ID

30798

Beskrivning

Trastuzumab Optimization Trial in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00637325

Länk

https://clinicaltrials.gov/show/NCT00637325

Nyckelord

Versioner (1)
  1. 2018-06-20 2018-06-20 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

20 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic or Locally Advanced Breast Cancer NCT00637325

Engelsk

Eligibility Metastatic or Locally Advanced Breast Cancer NCT00637325

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
>18 years of age. patients older of 70 years of age are eligible on the basis of an individual risk-benefit assessment by the investigator
Beskrivning

Age | Risk benefit ratio assessment

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C1827488
histologically confirmed breast cancer with locally advanced and/or metastatic disease
Beskrivning

Breast Carcinoma | Advanced disease Local | Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
UMLS CUI [2,1]
C0679246
UMLS CUI [2,2]
C0205276
UMLS CUI [3]
C0027627
over expression of her2 (3+) as determined by ihc or amplification of her2/c-erbb2 by fish/cish of the primary tumour or of a metastasis
Beskrivning

HER2 Overexpression Immunohistochemistry | HER2 gene amplification Primary tumor FISH | HER2 gene amplification Primary tumor CISH | HER2 gene amplification Neoplasm Metastasis FISH | HER2 gene amplification Neoplasm Metastasis CISH

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0677930
UMLS CUI [2,3]
C0162789
UMLS CUI [3,1]
C1512127
UMLS CUI [3,2]
C0677930
UMLS CUI [3,3]
C1516514
UMLS CUI [4,1]
C1512127
UMLS CUI [4,2]
C0027627
UMLS CUI [4,3]
C0162789
UMLS CUI [5,1]
C1512127
UMLS CUI [5,2]
C0027627
UMLS CUI [5,3]
C1516514
assessable disease. the presence of measurable disease is not needed for enrolment. patients with bone lesions, ascites and pleural effusion as only sites of disease are considered eligible
Beskrivning

Evaluable Disease | Bone lesion Site Solitary | Ascites Site Solitary | Pleural effusion Site Solitary

Datatyp

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2,1]
C0238792
UMLS CUI [2,2]
C1515974
UMLS CUI [2,3]
C0205171
UMLS CUI [3,1]
C0003962
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C0205171
UMLS CUI [4,1]
C0032227
UMLS CUI [4,2]
C1515974
UMLS CUI [4,3]
C0205171
completion of a first line chemotherapy in association with trastuzumab given for at least 6 months for advanced disease. the last dose of trastuzumab should have to be given within 6 weeks prior to randomisation for treatments given with a 3 weekly schedule or within 3 weeks if a weekly schedule was used (only for maintenance study)
Beskrivning

Chemotherapy First line Advanced disease | Trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1708063
UMLS CUI [1,3]
C0679246
UMLS CUI [2]
C0728747
progressive disease during or within 6 months from the completion of a first line chemotherapy plus trastuzumab for advanced disease or within 6 months from the completion of an adjuvant treatment for early disease (only for 2nd line study). patients progressing more than 6 months after the completion of a first line trastuzumab-containing regimen should be re-treated with the previous regimen and included in 2nd line study after evidence of progression.
Beskrivning

Progressive Disease | Chemotherapy First line Advanced disease | Trastuzumab | Adjuvant therapy Early disease | Retreatment Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C1335499
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1708063
UMLS CUI [2,3]
C0679246
UMLS CUI [3]
C0728747
UMLS CUI [4,1]
C0677850
UMLS CUI [4,2]
C0679245
UMLS CUI [5,1]
C0376495
UMLS CUI [5,2]
C0242656
signed written informed consent obtained prior to any study specific study procedures
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
ecog-ps >2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
pregnant or lactating women. women of childbearing potential must implement adequate contraceptive measures
Beskrivning

Pregnancy | Lactation | Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative Surgery Cancer Other | Exception Disease Free of

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1511562
UMLS CUI [5,3]
C1707251
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
baseline lvef <50% (measured by echocardiography or muga) performed within 4 weeks prior to randomisation. history of documented congestive heart failure, angina pectoris requiring antianginal medication, evidence of transmural infarction ecg, poorly controlled hypertension (systolic > 180 mmhg or diastolic > 100 mmhg); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
Beskrivning

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA | Congestive heart failure | Angina Pectoris Requirement Antianginals | Transmural myocardial infarction Electrocardiography | Poor hypertension control | Systolic Pressure | Diastolic blood pressure | Heart valve disease | High risk of Cardiac Arrhythmia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C3537168
UMLS CUI [5,1]
C1400513
UMLS CUI [5,2]
C1623258
UMLS CUI [6]
C0421190
UMLS CUI [7]
C0871470
UMLS CUI [8]
C0428883
UMLS CUI [9]
C0018824
UMLS CUI [10,1]
C0332167
UMLS CUI [10,2]
C0003811
UMLS CUI [10,3]
C0205318
presence of cns metastases, not amenable to curative therapy. patients with previously treated cns metastases must be asymptomatic and stable at radiological imaging from at least 3 months
Beskrivning

CNS metastases Inappropriate Curative treatment | Prior Therapy CNS metastases | CNS metastases Asymptomatic Stable Radiographic imaging procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C1273390
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0686377
UMLS CUI [3,1]
C0686377
UMLS CUI [3,2]
C0231221
UMLS CUI [3,3]
C0205360
UMLS CUI [3,4]
C1962945
patients with dyspnoea at rest due to malignant or other disease, or who require supportive oxygen therapy. patients with pre-existing lung disease or advanced pulmonary involvement may be at increased risk of serious toxicities with trastuzumab and should be evaluated carefully before entry into the study
Beskrivning

Resting Dyspnea Due to Malignant Neoplasms | Resting Dyspnea Due to Disease | Resting Dyspnea Requirement Oxygen therapy support | Lung diseases Pre-existing At risk Toxicity effect | Pulmonary involvement Advanced At risk Toxicity | Relationship Trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0743330
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0006826
UMLS CUI [2,1]
C0743330
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0012634
UMLS CUI [3,1]
C0743330
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C3872899
UMLS CUI [4,1]
C0024115
UMLS CUI [4,2]
C2347662
UMLS CUI [4,3]
C1444641
UMLS CUI [4,4]
C0600688
UMLS CUI [5,1]
C0748159
UMLS CUI [5,2]
C0205179
UMLS CUI [5,3]
C1444641
UMLS CUI [5,4]
C0600688
UMLS CUI [6,1]
C0439849
UMLS CUI [6,2]
C0728747
concomitant chemotherapy with anthracyclines, including liposomal drugs (only for 2nd line study)
Beskrivning

Chemotherapy | Anthracyclines | Pharmaceutical Preparations Liposomal

Datatyp

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0282564
UMLS CUI [3,1]
C0013227
UMLS CUI [3,2]
C0023828
treatment with any investigational drug within 30 days before beginning of enrolment in the trial
Beskrivning

Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0013230
history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of trastuzumab
Beskrivning

Medical contraindication Trastuzumab | Other medical condition | Dysfunction Metabolic | Physical Examination Finding | Laboratory test finding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0728747
UMLS CUI [2]
C3843040
UMLS CUI [3,1]
C3887504
UMLS CUI [3,2]
C0311400
UMLS CUI [4,1]
C0031809
UMLS CUI [4,2]
C0243095
UMLS CUI [5]
C0587081
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Similar models

Eligibility Metastatic or Locally Advanced Breast Cancer NCT00637325

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Risk benefit ratio assessment
Item
>18 years of age. patients older of 70 years of age are eligible on the basis of an individual risk-benefit assessment by the investigator
boolean
C0001779 (UMLS CUI [1])
C1827488 (UMLS CUI [2])
Breast Carcinoma | Advanced disease Local | Neoplasm Metastasis
Item
histologically confirmed breast cancer with locally advanced and/or metastatic disease
boolean
C0678222 (UMLS CUI [1])
C0679246 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
HER2 Overexpression Immunohistochemistry | HER2 gene amplification Primary tumor FISH | HER2 gene amplification Primary tumor CISH | HER2 gene amplification Neoplasm Metastasis FISH | HER2 gene amplification Neoplasm Metastasis CISH
Item
over expression of her2 (3+) as determined by ihc or amplification of her2/c-erbb2 by fish/cish of the primary tumour or of a metastasis
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C1512127 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C1512127 (UMLS CUI [3,1])
C0677930 (UMLS CUI [3,2])
C1516514 (UMLS CUI [3,3])
C1512127 (UMLS CUI [4,1])
C0027627 (UMLS CUI [4,2])
C0162789 (UMLS CUI [4,3])
C1512127 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
C1516514 (UMLS CUI [5,3])
Evaluable Disease | Bone lesion Site Solitary | Ascites Site Solitary | Pleural effusion Site Solitary
Item
assessable disease. the presence of measurable disease is not needed for enrolment. patients with bone lesions, ascites and pleural effusion as only sites of disease are considered eligible
boolean
C1516986 (UMLS CUI [1])
C0238792 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C0003962 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
C0032227 (UMLS CUI [4,1])
C1515974 (UMLS CUI [4,2])
C0205171 (UMLS CUI [4,3])
Chemotherapy First line Advanced disease | Trastuzumab
Item
completion of a first line chemotherapy in association with trastuzumab given for at least 6 months for advanced disease. the last dose of trastuzumab should have to be given within 6 weeks prior to randomisation for treatments given with a 3 weekly schedule or within 3 weeks if a weekly schedule was used (only for maintenance study)
boolean
C0392920 (UMLS CUI [1,1])
C1708063 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
Progressive Disease | Chemotherapy First line Advanced disease | Trastuzumab | Adjuvant therapy Early disease | Retreatment Disease Progression
Item
progressive disease during or within 6 months from the completion of a first line chemotherapy plus trastuzumab for advanced disease or within 6 months from the completion of an adjuvant treatment for early disease (only for 2nd line study). patients progressing more than 6 months after the completion of a first line trastuzumab-containing regimen should be re-treated with the previous regimen and included in 2nd line study after evidence of progression.
boolean
C1335499 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3])
C0677850 (UMLS CUI [4,1])
C0679245 (UMLS CUI [4,2])
C0376495 (UMLS CUI [5,1])
C0242656 (UMLS CUI [5,2])
Informed Consent
Item
signed written informed consent obtained prior to any study specific study procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ECOG performance status
Item
ecog-ps >2
boolean
C1520224 (UMLS CUI [1])
Pregnancy | Lactation | Childbearing Potential Contraceptive methods
Item
pregnant or lactating women. women of childbearing potential must implement adequate contraceptive measures
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Curative Surgery Cancer Other | Exception Disease Free of
Item
previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1511562 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA | Congestive heart failure | Angina Pectoris Requirement Antianginals | Transmural myocardial infarction Electrocardiography | Poor hypertension control | Systolic Pressure | Diastolic blood pressure | Heart valve disease | High risk of Cardiac Arrhythmia Uncontrolled
Item
baseline lvef <50% (measured by echocardiography or muga) performed within 4 weeks prior to randomisation. history of documented congestive heart failure, angina pectoris requiring antianginal medication, evidence of transmural infarction ecg, poorly controlled hypertension (systolic > 180 mmhg or diastolic > 100 mmhg); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0002962 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C3537168 (UMLS CUI [4,3])
C1400513 (UMLS CUI [5,1])
C1623258 (UMLS CUI [5,2])
C0421190 (UMLS CUI [6])
C0871470 (UMLS CUI [7])
C0428883 (UMLS CUI [8])
C0018824 (UMLS CUI [9])
C0332167 (UMLS CUI [10,1])
C0003811 (UMLS CUI [10,2])
C0205318 (UMLS CUI [10,3])
CNS metastases Inappropriate Curative treatment | Prior Therapy CNS metastases | CNS metastases Asymptomatic Stable Radiographic imaging procedure
Item
presence of cns metastases, not amenable to curative therapy. patients with previously treated cns metastases must be asymptomatic and stable at radiological imaging from at least 3 months
boolean
C0686377 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C1273390 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0686377 (UMLS CUI [3,1])
C0231221 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1962945 (UMLS CUI [3,4])
Resting Dyspnea Due to Malignant Neoplasms | Resting Dyspnea Due to Disease | Resting Dyspnea Requirement Oxygen therapy support | Lung diseases Pre-existing At risk Toxicity effect | Pulmonary involvement Advanced At risk Toxicity | Relationship Trastuzumab
Item
patients with dyspnoea at rest due to malignant or other disease, or who require supportive oxygen therapy. patients with pre-existing lung disease or advanced pulmonary involvement may be at increased risk of serious toxicities with trastuzumab and should be evaluated carefully before entry into the study
boolean
C0743330 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C0743330 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0743330 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3872899 (UMLS CUI [3,3])
C0024115 (UMLS CUI [4,1])
C2347662 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0600688 (UMLS CUI [4,4])
C0748159 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C1444641 (UMLS CUI [5,3])
C0600688 (UMLS CUI [5,4])
C0439849 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
Chemotherapy | Anthracyclines | Pharmaceutical Preparations Liposomal
Item
concomitant chemotherapy with anthracyclines, including liposomal drugs (only for 2nd line study)
boolean
C0392920 (UMLS CUI [1])
C0282564 (UMLS CUI [2])
C0013227 (UMLS CUI [3,1])
C0023828 (UMLS CUI [3,2])
Investigational New Drugs
Item
treatment with any investigational drug within 30 days before beginning of enrolment in the trial
boolean
C0013230 (UMLS CUI [1])
Medical contraindication Trastuzumab | Other medical condition | Dysfunction Metabolic | Physical Examination Finding | Laboratory test finding
Item
history or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of trastuzumab
boolean
C1301624 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2])
C3887504 (UMLS CUI [3,1])
C0311400 (UMLS CUI [3,2])
C0031809 (UMLS CUI [4,1])
C0243095 (UMLS CUI [4,2])
C0587081 (UMLS CUI [5])
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