ID

35025

Beschrijving

Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen; ODM derived from: https://clinicaltrials.gov/show/NCT02419742

Link

https://clinicaltrials.gov/show/NCT02419742

Trefwoorden

Versies (1)
  1. 10-02-19 10-02-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

10 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02419742

Engels

Eligibility Breast Cancer NCT02419742

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed early invasive her2 positive, node positive or high risk node negative breast cancer with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage i to iiia that is eligible for adjuvant treatment with trastuzumab.
Beschrijving

Early-Stage Breast Carcinoma HER2 Positive Invasive | Node-positive breast cancer | High risk Node-negative breast cancer | Residual Tumor Absent | Recurrent disease Locally Absent | Locally Metastatic Malignant Neoplasm Absent | Breast Carcinoma TNM Breast tumor staging | Eligibility Trastuzumab Adjuvant therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C2986665
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C0205281
UMLS CUI [2]
C3160887
UMLS CUI [3,1]
C4319571
UMLS CUI [3,2]
C3160889
UMLS CUI [4,1]
C0543478
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C1517927
UMLS CUI [5,3]
C0332197
UMLS CUI [6,1]
C1334411
UMLS CUI [6,2]
C0332197
UMLS CUI [7,1]
C0678222
UMLS CUI [7,2]
C0474926
UMLS CUI [8,1]
C1548635
UMLS CUI [8,2]
C0728747
UMLS CUI [8,3]
C0677850
eastern cooperative oncology group (ecog) performance status 0 to 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
her2 over-expression/amplification defined as either ihc3+, or ihc2+ and fluorescence in situ hybridization (fish) positive as determined in a central laboratory.
Beschrijving

HER2 Overexpression | HER2 gene amplification | Immunohistochemistry Positive | FISH Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [2]
C1512127
UMLS CUI [3,1]
C0021044
UMLS CUI [3,2]
C1514241
UMLS CUI [4,1]
C0162789
UMLS CUI [4,2]
C1514241
at time of starting trastuzumab therapy, left ventricular ejection fraction (lvef) measured by echocardiography.
Beschrijving

trastuzumab | Left ventricular ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
screening left ventricular ejection fraction (lvef) =/> 55%.
Beschrijving

Left ventricular ejection fraction Screening

Datatype

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0220908
adequate bone marrow, renal, and hepatic function.
Beschrijving

Bone Marrow function | Renal function | Liver function

Datatype

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential.
Beschrijving

Childbearing Potential Contraceptive methods | Exception Hormonal contraception

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2985296
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any contraindication to trastuzumab.
Beschrijving

Medical contraindication Trastuzumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728747
previous adjuvant breast cancer treatment with an approved or investigational anti-her2 agent.
Beschrijving

Adjuvant therapy Breast Carcinoma | Anti-HER2 Antibody

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677850
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C4329777
history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies who have been disease-free for at least 5 years.
Beschrijving

Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C1707251
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
past history of ductal carcinoma in situ and/or lobular carcinoma that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops.
Beschrijving

Systemic therapy Ductal carcinoma in situ | Systemic therapy Lobular Carcinoma | Radiotherapy to breast Ipsilateral | Invasive cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0007124
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0206692
UMLS CUI [3,1]
C0948310
UMLS CUI [3,2]
C0441989
UMLS CUI [4]
C0677898
locally advanced (stage iiib and iiic) and metastatic disease (stage iv).
Beschrijving

Locally Advanced Malignant Neoplasm TNM clinical staging | Neoplasm Metastasis TNM clinical staging

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677984
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C3258246
clinically relevant cardiovascular disorder or disease.
Beschrijving

Cardiovascular Disease

Datatype

boolean

Alias
UMLS CUI [1]
C0007222
uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy.
Beschrijving

Uncontrolled hypertension | Hypertensive crisis | Hypertensive Encephalopathy

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0020546
UMLS CUI [3]
C0151620
history of severe allergic or immunological reactions, e.g. difficult to control asthma.
Beschrijving

Severe allergy | Immunologic reaction Severe | Asthma Control Difficult

Datatype

boolean

Alias
UMLS CUI [1]
C2945656
UMLS CUI [2,1]
C0301873
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0004096
UMLS CUI [3,2]
C2587213
UMLS CUI [3,3]
C0332218
pregnant or lactating women.
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02419742

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Early-Stage Breast Carcinoma HER2 Positive Invasive | Node-positive breast cancer | High risk Node-negative breast cancer | Residual Tumor Absent | Recurrent disease Locally Absent | Locally Metastatic Malignant Neoplasm Absent | Breast Carcinoma TNM Breast tumor staging | Eligibility Trastuzumab Adjuvant therapy
Item
histologically confirmed early invasive her2 positive, node positive or high risk node negative breast cancer with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage i to iiia that is eligible for adjuvant treatment with trastuzumab.
boolean
C2986665 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0205281 (UMLS CUI [1,3])
C3160887 (UMLS CUI [2])
C4319571 (UMLS CUI [3,1])
C3160889 (UMLS CUI [3,2])
C0543478 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0277556 (UMLS CUI [5,1])
C1517927 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
C1334411 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0678222 (UMLS CUI [7,1])
C0474926 (UMLS CUI [7,2])
C1548635 (UMLS CUI [8,1])
C0728747 (UMLS CUI [8,2])
C0677850 (UMLS CUI [8,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 to 2.
boolean
C1520224 (UMLS CUI [1])
HER2 Overexpression | HER2 gene amplification | Immunohistochemistry Positive | FISH Positive
Item
her2 over-expression/amplification defined as either ihc3+, or ihc2+ and fluorescence in situ hybridization (fish) positive as determined in a central laboratory.
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2])
C0021044 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
C0162789 (UMLS CUI [4,1])
C1514241 (UMLS CUI [4,2])
trastuzumab | Left ventricular ejection fraction Echocardiography
Item
at time of starting trastuzumab therapy, left ventricular ejection fraction (lvef) measured by echocardiography.
boolean
C0728747 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Left ventricular ejection fraction Screening
Item
screening left ventricular ejection fraction (lvef) =/> 55%.
boolean
C0428772 (UMLS CUI [1,1])
C0220908 (UMLS CUI [1,2])
Bone Marrow function | Renal function | Liver function
Item
adequate bone marrow, renal, and hepatic function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Childbearing Potential Contraceptive methods | Exception Hormonal contraception
Item
agreement to use an adequate, non-hormonal means of contraception by women of childbearing potential.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Trastuzumab
Item
any contraindication to trastuzumab.
boolean
C1301624 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Adjuvant therapy Breast Carcinoma | Anti-HER2 Antibody
Item
previous adjuvant breast cancer treatment with an approved or investigational anti-her2 agent.
boolean
C0677850 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C4329777 (UMLS CUI [2])
Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration
Item
history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies who have been disease-free for at least 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Systemic therapy Ductal carcinoma in situ | Systemic therapy Lobular Carcinoma | Radiotherapy to breast Ipsilateral | Invasive cancer
Item
past history of ductal carcinoma in situ and/or lobular carcinoma that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops.
boolean
C1515119 (UMLS CUI [1,1])
C0007124 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0206692 (UMLS CUI [2,2])
C0948310 (UMLS CUI [3,1])
C0441989 (UMLS CUI [3,2])
C0677898 (UMLS CUI [4])
Locally Advanced Malignant Neoplasm TNM clinical staging | Neoplasm Metastasis TNM clinical staging
Item
locally advanced (stage iiib and iiic) and metastatic disease (stage iv).
boolean
C0677984 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
Cardiovascular Disease
Item
clinically relevant cardiovascular disorder or disease.
boolean
C0007222 (UMLS CUI [1])
Uncontrolled hypertension | Hypertensive crisis | Hypertensive Encephalopathy
Item
uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy.
boolean
C1868885 (UMLS CUI [1])
C0020546 (UMLS CUI [2])
C0151620 (UMLS CUI [3])
Severe allergy | Immunologic reaction Severe | Asthma Control Difficult
Item
history of severe allergic or immunological reactions, e.g. difficult to control asthma.
boolean
C2945656 (UMLS CUI [1])
C0301873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0004096 (UMLS CUI [3,1])
C2587213 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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