ID

26212

Description

Studying the Benefits of Adjuvant Sequential vs. Combined Taxane Based Chemotherapy, Followed by Different Biological Treatment Strategies in Early, HER2-positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00670878

Link

https://clinicaltrials.gov/show/NCT00670878

Keywords

Versions (1)
  1. 10/11/17 10/11/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00670878

English

Eligibility Breast Cancer NCT00670878

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
primary epithelial invasive carcinoma of the breast pt1-4, pn0-3, m0
Description

Invasive carcinoma of breast epithelial primary TNM Breast tumor staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0221908
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C0474926
evidence of her2-neu overexpressing (ihc +++) or amplifying (fish +) tumor
Description

Neoplasm HER2 Protein Overexpression Immunohistochemistry Positive | Neoplasm HER2 gene amplification FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C0069515
UMLS CUI [1,3]
C1514559
UMLS CUI [1,4]
C0021044
UMLS CUI [1,5]
C1514241
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1512127
UMLS CUI [2,3]
C0162789
UMLS CUI [2,4]
C1514241
histopathological proof of axillary lymph node metastases (pn1-3) or high risk node negative, defined as at least two criteria of the following: 'pt³2, histopathological grade 3, age £ 35, negative hormone receptor'
Description

AXILLARY LYMPH NODE METASTASIS TNM clinical staging | Negative Axillary Lymph Node High risk | TNM clinical staging | Histopathologic Grade | Age | Hormone Receptor Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0741344
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0279781
UMLS CUI [2,2]
C0332167
UMLS CUI [3]
C3258246
UMLS CUI [4]
C0919553
UMLS CUI [5]
C0001779
UMLS CUI [6,1]
C0019929
UMLS CUI [6,2]
C1513916
complete resection of the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
Description

Complete excision Primary tumor | Surgical margins Free of Invasive Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0015250
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0229985
UMLS CUI [2,2]
C0332296
UMLS CUI [2,3]
C1334274
females >= 18 years of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
performance status <2 on ecog-scale
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow reserve: leucocytes ³ 3.0 x 109/l and platelets ³ 100 x 109/l
Description

Mature Neutrophils Present Bone Marrow Complete | White Blood Cell Count procedure | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1708947
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0205197
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0032181
bilirubin within one fold of the reference laboratory's normal range, asat (sgot), alat (sgpt) and ap within 1,5 fold of the reference laboratory's normal range for patients
Description

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
intention of regular follow up visits for the duration of the study
Description

Intention Follow-up visits Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C1283828
UMLS CUI [1,2]
C0589121
UMLS CUI [1,3]
C0205272
ability to understand the nature of the study and to give written informed consent
Description

Comprehension Study Protocol | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [2]
C0021430
women of childbearing potential must agree to use an effective method of contraception (pearl-index < 1, e.g. , intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
Description

Childbearing Potential Contraceptive methods | Intrauterine Devices | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0021900
UMLS CUI [3]
C0015787
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
inflammatory breast cancer
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study
Description

Cytotoxic therapy | Antineoplastic Therapy Systemic

Data type

boolean

Alias
UMLS CUI [1]
C0677881
UMLS CUI [2,1]
C2346834
UMLS CUI [2,2]
C0205373
a second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
Description

Second Primary Cancers | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated

Data type

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
cardiomyopathy with impaired ventricular function (nyha > ii), cardiac arrhythmias influencing lvef and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
Description

Cardiomyopathy | Ventricular Function Impaired New York Heart Association Classification | Cardiac Arrhythmia Affecting Left ventricular ejection fraction | Cardiac Arrhythmia Requirement Pharmaceutical Preparations | Myocardial Infarction | Angina Pectoris | Uncontrolled hypertension

Data type

boolean

Alias
UMLS CUI [1]
C0878544
UMLS CUI [2,1]
C0080309
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C1275491
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0428772
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0013227
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0002962
UMLS CUI [7]
C1868885
any known hypersensitivity reaction against docetaxel, epirubicin, cyclophosphamide, gemcitabine or any other medication included in the study protocol. the contraindication, warning notices and measures of precaution of the products, as notified in the product information, have to be respected
Description

Hypersensitivity docetaxel | Epirubicin allergy | Cyclophosphamide allergy | Hypersensitivity gemcitabine | Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246415
UMLS CUI [2]
C0570689
UMLS CUI [3]
C0570670
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0045093
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013230
instable diabetes mellitus, out of sufficient medical control
Description

Brittle diabetes | Diabetes mellitus poor control

Data type

boolean

Alias
UMLS CUI [1]
C0342302
UMLS CUI [2]
C0860161
use of any investigational agent within 3 weeks prior to inclusion
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients in pregnancy or breast feeding (in premenopausal women contraception has to be assured)
Description

Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0232969
UMLS CUI [3,2]
C0700589
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Similar models

Eligibility Breast Cancer NCT00670878

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast epithelial primary TNM Breast tumor staging
Item
primary epithelial invasive carcinoma of the breast pt1-4, pn0-3, m0
boolean
C0853879 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
Neoplasm HER2 Protein Overexpression Immunohistochemistry Positive | Neoplasm HER2 gene amplification FISH Positive
Item
evidence of her2-neu overexpressing (ihc +++) or amplifying (fish +) tumor
boolean
C0027651 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1514559 (UMLS CUI [1,3])
C0021044 (UMLS CUI [1,4])
C1514241 (UMLS CUI [1,5])
C0027651 (UMLS CUI [2,1])
C1512127 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C1514241 (UMLS CUI [2,4])
AXILLARY LYMPH NODE METASTASIS TNM clinical staging | Negative Axillary Lymph Node High risk | TNM clinical staging | Histopathologic Grade | Age | Hormone Receptor Negative
Item
histopathological proof of axillary lymph node metastases (pn1-3) or high risk node negative, defined as at least two criteria of the following: 'pt³2, histopathological grade 3, age £ 35, negative hormone receptor'
boolean
C0741344 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0279781 (UMLS CUI [2,1])
C0332167 (UMLS CUI [2,2])
C3258246 (UMLS CUI [3])
C0919553 (UMLS CUI [4])
C0001779 (UMLS CUI [5])
C0019929 (UMLS CUI [6,1])
C1513916 (UMLS CUI [6,2])
Complete excision Primary tumor | Surgical margins Free of Invasive Carcinoma
Item
complete resection of the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
boolean
C0015250 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0229985 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C1334274 (UMLS CUI [2,3])
Gender | Age
Item
females >= 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
ECOG performance status
Item
performance status <2 on ecog-scale
boolean
C1520224 (UMLS CUI [1])
Mature Neutrophils Present Bone Marrow Complete | White Blood Cell Count procedure | Platelet Count measurement
Item
adequate bone marrow reserve: leucocytes ³ 3.0 x 109/l and platelets ³ 100 x 109/l
boolean
C1708947 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0023508 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
bilirubin within one fold of the reference laboratory's normal range, asat (sgot), alat (sgpt) and ap within 1,5 fold of the reference laboratory's normal range for patients
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Intention Follow-up visits Regular
Item
intention of regular follow up visits for the duration of the study
boolean
C1283828 (UMLS CUI [1,1])
C0589121 (UMLS CUI [1,2])
C0205272 (UMLS CUI [1,3])
Comprehension Study Protocol | Informed Consent
Item
ability to understand the nature of the study and to give written informed consent
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Intrauterine Devices | Female Sterilization
Item
women of childbearing potential must agree to use an effective method of contraception (pearl-index < 1, e.g. , intrauterine devices or sterilization) during treatment and for at least 6 months thereafter.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0021900 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Inflammatory Breast Carcinoma
Item
inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Cytotoxic therapy | Antineoplastic Therapy Systemic
Item
previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study
boolean
C0677881 (UMLS CUI [1])
C2346834 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
Second Primary Cancers | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma Treated
Item
a second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
Cardiomyopathy | Ventricular Function Impaired New York Heart Association Classification | Cardiac Arrhythmia Affecting Left ventricular ejection fraction | Cardiac Arrhythmia Requirement Pharmaceutical Preparations | Myocardial Infarction | Angina Pectoris | Uncontrolled hypertension
Item
cardiomyopathy with impaired ventricular function (nyha > ii), cardiac arrhythmias influencing lvef and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
boolean
C0878544 (UMLS CUI [1])
C0080309 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0003811 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0428772 (UMLS CUI [3,3])
C0003811 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0013227 (UMLS CUI [4,3])
C0027051 (UMLS CUI [5])
C0002962 (UMLS CUI [6])
C1868885 (UMLS CUI [7])
Hypersensitivity docetaxel | Epirubicin allergy | Cyclophosphamide allergy | Hypersensitivity gemcitabine | Hypersensitivity Investigational New Drugs
Item
any known hypersensitivity reaction against docetaxel, epirubicin, cyclophosphamide, gemcitabine or any other medication included in the study protocol. the contraindication, warning notices and measures of precaution of the products, as notified in the product information, have to be respected
boolean
C0020517 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C0570689 (UMLS CUI [2])
C0570670 (UMLS CUI [3])
C0020517 (UMLS CUI [4,1])
C0045093 (UMLS CUI [4,2])
C0020517 (UMLS CUI [5,1])
C0013230 (UMLS CUI [5,2])
Brittle diabetes | Diabetes mellitus poor control
Item
instable diabetes mellitus, out of sufficient medical control
boolean
C0342302 (UMLS CUI [1])
C0860161 (UMLS CUI [2])
Investigational New Drugs
Item
use of any investigational agent within 3 weeks prior to inclusion
boolean
C0013230 (UMLS CUI [1])
Pregnancy | Breast Feeding | Premenopausal state Contraceptive methods
Item
patients in pregnancy or breast feeding (in premenopausal women contraception has to be assured)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0232969 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
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