ID

34959

Beskrivning

A Study of Subcutaneous Herceptin (Trastuzumab) Administered at Home By Single-Use Injection Device in Patients With Early HER2-Positive Breast Cancer (HOMERUS); ODM derived from: https://clinicaltrials.gov/show/NCT02040935

Länk

https://clinicaltrials.gov/show/NCT02040935

Nyckelord

Versioner (1)
  1. 2019-02-05 2019-02-05 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

5 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02040935

Engelsk

Eligibility Breast Cancer NCT02040935

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

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

Breast adenocarcinoma Invasive Primary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0205225
her2-positive disease
Beskrivning

Disease HER2 Positive

Datatyp

boolean

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

ECOG performance status

Datatyp

boolean

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

Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0279025
prior use of anti-her2 therapy will be allowed except for early breast cancer patients in the neo-adjuvant setting
Beskrivning

Prior Therapy Against HER2 | Exception Neoadjuvant Therapy Early-Stage Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0069515
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0600558
UMLS CUI [2,3]
C2986665
left ventricular ejection fraction >/= 55%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
no evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
Beskrivning

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

Datatyp

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]
C0392920
UMLS CUI [6,2]
C0600558
UMLS CUI [7]
C0085533
use of concurrent radiotherapy will be permitted
Beskrivning

Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C1522449
completion of surgery and chemotherapy (if applicable) for early breast cancer
Beskrivning

Operative Surgical Procedures Completion Early-Stage Breast Carcinoma | Chemotherapy Completion Early-Stage Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C2986665
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C2986665
Exclusion Criteria
Beskrivning

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 who have been disease-free for the last 5 years
Beskrivning

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

Datatyp

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]
C0006826
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
patients with severe dyspnea at rest or requiring supplementary oxygen therapy
Beskrivning

Resting Dyspnea Severe | Severe dyspnea requiring oxygen supplement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0743330
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C2080706
patients with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
Beskrivning

Comorbidity Serious Interferes with Therapeutic procedure | Lung disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0087111
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, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on ecg, poorly controlled hypertension
Beskrivning

Heart Disease Excludes Trastuzumab | Medical condition Excludes Trastuzumab | Congestive heart failure | High risk Cardiac Arrhythmia Uncontrolled | Angina Pectoris Requiring Pharmaceutical Preparations | Valvular disease | Transmural infarct ECG | Poor hypertension control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C0728747
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0728747
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]
C0333561
UMLS CUI [7,2]
C0013798
UMLS CUI [8]
C0421190
pregnant or lactating women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

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

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

Datatyp

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 enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Beskrivning

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

Datatyp

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 excipients of herceptin including hyaluronidase, or the adhesive of the sc device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
Beskrivning

Hypersensitivity Trastuzumab | Hypersensitivity Murine protein | Hypersensitivity Herceptin Pharmaceutical Excipient | Hyaluronidase allergy | Hypersensitivity Adhesives | Severe allergy | Immunologic reaction Severe | Asthma Control Difficult

Datatyp

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 [6]
C2945656
UMLS CUI [7,1]
C0301873
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0004096
UMLS CUI [8,2]
C0243148
UMLS CUI [8,3]
C0332218
inadequate bone marrow, hepatic or renal function
Beskrivning

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

Datatyp

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 NCT02040935

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
female and male patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Breast adenocarcinoma Invasive Primary
Item
histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Disease HER2 Positive
Item
her2-positive disease
boolean
C0012634 (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
Item
hormonal therapy will be allowed as per institutional guidelines
boolean
C0279025 (UMLS CUI [1])
Prior Therapy Against HER2 | Exception Neoadjuvant Therapy Early-Stage Breast Carcinoma
Item
prior use of anti-her2 therapy will be allowed except for early breast cancer patients in the neo-adjuvant setting
boolean
C1514463 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C2986665 (UMLS CUI [2,3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction >/= 55%
boolean
C0428772 (UMLS CUI [1])
Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Status post Operative Surgical Procedures Completion | Status post Chemotherapy Completion | Chemotherapy Neoadjuvant | 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])
C0392920 (UMLS CUI [6,1])
C0600558 (UMLS CUI [6,2])
C0085533 (UMLS CUI [7])
Therapeutic radiology procedure
Item
use of concurrent radiotherapy will be permitted
boolean
C1522449 (UMLS CUI [1])
Operative Surgical Procedures Completion Early-Stage Breast Carcinoma | Chemotherapy Completion Early-Stage Breast Carcinoma
Item
completion of surgery and chemotherapy (if applicable) for early breast cancer
boolean
C0543467 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C2986665 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C2986665 (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 Malignant Neoplasms | 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 who have been disease-free for the last 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])
C0006826 (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 | Severe dyspnea requiring oxygen supplement
Item
patients with severe dyspnea at rest or requiring supplementary oxygen therapy
boolean
C0743330 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2080706 (UMLS CUI [2])
Comorbidity Serious Interferes with Therapeutic procedure | Lung disease Severe
Item
patients with other concurrent serious diseases that might 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])
C0087111 (UMLS CUI [1,4])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Heart Disease Excludes Trastuzumab | Medical condition Excludes Trastuzumab | Congestive heart failure | High risk Cardiac Arrhythmia Uncontrolled | Angina Pectoris Requiring Pharmaceutical Preparations | Valvular disease | Transmural infarct ECG | Poor hypertension control
Item
serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on ecg, poorly controlled hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0728747 (UMLS CUI [2,3])
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])
C0333561 (UMLS CUI [7,1])
C0013798 (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 Childbearing Potential | Contraceptive methods Unable | Contraceptive methods Unwilling
Item
women of childbearing potential and male patients with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods 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 enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate 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 Pharmaceutical Excipient | Hyaluronidase allergy | Hypersensitivity Adhesives | Severe allergy | Immunologic reaction Severe | Asthma Control Difficult
Item
known hypersensitivity to trastuzumab, murine proteins, to any excipients of herceptin including hyaluronidase, or the adhesive of the sc device, or a history of severe allergic or immunological reactions, e.g. 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])
C0020517 (UMLS CUI [5,1])
C0001516 (UMLS CUI [5,2])
C2945656 (UMLS CUI [6])
C0301873 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0004096 (UMLS CUI [8,1])
C0243148 (UMLS CUI [8,2])
C0332218 (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])
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