Informações:
Falhas:
ID
38328
Descrição
Phase I Trial of Afatinib and Trastuzumab in HER2 Overexpressing Cancer.; ODM derived from: https://clinicaltrials.gov/show/NCT01649271
Link
https://clinicaltrials.gov/show/NCT01649271
Palavras-chave
Versões (1)
- 10/10/2019 10/10/2019 -
Titular dos direitos
See clinicaltrials.gov
Transferido a
10 de outubro de 2019
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01649271
Eligibility Breast Neoplasms NCT01649271
- StudyEvent: Eligibility
Similar models
Eligibility Breast Neoplasms NCT01649271
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
1. patients aged 18 years and older
boolean
C0001779 (UMLS CUI [1])
Neoplasm HER2 Overexpression Immunohistochemistry
Item
2. patients with cancers overexpressing her2 by immunohistochemistry test( ihc) 3+
boolean
C0027651 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
C0069515 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
Immunohistochemistry | HER2 gene amplification Positive FISH | Confirmation Tumor tissue sample
Item
and/or ihc 2+ with positive gene amplification by fish (confirmation on archived tissue needed)
boolean
C0021044 (UMLS CUI [1])
C1512127 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C0750484 (UMLS CUI [3,1])
C0475358 (UMLS CUI [3,2])
C1512127 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C0750484 (UMLS CUI [3,1])
C0475358 (UMLS CUI [3,2])
Informed Consent
Item
3. written informed consent that is consistent with ich-gcp guidelines.
boolean
C0021430 (UMLS CUI [1])
Patient Eligible Trastuzumab
Item
4. patients must be eligible for treatment with trastuzumab.
boolean
C0030705 (UMLS CUI [1,1])
C1548635 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
C1548635 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
Organ function | Renal function | Liver function | Bone Marrow function | Cardiac function
Item
5. patients must have adequate organ function (kidney, liver, bone marrow, cardiac)
boolean
C0678852 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C0232164 (UMLS CUI [5])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
C0005953 (UMLS CUI [4,1])
C0031843 (UMLS CUI [4,2])
C0232164 (UMLS CUI [5])
ECOG performance status
Item
6. eastern cooperative oncology group (ecog) = 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
7. measurable disease according to recist 1.1 (phase ib).
boolean
C1513041 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
1. active brain metastases.
boolean
C0220650 (UMLS CUI [1])
Targeted Therapy ErbB Receptors | Exception Trastuzumab | Exception Lapatinib
Item
2. prior treatment with erbb family targeting therapies within the past four weeks before start of therapy or concomitantly with the trial other than trastuzumab and/or lapatinib.
boolean
C2985566 (UMLS CUI [1,1])
C3812393 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1506770 (UMLS CUI [3,2])
C3812393 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1506770 (UMLS CUI [3,2])
Chemotherapy Quantity Secondary malignant neoplasm of female breast
Item
3. patients having more than 2 lines of chemotherapy for the treatment of metastatic breast cancer (phase ib).
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])