ID

38003

Descrição

A Study of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01432886

Link

https://clinicaltrials.gov/show/NCT01432886

Palavras-chave

Versões (1)
  1. 07/09/2019 07/09/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

7 de setembro de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01432886

Inglês

Eligibility Breast Cancer NCT01432886

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically or cytologically confirmed with breast cancer
Descrição

Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678222
score 3+ by immunohistochemistry (ihc) or her2 positive by fluorescence in situ hybridization (fish) method
Descrição

Score Positive Immunohistochemistry | HER2 Positive FISH

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0449820
UMLS CUI [1,2]
C1514241
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C2348909
UMLS CUI [2,2]
C0162789
subjects who meet any of the following criteria:
Descrição

Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
Descrição

Disease recurrence During Adjuvant Chemotherapy | trastuzumab | taxane

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679254
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0085533
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0215136
evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
Descrição

Disease recurrence post Adjuvant Chemotherapy | trastuzumab | taxane

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0679254
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0085533
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0215136
experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer
Descrição

Prior Chemotherapy Advanced breast cancer | Prior Chemotherapy Breast cancer recurrent | trastuzumab | taxane

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C3495917
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0278493
UMLS CUI [3]
C0728747
UMLS CUI [4]
C0215136
adequate organ function
Descrição

Organ function

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0678852
eastern cooperative oncology group (ecog)-performance status (ps) is 0 or 1
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
subjects who have submitted written informed consent for study entry
Descrição

Informed Consent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
Descrição

Metastatic malignant neoplasm to brain Associated with Symptoms Clinical | Treatment required for Metastatic malignant neoplasm to brain

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205210
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C0220650
subjects with severe active infection requiring active treatment
Descrição

Treatment required for Infection Severe

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0332121
UMLS CUI [1,2]
C3714514
UMLS CUI [1,3]
C0205082
subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
Descrição

PLEURAL EFFUSION LARGE | Ascites | Pericardial effusion Requirement Drainage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0747637
UMLS CUI [2]
C0003962
UMLS CUI [3,1]
C0031039
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C0013103
hypersensitivity to trastuzumab, halicondrin b or halicondrin b chemical derivatives
Descrição

Hypersensitivity Trastuzumab | Hypersensitivity Halichondrin B | Hypersensitivity Halichondrin B Derivative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0120715
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0120715
UMLS CUI [3,3]
C1527240
known positive for human immunodeficiency virus (hiv) test or positive for hepatitis b surface (hbs antigen) or hepatitis c (hcv) by serum test.
Descrição

HIV Seropositivity | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C virus

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2,1]
C0242089
UMLS CUI [2,2]
C0019168
UMLS CUI [3,1]
C0242089
UMLS CUI [3,2]
C0220847
subjects who are pregnant (positive b-hcg test) or breastfeeding
Descrição

Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0430060
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C0006147
subjects judged to be ineligible for this study by the principal investigator or sub-investigator.
Descrição

Study Subject Participation Status Ineligible

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
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Similar models

Eligibility Breast Cancer NCT01432886

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
females aged greater than or equal to 20 years and less than 75 years at the time of informed consent.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
histologically or cytologically confirmed with breast cancer
boolean
C0678222 (UMLS CUI [1])
Score Positive Immunohistochemistry | HER2 Positive FISH
Item
score 3+ by immunohistochemistry (ihc) or her2 positive by fluorescence in situ hybridization (fish) method
boolean
C0449820 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C2348909 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Criteria Fulfill
Item
subjects who meet any of the following criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Disease recurrence During Adjuvant Chemotherapy | trastuzumab | taxane
Item
evidence of recurrence during adjuvant chemotherapy with trastuzumab and taxane
boolean
C0679254 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
Disease recurrence post Adjuvant Chemotherapy | trastuzumab | taxane
Item
evidence of recurrence within 6 months after adjuvant chemotherapy with trastuzumab and taxane
boolean
C0679254 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0085533 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
Prior Chemotherapy Advanced breast cancer | Prior Chemotherapy Breast cancer recurrent | trastuzumab | taxane
Item
experienced prior chemotherapy including trastuzumab and taxane for advanced or recurrent breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C3495917 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0278493 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3])
C0215136 (UMLS CUI [4])
Organ function
Item
adequate organ function
boolean
C0678852 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog)-performance status (ps) is 0 or 1
boolean
C1520224 (UMLS CUI [1])
Informed Consent
Item
subjects who have submitted written informed consent for study entry
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Associated with Symptoms Clinical | Treatment required for Metastatic malignant neoplasm to brain
Item
subjects with known brain metastasis accompanied by clinical symptoms or requiring active treatment
boolean
C0220650 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
C0332121 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
Treatment required for Infection Severe
Item
subjects with severe active infection requiring active treatment
boolean
C0332121 (UMLS CUI [1,1])
C3714514 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
PLEURAL EFFUSION LARGE | Ascites | Pericardial effusion Requirement Drainage
Item
subjects with large pleural effusions, ascites, or pericardial effusions requiring drainage.
boolean
C0747637 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0031039 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0013103 (UMLS CUI [3,3])
Hypersensitivity Trastuzumab | Hypersensitivity Halichondrin B | Hypersensitivity Halichondrin B Derivative
Item
hypersensitivity to trastuzumab, halicondrin b or halicondrin b chemical derivatives
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0120715 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0120715 (UMLS CUI [3,2])
C1527240 (UMLS CUI [3,3])
HIV Seropositivity | Serology positive Hepatitis B Surface Antigens | Serology positive Hepatitis C virus
Item
known positive for human immunodeficiency virus (hiv) test or positive for hepatitis b surface (hbs antigen) or hepatitis c (hcv) by serum test.
boolean
C0019699 (UMLS CUI [1])
C0242089 (UMLS CUI [2,1])
C0019168 (UMLS CUI [2,2])
C0242089 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
Pregnancy | Serum pregnancy test (B-HCG) Positive | Breast Feeding
Item
subjects who are pregnant (positive b-hcg test) or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0430060 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
Study Subject Participation Status Ineligible
Item
subjects judged to be ineligible for this study by the principal investigator or sub-investigator.
boolean
C2348568 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
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