ID

33349

Beschrijving

Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00788333

Link

https://clinicaltrials.gov/show/NCT00788333

Trefwoorden

  1. 06-12-18 06-12-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

6 december 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT00788333

Eligibility Breast Cancer NCT00788333

Criteria
Beschrijving

Criteria

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects with locally advanced or metastatic her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. prior treatment with other her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab dm-1 etc.) is allowed
Beschrijving

HER2-positive carcinoma of breast Advanced Locally | HER2-positive carcinoma of breast metastatic | Tuzumab Regimen Quantity failed | Pharmaceutical Preparations HER2 Targeted | lapatinib | pertuzumab | Trastuzumab-DM1

Datatype

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0205179
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1960398
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C0040808
UMLS CUI [3,3]
C1265611
UMLS CUI [3,4]
C0231175
UMLS CUI [4,1]
C0013227
UMLS CUI [4,2]
C0069515
UMLS CUI [4,3]
C1521840
UMLS CUI [5]
C1506770
UMLS CUI [6]
C1328025
UMLS CUI [7]
C2935436
histologic or cytologic diagnosis of her-2-positive breast cancer
Beschrijving

HER2-positive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C1960398
ecog status 0 - 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
symptomatic brain metastasis
Beschrijving

Metastatic malignant neoplasm to brain Symptomatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
any condition requiring chronic use of steroids
Beschrijving

Condition Requirement Steroids chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0038317
UMLS CUI [1,4]
C0205191
any disorder with dysregulation of glucose homeostasis (history of type 1 or 2 diabetes mellitus or prediabetic symptoms
Beschrijving

Abnormal glucose homeostasis | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Symptoms Prediabetic

Datatype

boolean

Alias
UMLS CUI [1]
C4023598
UMLS CUI [2]
C0011854
UMLS CUI [3]
C0011860
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0362046
history of glucose intolerance
Beschrijving

Glucose intolerance

Datatype

boolean

Alias
UMLS CUI [1]
C0271650
women of child-bearing potential unwilling or unable to use acceptable contraception methods
Beschrijving

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582

Similar models

Eligibility Breast Cancer NCT00788333

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Item Group
C1512693 (UMLS CUI)
HER2-positive carcinoma of breast Advanced Locally | HER2-positive carcinoma of breast metastatic | Tuzumab Regimen Quantity failed | Pharmaceutical Preparations HER2 Targeted | lapatinib | pertuzumab | Trastuzumab-DM1
Item
subjects with locally advanced or metastatic her-2-positive breast cancer who have failed at least one trastuzumab containing regimen. prior treatment with other her-2-targeted agents (e.g. lapatinib, pertuzumab, trastuzumab dm-1 etc.) is allowed
boolean
C1960398 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1960398 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0040808 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0231175 (UMLS CUI [3,4])
C0013227 (UMLS CUI [4,1])
C0069515 (UMLS CUI [4,2])
C1521840 (UMLS CUI [4,3])
C1506770 (UMLS CUI [5])
C1328025 (UMLS CUI [6])
C2935436 (UMLS CUI [7])
HER2-positive carcinoma of breast
Item
histologic or cytologic diagnosis of her-2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
ECOG performance status
Item
ecog status 0 - 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Condition Requirement Steroids chronic
Item
any condition requiring chronic use of steroids
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0038317 (UMLS CUI [1,3])
C0205191 (UMLS CUI [1,4])
Abnormal glucose homeostasis | Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Symptoms Prediabetic
Item
any disorder with dysregulation of glucose homeostasis (history of type 1 or 2 diabetes mellitus or prediabetic symptoms
boolean
C4023598 (UMLS CUI [1])
C0011854 (UMLS CUI [2])
C0011860 (UMLS CUI [3])
C1457887 (UMLS CUI [4,1])
C0362046 (UMLS CUI [4,2])
Glucose intolerance
Item
history of glucose intolerance
boolean
C0271650 (UMLS CUI [1])
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable
Item
women of child-bearing potential unwilling or unable to use acceptable contraception methods
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial