ID

38213

Description

SCHEARLY Study: A Study of the Safety of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Early and Locally Advanced HER2-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01940497

Link

https://clinicaltrials.gov/show/NCT01940497

Keywords

Versions (1)
  1. 9/28/19 9/28/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 28, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01940497

English

Eligibility Breast Cancer NCT01940497

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male patients, >/= 18 years of age
Description

Age

Data type

boolean

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

Breast adenocarcinoma Invasive | Neoplasm Metastasis Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
her2-positive disease immunohistochemistry (ihc) 3+ or in situ hybridization (ish) positive
Description

Disease HER2 Positive Immunohistochemistry | Disease HER2 Positive In Situ Hybridization Staining Method

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348909
UMLS CUI [2,3]
C3853647
eastern cooperative oncology group (ecog) performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction (lvef) of >/= 55% prior to first dose of trastuzumab sc
Description

Left ventricular ejection fraction | Status pre- Trastuzumab Subcutaneous

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C0728747
UMLS CUI [2,3]
C1522438
intact skin at site of sc injection on the thigh
Description

Intact skin | Thigh Site Subcutaneous Injection

Data type

boolean

Alias
UMLS CUI [1]
C2712179
UMLS CUI [2,1]
C0039866
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0021499
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of other malignancy, except for patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
Description

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

Data type

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
severe dyspnea at rest or requiring supplementary oxygen therapy
Description

Resting Dyspnea Severe | Requirement Oxygen supplementation

Data type

boolean

Alias
UMLS CUI [1,1]
C0743330
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0919655
concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
Description

Comorbidity Serious Interferes with Planned Treatment | Lung diseases Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C3641097
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205082
serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (chf), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ecg), diagnosed poorly controlled hypertension
Description

Heart Disease Serious | Medical condition Excludes Trastuzumab | Congestive heart failure | High risk of Cardiac Arrhythmia Uncontrolled | Angina Pectoris Requirement Pharmaceutical Preparations | Valvular disease | Transmural myocardial infarction Electrocardiography | Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0728747
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0332167
UMLS CUI [4,2]
C0003811
UMLS CUI [4,3]
C0205318
UMLS CUI [5,1]
C0002962
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0013227
UMLS CUI [6]
C3258293
UMLS CUI [7,1]
C1400513
UMLS CUI [7,2]
C1623258
UMLS CUI [8]
C0421190
known infection with human immunodeficiency virus (hiv), active hepatitis b virus (hbv) or hepatitis c virus (hcv)
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Description

Study Subject Participation Status | Cancer treatment Investigational | Hormone Therapy | Diphosphonates | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C1517586
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0012544
UMLS CUI [5]
C0021083
known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of herceptin including hyaluronidase, or the adhesive of the sc device (for cohort b), or a history of severe allergic or immunological reactions, e.g. difficulty to control asthma
Description

Hypersensitivity Trastuzumab | Hypersensitivity Murine protein | Hypersensitivity Herceptin Excipient | Hyaluronidase allergy | Hypersensitivity Adhesive Device | Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1699668
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0338204
UMLS CUI [3,3]
C0015237
UMLS CUI [4]
C0572015
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0001516
UMLS CUI [5,3]
C0025080
UMLS CUI [6]
C2220378
UMLS CUI [7,1]
C0301873
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0332218
UMLS CUI [8,2]
C0004096
UMLS CUI [8,3]
C2587213
inadequate bone marrow, hepatic or renal function
Description

Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205412
pre-existing motor or sensory neuropathy of grade > 1
Description

Motor neuropathy Pre-existing CTCAE Grades | Sensory neuropathy Pre-existing CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0235025
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C1516728
UMLS CUI [2,1]
C0151313
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C1516728
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Similar models

Eligibility Breast Cancer NCT01940497

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
female and male patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma Invasive | Neoplasm Metastasis Absent
Item
histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Disease HER2 Positive Immunohistochemistry | Disease HER2 Positive In Situ Hybridization Staining Method
Item
her2-positive disease immunohistochemistry (ihc) 3+ or in situ hybridization (ish) positive
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C3853647 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction | Status pre- Trastuzumab Subcutaneous
Item
left ventricular ejection fraction (lvef) of >/= 55% prior to first dose of trastuzumab sc
boolean
C0428772 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1522438 (UMLS CUI [2,3])
Intact skin | Thigh Site Subcutaneous Injection
Item
intact skin at site of sc injection on the thigh
boolean
C2712179 (UMLS CUI [1])
C0039866 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0021499 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
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 patients with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, 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])
Resting Dyspnea Severe | Requirement Oxygen supplementation
Item
severe dyspnea at rest or requiring supplementary oxygen therapy
boolean
C0743330 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0919655 (UMLS CUI [2,2])
Comorbidity Serious Interferes with Planned Treatment | Lung diseases Severe
Item
concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C3641097 (UMLS CUI [1,4])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Heart Disease Serious | Medical condition Excludes Trastuzumab | Congestive heart failure | High risk of Cardiac Arrhythmia Uncontrolled | Angina Pectoris Requirement Pharmaceutical Preparations | Valvular disease | Transmural myocardial infarction Electrocardiography | Poor hypertension control
Item
serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (chf), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ecg), diagnosed poorly controlled hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0728747 (UMLS CUI [2,3])
C0018802 (UMLS CUI [3])
C0332167 (UMLS CUI [4,1])
C0003811 (UMLS CUI [4,2])
C0205318 (UMLS CUI [4,3])
C0002962 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
C3258293 (UMLS CUI [6])
C1400513 (UMLS CUI [7,1])
C1623258 (UMLS CUI [7,2])
C0421190 (UMLS CUI [8])
HIV Infection | Hepatitis B | Hepatitis C
Item
known infection with human immunodeficiency virus (hiv), active hepatitis b virus (hbv) or hepatitis c virus (hcv)
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Cancer treatment Investigational | Hormone Therapy | Diphosphonates | Immunotherapy
Item
concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
boolean
C2348568 (UMLS CUI [1])
C0920425 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3])
C0012544 (UMLS CUI [4])
C0021083 (UMLS CUI [5])
Hypersensitivity Trastuzumab | Hypersensitivity Murine protein | Hypersensitivity Herceptin Excipient | Hyaluronidase allergy | Hypersensitivity Adhesive Device | Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control
Item
known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of herceptin including hyaluronidase, or the adhesive of the sc device (for cohort b), or a history of severe allergic or immunological reactions, e.g. difficulty to control asthma
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0572015 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0001516 (UMLS CUI [5,2])
C0025080 (UMLS CUI [5,3])
C2220378 (UMLS CUI [6])
C0301873 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0332218 (UMLS CUI [8,1])
C0004096 (UMLS CUI [8,2])
C2587213 (UMLS CUI [8,3])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, hepatic or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Motor neuropathy Pre-existing CTCAE Grades | Sensory neuropathy Pre-existing CTCAE Grades
Item
pre-existing motor or sensory neuropathy of grade > 1
boolean
C0235025 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
C0151313 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
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