ID

37767

Beschrijving

A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00964704

Link

https://clinicaltrials.gov/show/NCT00964704

Trefwoorden

Versies (1)
  1. 22-08-19 22-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

22 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00964704

Engels

Eligibility Breast Cancer NCT00964704

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients, age >/=18 years
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
locally recurrent or metastatic her2-positive breast cancer
Beschrijving

HER2-positive carcinoma of breast Recurrent Locally | HER2-positive carcinoma of breast metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C2945760
UMLS CUI [1,3]
C1517927
UMLS CUI [2,1]
C1960398
UMLS CUI [2,2]
C1522484
disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
Beschrijving

Disease Progression During Adjuvant therapy | Disease Progression Post Adjuvant therapy | trastuzumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242656
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C0677850
UMLS CUI [2,1]
C0242656
UMLS CUI [2,2]
C0687676
UMLS CUI [2,3]
C0677850
UMLS CUI [3]
C0728747
lvef >/=55% at baseline
Beschrijving

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with bevacizumab or capecitabine
Beschrijving

bevacizumab | capecitabine

Datatype

boolean

Alias
UMLS CUI [1]
C0796392
UMLS CUI [2]
C0671970
anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
Beschrijving

Anthracyclines Adjuvant therapy | Anthracyclines Neoadjuvant Therapy | Doxorubicin Cumulative Dose | Epirubicin Cumulative Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0282564
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C0282564
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0013089
UMLS CUI [3,2]
C2986497
UMLS CUI [4,1]
C0014582
UMLS CUI [4,2]
C2986497
chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
Beschrijving

Adrenal Cortex Hormones chronic U/day | Methylprednisolone Equivalent | Exception Adrenal Cortex Hormones by Inhalation | Aspirin U/day | Clopidogrel U/day

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0025815
UMLS CUI [2,2]
C0205163
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0001617
UMLS CUI [3,3]
C0205535
UMLS CUI [4,1]
C0004057
UMLS CUI [4,2]
C0456683
UMLS CUI [5,1]
C0070166
UMLS CUI [5,2]
C0456683
clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
Beschrijving

Heart Disease | Cardiotoxicity During Prior Therapy | trastuzumab

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2,1]
C0876994
UMLS CUI [2,2]
C0347984
UMLS CUI [2,3]
C1514463
UMLS CUI [3]
C0728747
evidence of spinal cord compression or cns metastasis
Beschrijving

Compression of spinal cord | CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0037926
UMLS CUI [2]
C0686377
history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
Beschrijving

Cancer Other | Exception Disease Free Duration | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Skin carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0012634
UMLS CUI [2,3]
C0332296
UMLS CUI [2,4]
C0449238
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0699893
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Similar models

Eligibility Breast Cancer NCT00964704

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients, age >/=18 years
boolean
C0001779 (UMLS CUI [1])
HER2-positive carcinoma of breast Recurrent Locally | HER2-positive carcinoma of breast metastatic
Item
locally recurrent or metastatic her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C1517927 (UMLS CUI [1,3])
C1960398 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
Disease Progression During Adjuvant therapy | Disease Progression Post Adjuvant therapy | trastuzumab
Item
disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
boolean
C0242656 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C0677850 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0677850 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3])
Left ventricular ejection fraction
Item
lvef >/=55% at baseline
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
bevacizumab | capecitabine
Item
prior treatment with bevacizumab or capecitabine
boolean
C0796392 (UMLS CUI [1])
C0671970 (UMLS CUI [2])
Anthracyclines Adjuvant therapy | Anthracyclines Neoadjuvant Therapy | Doxorubicin Cumulative Dose | Epirubicin Cumulative Dose
Item
anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
boolean
C0282564 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0013089 (UMLS CUI [3,1])
C2986497 (UMLS CUI [3,2])
C0014582 (UMLS CUI [4,1])
C2986497 (UMLS CUI [4,2])
Adrenal Cortex Hormones chronic U/day | Methylprednisolone Equivalent | Exception Adrenal Cortex Hormones by Inhalation | Aspirin U/day | Clopidogrel U/day
Item
chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0025815 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0001617 (UMLS CUI [3,2])
C0205535 (UMLS CUI [3,3])
C0004057 (UMLS CUI [4,1])
C0456683 (UMLS CUI [4,2])
C0070166 (UMLS CUI [5,1])
C0456683 (UMLS CUI [5,2])
Heart Disease | Cardiotoxicity During Prior Therapy | trastuzumab
Item
clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
boolean
C0018799 (UMLS CUI [1])
C0876994 (UMLS CUI [2,1])
C0347984 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C0728747 (UMLS CUI [3])
Compression of spinal cord | CNS metastases
Item
evidence of spinal cord compression or cns metastasis
boolean
C0037926 (UMLS CUI [1])
C0686377 (UMLS CUI [2])
Cancer Other | Exception Disease Free Duration | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Skin carcinoma
Item
history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0012634 (UMLS CUI [2,2])
C0332296 (UMLS CUI [2,3])
C0449238 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0699893 (UMLS CUI [4,3])
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