms for male.
boolean
C0201836 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0005845 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0428772 (UMLS CUI [5])
C1882513 (UMLS CUI [6])
C0079399 (UMLS CUI [7])
C0201899 (UMLS CUI [2])
C0005845 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0428772 (UMLS CUI [5])
C1882513 (UMLS CUI [6])
C0079399 (UMLS CUI [7])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
lapatinib | neratinib | pyrotinib | HER2 Targeted Tyrosine kinase inhibitor
Item
received previous therapy with lapatinib, neratinib, pyrotinib or any other her2 directe tyrosine kinase inhibitor.
boolean
C1506770 (UMLS CUI [1])
C2713008 (UMLS CUI [2])
C3828434 (UMLS CUI [3])
C0069515 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C1268567 (UMLS CUI [4,3])
C2713008 (UMLS CUI [2])
C3828434 (UMLS CUI [3])
C0069515 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C1268567 (UMLS CUI [4,3])
capecitabine
Item
received previous therapy with capecitabine within 3 months.
boolean
C0671970 (UMLS CUI [1])