ID

38170

Descrição

A Study of Subcutaneously Administered Herceptin (Trastuzumab) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01928615

Link

https://clinicaltrials.gov/show/NCT01928615

Palavras-chave

Versões (1)
  1. 24/09/2019 24/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

24 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01928615

Inglês

Eligibility Breast Cancer NCT01928615

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female and male patients ≥ years of age.
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
her2-positive early breast cancer.
Descrição

Early-Stage Breast Carcinoma HER2 Positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2986665
UMLS CUI [1,2]
C2348909
eastern cooperative oncology group (ecog) performance status 0-1.
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
hormonal therapy will be allowed as per institutional guidelines.
Descrição

Hormone Therapy allowed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C0683607
patients must be herceptin (trastuzumab) naïve.
Descrição

Herceptin Absent | Trastuzumab Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0338204
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0332197
left ventricular ejection fraction (lvef) of ≥ 55%.
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast.
Descrição

Breast adenocarcinoma Invasive | Neoplasm Metastasis Absent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant).
Descrição

Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Status post Operative Surgical Procedure Completion | Status post Chemotherapy Completion | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0543478
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0543467
UMLS CUI [4,3]
C0205197
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0392920
UMLS CUI [5,3]
C0205197
UMLS CUI [6,1]
C0600558
UMLS CUI [6,2]
C3665472
UMLS CUI [7]
C0085533
use of concurrent curative radiotherapy will be permitted.
Descrição

Therapeutic radiology procedure Curative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1276305
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of other malignancy which could affect compliance with the protocol or interpretation of results. patients with 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, are eligible.
Descrição

Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1707251
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C1707251
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0459471
UMLS CUI [2,4]
C0683954
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C1707251
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
patients with severe dyspnea at rest or requiring supplementary oxygen therapy.
Descrição

Resting Dyspnea Severe | Oxygen supplementation Required

Tipo de dados

boolean

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

Comorbidity Serious Interferes with Planned Treatment | Lung diseases Severe

Tipo de dados

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 herceptin, specifically, a 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), or diagnosed poorly controlled hypertension.
Descrição

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

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0338204
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0332196
UMLS CUI [2,4]
C0338204
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C4319571
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
pregnant or lactating women.
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing potential and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment.
Descrição

Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Gender Partner in relationship Childbearing Potential | Contraceptive methods Unable | Contraceptive methods Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0558080
UMLS CUI [3,1]
C0079399
UMLS CUI [3,2]
C0682323
UMLS CUI [3,3]
C3831118
UMLS CUI [4,1]
C0700589
UMLS CUI [4,2]
C1299582
UMLS CUI [5,1]
C0700589
UMLS CUI [5,2]
C0558080
concurrent enrollment 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.
Descrição

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

Tipo de dados

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 a history of severe allergic or immunological reactions, eg, difficult to control asthma.
Descrição

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

Tipo de dados

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]
C2220378
UMLS CUI [6,1]
C0301873
UMLS CUI [6,2]
C0205082
UMLS CUI [7,1]
C0332218
UMLS CUI [7,2]
C0004096
UMLS CUI [7,3]
C2587213
inadequate bone marrow, hepatic, or renal function.
Descrição

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

Tipo de dados

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
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Similar models

Eligibility Breast Cancer NCT01928615

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
female and male patients ≥ years of age.
boolean
C0001779 (UMLS CUI [1])
Early-Stage Breast Carcinoma HER2 Positive
Item
her2-positive early breast cancer.
boolean
C2986665 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1.
boolean
C1520224 (UMLS CUI [1])
Hormone Therapy allowed
Item
hormonal therapy will be allowed as per institutional guidelines.
boolean
C0279025 (UMLS CUI [1,1])
C0683607 (UMLS CUI [1,2])
Herceptin Absent | Trastuzumab Absent
Item
patients must be herceptin (trastuzumab) naïve.
boolean
C0338204 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) of ≥ 55%.
boolean
C0428772 (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])
Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Status post Operative Surgical Procedure Completion | Status post Chemotherapy Completion | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant
Item
no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant).
boolean
C0543478 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
C0600558 (UMLS CUI [6,1])
C3665472 (UMLS CUI [6,2])
C0085533 (UMLS CUI [7])
Therapeutic radiology procedure Curative
Item
use of concurrent curative radiotherapy will be permitted.
boolean
C1522449 (UMLS CUI [1,1])
C1276305 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Cancer Other Affecting Protocol Compliance | Cancer Other Affecting Interpretation Research results | 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 which could affect compliance with the protocol or interpretation of results. patients with 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, are eligible.
boolean
C1707251 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C1707251 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0459471 (UMLS CUI [2,3])
C0683954 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
Resting Dyspnea Severe | Oxygen supplementation Required
Item
patients with severe dyspnea at rest or requiring supplementary oxygen therapy.
boolean
C0743330 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0919655 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Comorbidity Serious Interferes with Planned Treatment | Lung diseases Severe
Item
patients with other 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 Excludes Herceptin | Medical condition Serious Excludes Herceptin | Congestive heart failure | High risk 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 herceptin, specifically, a 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), or diagnosed poorly controlled hypertension.
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0338204 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0338204 (UMLS CUI [2,4])
C0018802 (UMLS CUI [3])
C4319571 (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])
Pregnancy | Breast Feeding
Item
pregnant or lactating women.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Contraceptive methods Unable | Childbearing Potential Contraceptive methods Unwilling | Gender Partner in relationship Childbearing Potential | Contraceptive methods Unable | Contraceptive methods Unwilling
Item
women of childbearing potential and male patients with partners of childbearing potential who are unable or unwilling to use adequate contraceptive measures during study treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0079399 (UMLS CUI [3,1])
C0682323 (UMLS CUI [3,2])
C3831118 (UMLS CUI [3,3])
C0700589 (UMLS CUI [4,1])
C1299582 (UMLS CUI [4,2])
C0700589 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
Study Subject Participation Status | Cancer treatment Investigational | Hormone Therapy | Diphosphonates | Immunotherapy
Item
concurrent enrollment 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 | 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 a history of severe allergic or immunological reactions, eg, difficult 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])
C2220378 (UMLS CUI [5])
C0301873 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0332218 (UMLS CUI [7,1])
C0004096 (UMLS CUI [7,2])
C2587213 (UMLS CUI [7,3])
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])
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