ID

39874

Description

Cardiac Safety Study in Patients With HER2 + Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01904903

Link

https://clinicaltrials.gov/show/NCT01904903

Keywords

Versions (1)
  1. 2/26/20 2/26/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 26, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility HER2 Positive Breast Cancer NCT01904903

English

Eligibility HER2 Positive Breast Cancer NCT01904903

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female or male patient diagnosed with stage i-iv breast cancer
Description

Gender | Breast Carcinoma TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0474926
her2 positive breast cancer, defined by immunohistochemical staining for her2 protein of 3+ intensity and/or amplification of the her2 gene on fluorescence in situ hybridization (fish) ≥ 2.0 on breast specimen or biopsy of a metastatic site
Description

HER2-positive carcinoma of breast | Specimen from breast HER2 protein Immunohistochemistry | Specimen from breast HER2 gene amplification Fluorescent in Situ Hybridization | Metastatic cancer site Biopsy

Data type

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2,1]
C0586519
UMLS CUI [2,2]
C1702024
UMLS CUI [2,3]
C0021044
UMLS CUI [3,1]
C0586519
UMLS CUI [3,2]
C1512127
UMLS CUI [3,3]
C0162789
UMLS CUI [4,1]
C0280457
UMLS CUI [4,2]
C0005558
lvef < 50% and ≥ 40% documented in echocardiogram done within the last 30 days
Description

Left ventricular ejection fraction Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
her2 therapy naïve or currently receiving non-lapatinib her2 targeted therapy
Description

Therapy naive HER2 gene | Targeted Therapy HER2 gene | Exception Lapatinib

Data type

boolean

Alias
UMLS CUI [1,1]
C0919936
UMLS CUI [1,2]
C0242957
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0242957
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1506770
patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation
Description

trastuzumab | Trastuzumab Planned | Pertuzumab/Trastuzumab Regimen | Pertuzumab/Trastuzumab Regimen Planned | Ado-trastuzumab emtansine | Ado-trastuzumab emtansine Planned | Combined Modality Therapy | Systemic therapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C1301732
UMLS CUI [3]
C4527348
UMLS CUI [4,1]
C4527348
UMLS CUI [4,2]
C1301732
UMLS CUI [5]
C2935436
UMLS CUI [6,1]
C2935436
UMLS CUI [6,2]
C1301732
UMLS CUI [7]
C0009429
UMLS CUI [8]
C1515119
UMLS CUI [9]
C1522449
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient is willing and able to comply with protocol required assessments and procedures
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous hospitalization due to documented heart failure in the last 12 months
Description

Hospitalization Due to Heart Failure Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C0205156
current signs or symptoms of heart failure or ischemia
Description

Sign or Symptom Heart failure | Sign or Symptom Ischemia

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0018801
UMLS CUI [2,1]
C3540840
UMLS CUI [2,2]
C0022116
history of arrhythmia requiring pharmacological or electrical treatment
Description

Cardiac Arrhythmia Requirement Pharmacotherapy | Cardiac Arrhythmia Requirement Electric Countershock

Data type

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013216
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0013778
concomitant use of anthracyclines or use of anthracyclines in the last 50 days
Description

Anthracyclines

Data type

boolean

Alias
UMLS CUI [1]
C0282564
pregnant or lactating patients. patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
UMLS CUI [5,1]
C3831118
UMLS CUI [5,2]
C0430061
history of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.
Description

Nervous system disorder Preventing Informed Consent | Mental disorders Preventing Informed Consent | Psychotic Disorders | Dementia

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
UMLS CUI [3]
C0033975
UMLS CUI [4]
C0497327
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Similar models

Eligibility HER2 Positive Breast Cancer NCT01904903

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Breast Carcinoma TNM Breast tumor staging
Item
female or male patient diagnosed with stage i-iv breast cancer
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
HER2-positive carcinoma of breast | Specimen from breast HER2 protein Immunohistochemistry | Specimen from breast HER2 gene amplification Fluorescent in Situ Hybridization | Metastatic cancer site Biopsy
Item
her2 positive breast cancer, defined by immunohistochemical staining for her2 protein of 3+ intensity and/or amplification of the her2 gene on fluorescence in situ hybridization (fish) ≥ 2.0 on breast specimen or biopsy of a metastatic site
boolean
C1960398 (UMLS CUI [1])
C0586519 (UMLS CUI [2,1])
C1702024 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0586519 (UMLS CUI [3,1])
C1512127 (UMLS CUI [3,2])
C0162789 (UMLS CUI [3,3])
C0280457 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Left ventricular ejection fraction Echocardiography
Item
lvef < 50% and ≥ 40% documented in echocardiogram done within the last 30 days
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
Therapy naive HER2 gene | Targeted Therapy HER2 gene | Exception Lapatinib
Item
her2 therapy naïve or currently receiving non-lapatinib her2 targeted therapy
boolean
C0919936 (UMLS CUI [1,1])
C0242957 (UMLS CUI [1,2])
C2985566 (UMLS CUI [2,1])
C0242957 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1506770 (UMLS CUI [3,2])
trastuzumab | Trastuzumab Planned | Pertuzumab/Trastuzumab Regimen | Pertuzumab/Trastuzumab Regimen Planned | Ado-trastuzumab emtansine | Ado-trastuzumab emtansine Planned | Combined Modality Therapy | Systemic therapy | Therapeutic radiology procedure
Item
patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least 3 months, alone or in combination with other systemic treatment or radiation
boolean
C0728747 (UMLS CUI [1])
C0728747 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C4527348 (UMLS CUI [3])
C4527348 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C2935436 (UMLS CUI [5])
C2935436 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
C0009429 (UMLS CUI [7])
C1515119 (UMLS CUI [8])
C1522449 (UMLS CUI [9])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance
Item
patient is willing and able to comply with protocol required assessments and procedures
boolean
C0525058 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hospitalization Due to Heart Failure Previous
Item
previous hospitalization due to documented heart failure in the last 12 months
boolean
C3898876 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Sign or Symptom Heart failure | Sign or Symptom Ischemia
Item
current signs or symptoms of heart failure or ischemia
boolean
C3540840 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0022116 (UMLS CUI [2,2])
Cardiac Arrhythmia Requirement Pharmacotherapy | Cardiac Arrhythmia Requirement Electric Countershock
Item
history of arrhythmia requiring pharmacological or electrical treatment
boolean
C0003811 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013216 (UMLS CUI [1,3])
C0003811 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0013778 (UMLS CUI [2,3])
Anthracyclines
Item
concomitant use of anthracyclines or use of anthracyclines in the last 50 days
boolean
C0282564 (UMLS CUI [1])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
pregnant or lactating patients. patients of childbearing potential must implement contraceptive measures during study treatment and for 7 months after last dose of treatment drug and must have negative urine or serum pregnancy test within 7 days prior to registration.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C3831118 (UMLS CUI [5,1])
C0430061 (UMLS CUI [5,2])
Nervous system disorder Preventing Informed Consent | Mental disorders Preventing Informed Consent | Psychotic Disorders | Dementia
Item
history of significant neurologic or psychiatric disorders including psychotic disorders or dementia that would prohibit the understanding and giving of informed consent.
boolean
C0027765 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0033975 (UMLS CUI [3])
C0497327 (UMLS CUI [4])
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