ID

38200

Description

Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification; ODM derived from: https://clinicaltrials.gov/show/NCT02177175

Link

https://clinicaltrials.gov/show/NCT02177175

Keywords

Versions (2)
  1. 9/26/19 9/26/19 -
  2. 9/26/19 9/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02177175

English

Eligibility Breast Cancer NCT02177175

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
age ≥ 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
non-metastatic histologically confirmed primary invasive breast carcinoma
Description

Invasive carcinoma of breast | Neoplasm Metastasis Absent

Data type

boolean

Alias
UMLS CUI [1]
C0853879
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
pathologically confirmed her2-positive breast cancer
Description

HER2-positive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C1960398
scheduled to receive anthracycline chemotherapy followed by anti-her2 therapy at mskcc
Description

Chemotherapy Scheduled | Anthracyclines | HER2 Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205539
UMLS CUI [2]
C0282564
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C2985566
able and willing to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
willing and able to comply with the requirements of the protocol
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
able to swallow capsules
Description

Able to swallow capsules

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0006935
for aim 2, all patients must meet the following criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
meet all inclusion criteria above
Description

Inclusion criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1550543
lvef > 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-her2 therapy
Description

Longitudinal strain rate.diastole.max Abnormal | Longitudinal strain rate.systole.max Abnormal | Status pre- HER2 Targeted Therapy Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C4263402
UMLS CUI [1,2]
C0205161
UMLS CUI [2,1]
C4263410
UMLS CUI [2,2]
C0205161
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0069515
UMLS CUI [3,3]
C2985566
UMLS CUI [3,4]
C1301732
heart rate ≥ 50 beats per minute
Description

Heart rate

Data type

boolean

Alias
UMLS CUI [1]
C0018810
sitting systolic blood pressure > 90 mmhg
Description

Sitting systolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1319893
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients are to be excluded from randomization for aim 2 of this study if they meet any of the following criteria:
Description

Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
current treatment with ace-inhibitors or beta blockers
Description

Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists

Data type

boolean

Alias
UMLS CUI [1]
C0003015
UMLS CUI [2]
C0304516
allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or av block.
Description

Beta-blocker allergy | Adrenergic beta-1 Receptor Antagonists Receive Unable | Etiology Bradycardia | Etiology Hypotension | Etiology Atrioventricular Block

Data type

boolean

Alias
UMLS CUI [1]
C0570882
UMLS CUI [2,1]
C0304516
UMLS CUI [2,2]
C1514756
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0428977
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0020649
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0004245
known history of nci ctcae (version 4.0) grade ≥ 2 symptomatic chf, myocardial infarction within 12 months prior to randomization, significant symptoms (grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade ≥ 3)
Description

Symptomatic congestive heart failure CTCAE Grades | Myocardial Infarction | Symptoms CTCAE Grades | Relationship Left Ventricular Dysfunction | Valvular disease Moderate | Valvular disease Severe | Cardiac Arrhythmia CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0742758
UMLS CUI [1,2]
C1516728
UMLS CUI [2]
C0027051
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C1516728
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0242698
UMLS CUI [5,1]
C3258293
UMLS CUI [5,2]
C0205081
UMLS CUI [6,1]
C3258293
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C1516728
pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
Description

Premenopausal state Serum pregnancy test negative Absent | Premenopausal state Urine pregnancy test negative Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0232969
UMLS CUI [1,2]
C0430061
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0232969
UMLS CUI [2,2]
C0430057
UMLS CUI [2,3]
C0332197
already enrolled in a breast cancer medicine therapeutic intervention trial
Description

Study Subject Participation Status | Clinical Trial Breast Carcinoma Interventional procedure

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0678222
UMLS CUI [2,3]
C0184661
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Similar models

Eligibility Breast Cancer NCT02177175

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
female
boolean
C0079399 (UMLS CUI [1])
Age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Invasive carcinoma of breast | Neoplasm Metastasis Absent
Item
non-metastatic histologically confirmed primary invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
HER2-positive carcinoma of breast
Item
pathologically confirmed her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
Chemotherapy Scheduled | Anthracyclines | HER2 Targeted Therapy
Item
scheduled to receive anthracycline chemotherapy followed by anti-her2 therapy at mskcc
boolean
C0392920 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
Informed Consent
Item
able and willing to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing and able to comply with the requirements of the protocol
boolean
C0525058 (UMLS CUI [1])
Able to swallow capsules
Item
able to swallow capsules
boolean
C2712086 (UMLS CUI [1,1])
C0006935 (UMLS CUI [1,2])
Criteria Fulfill
Item
for aim 2, all patients must meet the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Inclusion criteria Fulfill
Item
meet all inclusion criteria above
boolean
C1512693 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
lvef > 50%
boolean
C0428772 (UMLS CUI [1])
Longitudinal strain rate.diastole.max Abnormal | Longitudinal strain rate.systole.max Abnormal | Status pre- HER2 Targeted Therapy Planned
Item
abnormal global longitudinal strain (<19%, or a % decrease of ≥ 11% from baseline) prior to initiation of planned anti-her2 therapy
boolean
C4263402 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C4263410 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C2985566 (UMLS CUI [3,3])
C1301732 (UMLS CUI [3,4])
Heart rate
Item
heart rate ≥ 50 beats per minute
boolean
C0018810 (UMLS CUI [1])
Sitting systolic blood pressure
Item
sitting systolic blood pressure > 90 mmhg
boolean
C1319893 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
patients are to be excluded from randomization for aim 2 of this study if they meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Angiotensin-Converting Enzyme Inhibitors | Adrenergic beta-1 Receptor Antagonists
Item
current treatment with ace-inhibitors or beta blockers
boolean
C0003015 (UMLS CUI [1])
C0304516 (UMLS CUI [2])
Beta-blocker allergy | Adrenergic beta-1 Receptor Antagonists Receive Unable | Etiology Bradycardia | Etiology Hypotension | Etiology Atrioventricular Block
Item
allergies or inability to tolerate beta blockers previously due to bradycardia, hypotension, or av block.
boolean
C0570882 (UMLS CUI [1])
C0304516 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0428977 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C0020649 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0004245 (UMLS CUI [5,2])
Symptomatic congestive heart failure CTCAE Grades | Myocardial Infarction | Symptoms CTCAE Grades | Relationship Left Ventricular Dysfunction | Valvular disease Moderate | Valvular disease Severe | Cardiac Arrhythmia CTCAE Grades
Item
known history of nci ctcae (version 4.0) grade ≥ 2 symptomatic chf, myocardial infarction within 12 months prior to randomization, significant symptoms (grade ≥ 3) relating to left ventricular dysfunction, significant (moderate or severe) valvular disease, or significant cardiac arrhythmia (grade ≥ 3)
boolean
C0742758 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C1457887 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
C0439849 (UMLS CUI [4,1])
C0242698 (UMLS CUI [4,2])
C3258293 (UMLS CUI [5,1])
C0205081 (UMLS CUI [5,2])
C3258293 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0003811 (UMLS CUI [7,1])
C1516728 (UMLS CUI [7,2])
Premenopausal state Serum pregnancy test negative Absent | Premenopausal state Urine pregnancy test negative Absent
Item
pre-menopausal women without a negative serum or urine pregnancy test within 4 weeks of starting treatment
boolean
C0232969 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0232969 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trial Breast Carcinoma Interventional procedure
Item
already enrolled in a breast cancer medicine therapeutic intervention trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
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