ID

16428

Description

A Study of Pertuzumab in Participants With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02491892

Lien

https://clinicaltrials.gov/show/NCT02491892

Mots-clés

Versions (2)
  1. 16/07/2016 16/07/2016 -
  2. 17/09/2021 17/09/2021 -
Téléchargé le

16 juillet 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02491892

Anglais

Eligibility Breast Cancer NCT02491892

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females at least 18 years of age
Description

Gender | Age

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically-confirmed metastatic breast cancer with low her2 expression and at least one measurable lesion according to response evaluation criteria in solid tumors (recist)
Description

Carcinoma breast stage IV | HER-2 protein overexpression low | Measurable lesion

Type de données

boolean

Alias
UMLS CUI [1]
C0278488
UMLS CUI [2,1]
C3888504
UMLS CUI [2,2]
C0205251
UMLS CUI [3]
C1513041
karnofsky performance status at least 80%
Description

Karnofsky Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0206065
disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
Description

Chemotherapy Quantity | Anthracycline Antibiotics | Disease Progression

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0003234
UMLS CUI [3]
C0242656
left ventricular ejection fraction (lvef) at least 50%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
adequate liver function
Description

Liver function

Type de données

boolean

Alias
UMLS CUI [1]
C0232741
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
Description

Malignant Neoplasm Manifestation of | Pleural effusion disorder | Ascites | Bone lesion

Type de données

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C1280464
UMLS CUI [2]
C0032227
UMLS CUI [3]
C0003962
UMLS CUI [4]
C0238792
pulmonary or central nervous system (cns) metastases
Description

Secondary malignant neoplasm of lung | CNS metastases

Type de données

boolean

Alias
UMLS CUI [1]
C0153676
UMLS CUI [2]
C0686377
chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of day 1
Description

Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy

Type de données

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0021083
UMLS CUI [4]
C0279025
previous treatment with any drug that targets the her2 receptor family
Description

Pharmaceutical Preparation Targeting erbB-2 Receptor

Type de données

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1521840
UMLS CUI [1,3]
C0069515
previous treatment with corticosteroids as cancer therapy
Description

cancer treatment | Adrenal Cortex Hormones

Type de données

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0001617
history of significant cardiac disease
Description

Heart Disease Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0750502
major surgery or trauma within 4 weeks of day 1
Description

major surgery | Major trauma

Type de données

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0332677
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT02491892

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
females at least 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Carcinoma breast stage IV | HER-2 protein overexpression low | Measurable lesion
Item
histologically-confirmed metastatic breast cancer with low her2 expression and at least one measurable lesion according to response evaluation criteria in solid tumors (recist)
boolean
C0278488 (UMLS CUI [1])
C3888504 (UMLS CUI [2,1])
C0205251 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3])
Karnofsky Performance Status
Item
karnofsky performance status at least 80%
boolean
C0206065 (UMLS CUI [1])
Chemotherapy Quantity | Anthracycline Antibiotics | Disease Progression
Item
disease progression on/after up to 2 different chemotherapy regimens, including an anthracycline-containing therapy
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0003234 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) at least 50%
boolean
C0428772 (UMLS CUI [1])
Liver function
Item
adequate liver function
boolean
C0232741 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Malignant Neoplasm Manifestation of | Pleural effusion disorder | Ascites | Bone lesion
Item
pleural effusions, ascites, or bone lesions as the only manifestation(s) of cancer
boolean
C0006826 (UMLS CUI [1,1])
C1280464 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C0238792 (UMLS CUI [4])
Secondary malignant neoplasm of lung | CNS metastases
Item
pulmonary or central nervous system (cns) metastases
boolean
C0153676 (UMLS CUI [1])
C0686377 (UMLS CUI [2])
Chemotherapy | Therapeutic radiology procedure | Immunotherapy | Hormone Therapy
Item
chemotherapy, radiotherapy, or immunotherapy within 4 weeks; or hormone therapy within 2 weeks of day 1
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
Pharmaceutical Preparation Targeting erbB-2 Receptor
Item
previous treatment with any drug that targets the her2 receptor family
boolean
C0013227 (UMLS CUI [1,1])
C1521840 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
cancer treatment | Adrenal Cortex Hormones
Item
previous treatment with corticosteroids as cancer therapy
boolean
C0920425 (UMLS CUI [1])
C0001617 (UMLS CUI [2])
Heart Disease Significant
Item
history of significant cardiac disease
boolean
C0018799 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
major surgery | Major trauma
Item
major surgery or trauma within 4 weeks of day 1
boolean
C0679637 (UMLS CUI [1])
C0332677 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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