ID

38003

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.09.19 07.09.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. September 2019

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01432886

Englisch

Eligibility Breast Cancer NCT01432886

1 Formulare  
Inclusion Criteria
Beschreibung

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.
Beschreibung

Gender | Age

Datentyp

boolean

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

Breast Carcinoma

Datentyp

boolean

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

Score Positive Immunohistochemistry | HER2 Positive FISH

Datentyp

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:
Beschreibung

Criteria Fulfill

Datentyp

boolean

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

Disease recurrence During Adjuvant Chemotherapy | trastuzumab | taxane

Datentyp

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
Beschreibung

Disease recurrence post Adjuvant Chemotherapy | trastuzumab | taxane

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Organ function

Datentyp

boolean

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

ECOG performance status

Datentyp

boolean

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

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

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

Datentyp

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
Beschreibung

Treatment required for Infection Severe

Datentyp

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.
Beschreibung

PLEURAL EFFUSION LARGE | Ascites | Pericardial effusion Requirement Drainage

Datentyp

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
Beschreibung

Hypersensitivity Trastuzumab | Hypersensitivity Halichondrin B | Hypersensitivity Halichondrin B Derivative

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Study Subject Participation Status Ineligible

Datentyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1512714
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Ähnliche Modelle

Eligibility Breast Cancer NCT01432886

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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