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Information:
Fel:
ID
13871
Beskrivning
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01288092
Länk
https://clinicaltrials.gov/show/NCT01288092
Nyckelord
Versioner (2)
- 2016-03-13 2016-03-13 -
- 2021-09-20 2021-09-20 -
Uppladdad den
13 mars 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT01288092
Eligibility Metastatic Breast Cancer NCT01288092
- StudyEvent: Eligibility
Similar models
Eligibility Metastatic Breast Cancer NCT01288092
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
female; age
Item
female ≥ 18 years
boolean
C0015780 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0001779 (UMLS CUI [2])
ecog performance status
Item
ecog performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Neoplasm Metastasis breast cancer; Hormone receptor positive tumor; her2 negative breast cancer
Item
histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and her2 negative)
boolean
C0027627 (UMLS CUI [1,1])
C0006142 (UMLS CUI [1,2])
C1563119 (UMLS CUI [2])
C2316304 (UMLS CUI [3])
C0006142 (UMLS CUI [1,2])
C1563119 (UMLS CUI [2])
C2316304 (UMLS CUI [3])
phosphoinositide-3-kinase, catalytic alpha; mutation PTEN gene
Item
known pi3k activation status (defined by pik3ca (phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and pten pten (phosphatase and tensin homolog) mutation/expression)
boolean
C1310696 (UMLS CUI [1])
C0026882 (UMLS CUI [2,1])
C0694888 (UMLS CUI [2,2])
C0026882 (UMLS CUI [2,1])
C0694888 (UMLS CUI [2,2])
endocrine therapy; chemotherapy metastatic breast cancer
Item
prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer
boolean
C0279025 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0278488 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,1])
C0278488 (UMLS CUI [2,2])
Measurable Disease; Cancer Progression
Item
objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per recist
boolean
C1513041 (UMLS CUI [1])
C1947901 (UMLS CUI [2])
C1947901 (UMLS CUI [2])
organ function; bone marrow function
Item
adequate bone marrow and organ function
boolean
C0678852 (UMLS CUI [1])
C0412480 (UMLS CUI [2])
C0412480 (UMLS CUI [2])
mtor inhibitors; phosphoinositide-3-kinase
Item
previous treatment with pi3k and/or mtor inhibitors
boolean
C1515672 (UMLS CUI [1])
C1310696 (UMLS CUI [2])
C1310696 (UMLS CUI [2])
cns metastase
Item
symptomatic central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
malignancy
Item
concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
boolean
C0006826 (UMLS CUI [1])
field radiotherapy; palliation radiation
Item
wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
boolean
C3826993 (UMLS CUI [1])
C0475092 (UMLS CUI [2])
C0475092 (UMLS CUI [2])
left ventricular ejection fraction; qtcf; electrocardiogram; Angina, Unstable; Cardiac Arrhythmia
Item
active cardiac disease (e.g. left ventricular ejection fraction (lvef) < 50%, qtcf > 480 msec on screening ecgelectrocardiogram (ecg), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
boolean
C0428772 (UMLS CUI [1])
C1882513 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C1882513 (UMLS CUI [2])
C0013798 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
hypertension
Item
inadequately controlled hypertension
boolean
C0020538 (UMLS CUI [1])
gastrointestinal disease; absorption bez235
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235
boolean
C0017178 (UMLS CUI [1])
C2698776 (UMLS CUI [2,1])
C2347425 (UMLS CUI [2,2])
C2698776 (UMLS CUI [2,1])
C2347425 (UMLS CUI [2,2])
torsades de pointes; cyp3a4 inhibitor; warfarin; coumadin
Item
treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists
boolean
C0040479 (UMLS CUI [1])
C3830624 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0699129 (UMLS CUI [4])
C3830624 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0699129 (UMLS CUI [4])
drug photosensitivity
Item
history of photosensitivity reactions to other drugs
boolean
C0263586 (UMLS CUI [1])
pregnancy; lactating
Item
pregnant or nursing (lactating) woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
exclusion criteria
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C0680251 (UMLS CUI [1])