ID

27182

Beschrijving

A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01038804

Link

https://clinicaltrials.gov/show/NCT01038804

Trefwoorden

Versies (1)
  1. 02-11-17 02-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

2 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01038804

Engels

Eligibility Breast Cancer NCT01038804

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically- or cytologically-proven adenocarcinoma of the breast that is her2 negative. subjects with hormone receptor positive or negative status are eligible. additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and her2 negative) are eligible
Beschrijving

Breast adenocarcinoma HER2 negative | Hormone Receptor Status Positive | Hormone Receptor Status Negative | Triple-Negative Breast Cancer

Datatype

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C4087376
UMLS CUI [2,1]
C0019929
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C1514241
UMLS CUI [3,1]
C0019929
UMLS CUI [3,2]
C0449438
UMLS CUI [3,3]
C1513916
UMLS CUI [4]
C2348819
no prior chemotherapy regimen for metastatic breast cancer
Beschrijving

Prior Chemotherapy Absent Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0346993
eastern cooperative oncology group (ecog) performance status ≤ 1 at the baseline visit
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
the subject's life expectancy is estimated to be > 12 weeks at the baseline visit
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
the subject must be non-pregnant and non-lactating. all sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period
Beschrijving

Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Sexually active Contraceptive methods

Datatype

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0006147
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0241028
UMLS CUI [3,3]
C0700589
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
hypersensitivity to docetaxel or polysorbate 80
Beschrijving

Hypersensitivity docetaxel | Hypersensitivity Polysorbate 80

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0246415
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0032601
neuropathy ≥ grade 2 at the baseline visit
Beschrijving

Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
Beschrijving

Metastatic malignant neoplasm to brain Medical History | Metastatic Malignant Neoplasm to the Leptomeninges Medical History | Metastatic malignant neoplasm to brain Physical Examination | Metastatic Malignant Neoplasm to the Leptomeninges Physical Examination

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0262926
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0262926
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0031809
UMLS CUI [4,1]
C1704231
UMLS CUI [4,2]
C0031809
the subject has known human immunodeficiency virus (hiv), hepatitis b surface antigen or hepatitis c antibody
Beschrijving

HIV Antibodies | Hepatitis B Virus Surface Antibody | Hepatitis C Antibodies

Datatype

boolean

Alias
UMLS CUI [1]
C0019683
UMLS CUI [2]
C0369334
UMLS CUI [3]
C0166049
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Similar models

Eligibility Breast Cancer NCT01038804

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma HER2 negative | Hormone Receptor Status Positive | Hormone Receptor Status Negative | Triple-Negative Breast Cancer
Item
histologically- or cytologically-proven adenocarcinoma of the breast that is her2 negative. subjects with hormone receptor positive or negative status are eligible. additionally, subjects with triple negative status (meaning estrogen receptor negative, progesterone receptor negative and her2 negative) are eligible
boolean
C0858252 (UMLS CUI [1,1])
C4087376 (UMLS CUI [1,2])
C0019929 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0019929 (UMLS CUI [3,1])
C0449438 (UMLS CUI [3,2])
C1513916 (UMLS CUI [3,3])
C2348819 (UMLS CUI [4])
Prior Chemotherapy Absent Secondary malignant neoplasm of female breast
Item
no prior chemotherapy regimen for metastatic breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 1 at the baseline visit
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
the subject's life expectancy is estimated to be > 12 weeks at the baseline visit
boolean
C0023671 (UMLS CUI [1])
Pregnancy Absent | Breast Feeding Absent | Childbearing Potential Sexually active Contraceptive methods
Item
the subject must be non-pregnant and non-lactating. all sexually active subjects of childbearing potential must agree to use an adequate method of contraception throughout the study period
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006147 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0241028 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity docetaxel | Hypersensitivity Polysorbate 80
Item
hypersensitivity to docetaxel or polysorbate 80
boolean
C0020517 (UMLS CUI [1,1])
C0246415 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
Neuropathy CTCAE Grades
Item
neuropathy ≥ grade 2 at the baseline visit
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Medical History | Metastatic Malignant Neoplasm to the Leptomeninges Medical History | Metastatic malignant neoplasm to brain Physical Examination | Metastatic Malignant Neoplasm to the Leptomeninges Physical Examination
Item
known brain or leptomeningeal metastasis as assessed through medical history review and physical examination
boolean
C0220650 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1704231 (UMLS CUI [2,1])
C0262926 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0031809 (UMLS CUI [3,2])
C1704231 (UMLS CUI [4,1])
C0031809 (UMLS CUI [4,2])
HIV Antibodies | Hepatitis B Virus Surface Antibody | Hepatitis C Antibodies
Item
the subject has known human immunodeficiency virus (hiv), hepatitis b surface antigen or hepatitis c antibody
boolean
C0019683 (UMLS CUI [1])
C0369334 (UMLS CUI [2])
C0166049 (UMLS CUI [3])
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