ID

19693

Beschrijving

A Study of AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00356681

Link

https://clinicaltrials.gov/show/NCT00356681

Trefwoorden

Versies (1)
  1. 22-01-17 22-01-17 -
Geüploaded op

22 januari 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00356681

Engels

Eligibility Breast Neoplasms NCT00356681

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
Beschrijving

Breast adenocarcinoma | Recurrent disease Local | Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0205276
UMLS CUI [3]
C0027627
measurable disease by recist guidelines.
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
tumor (primary or metastatic) must be her2 negative.
Beschrijving

Human epidermal growth factor 2 negative carcinoma of breast Primary | Human epidermal growth factor 2 negative carcinoma of breast metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C2316304
UMLS CUI [1,2]
C0205225
UMLS CUI [2,1]
C2316304
UMLS CUI [2,2]
C1522484
adequate organ and hematologic function. exclusion:
Beschrijving

organ function | Hematologic function | Exclusion

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2]
C0221130
UMLS CUI [3]
C2828389
taxane treatment within 12 months prior to registration.
Beschrijving

taxane

Datatype

boolean

Alias
UMLS CUI [1]
C0215136
prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
Beschrijving

Chemotherapy Breast cancer recurrent Local | Chemotherapy Secondary malignant neoplasm of female breast | Hormone Therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0278493
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0346993
UMLS CUI [3]
C0279025
prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
Beschrijving

Therapeutic radiology procedure | Radiofrequency ablation | Cryosurgery Percutaneous | Chemoembolization of hepatic artery Measurable Disease Site All

Datatype

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0850292
UMLS CUI [3,1]
C0010408
UMLS CUI [3,2]
C0522523
UMLS CUI [4,1]
C2711393
UMLS CUI [4,2]
C1513041
UMLS CUI [4,3]
C1515974
UMLS CUI [4,4]
C0444868
current or prior history of central nervous system metastases.
Beschrijving

CNS metastases

Datatype

boolean

Alias
UMLS CUI [1]
C0686377
peripheral neuropathy ≥ grade 2 (ctcae v3.0) at registration.
Beschrijving

Peripheral Neuropathy CTCAE Grades

Datatype

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
history of arterial or venous thrombosis within 1 year prior to registration.
Beschrijving

Arterial thrombosis | Venous Thrombosis

Datatype

boolean

Alias
UMLS CUI [1]
C0151942
UMLS CUI [2]
C0042487
history of bleeding diathesis or bleeding within 14 days of registration.
Beschrijving

Bleeding tendency | Hemorrhage

Datatype

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0019080
uncontrolled hypertension (systolic >145 mmhg; diastolic >85 mmhg).
Beschrijving

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
clinically significant cardiac disease within 12 months of registration.
Beschrijving

Heart Disease Clinical Significance

Datatype

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C2826293
known hiv positive, hepatitis c positive or hepatitis b surface antigen positive.
Beschrijving

HIV Seropositivity | Hepatitis C positive | Hepatitis B surface antigen positive

Datatype

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C1112419
UMLS CUI [3]
C0149709
prior treatment with vegfr targeted therapies.
Beschrijving

Targeted Therapy VEGFR

Datatype

boolean

Alias
UMLS CUI [1,1]
C2985566
UMLS CUI [1,2]
C0148199
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Similar models

Eligibility Breast Neoplasms NCT00356681

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma | Recurrent disease Local | Neoplasm Metastasis
Item
histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease.
boolean
C0858252 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
Measurable Disease
Item
measurable disease by recist guidelines.
boolean
C1513041 (UMLS CUI [1])
Human epidermal growth factor 2 negative carcinoma of breast Primary | Human epidermal growth factor 2 negative carcinoma of breast metastatic
Item
tumor (primary or metastatic) must be her2 negative.
boolean
C2316304 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C2316304 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
organ function | Hematologic function | Exclusion
Item
adequate organ and hematologic function. exclusion:
boolean
C0678852 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
C2828389 (UMLS CUI [3])
taxane
Item
taxane treatment within 12 months prior to registration.
boolean
C0215136 (UMLS CUI [1])
Chemotherapy Breast cancer recurrent Local | Chemotherapy Secondary malignant neoplasm of female breast | Hormone Therapy
Item
prior chemotherapy for locally recurrent or metastatic breast cancer (prior endocrine therapy is permitted).
boolean
C0392920 (UMLS CUI [1,1])
C0278493 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3])
Therapeutic radiology procedure | Radiofrequency ablation | Cryosurgery Percutaneous | Chemoembolization of hepatic artery Measurable Disease Site All
Item
prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease.
boolean
C1522449 (UMLS CUI [1])
C0850292 (UMLS CUI [2])
C0010408 (UMLS CUI [3,1])
C0522523 (UMLS CUI [3,2])
C2711393 (UMLS CUI [4,1])
C1513041 (UMLS CUI [4,2])
C1515974 (UMLS CUI [4,3])
C0444868 (UMLS CUI [4,4])
CNS metastases
Item
current or prior history of central nervous system metastases.
boolean
C0686377 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy ≥ grade 2 (ctcae v3.0) at registration.
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Arterial thrombosis | Venous Thrombosis
Item
history of arterial or venous thrombosis within 1 year prior to registration.
boolean
C0151942 (UMLS CUI [1])
C0042487 (UMLS CUI [2])
Bleeding tendency | Hemorrhage
Item
history of bleeding diathesis or bleeding within 14 days of registration.
boolean
C1458140 (UMLS CUI [1])
C0019080 (UMLS CUI [2])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
uncontrolled hypertension (systolic >145 mmhg; diastolic >85 mmhg).
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Heart Disease Clinical Significance
Item
clinically significant cardiac disease within 12 months of registration.
boolean
C0018799 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
HIV Seropositivity | Hepatitis C positive | Hepatitis B surface antigen positive
Item
known hiv positive, hepatitis c positive or hepatitis b surface antigen positive.
boolean
C0019699 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
C0149709 (UMLS CUI [3])
Targeted Therapy VEGFR
Item
prior treatment with vegfr targeted therapies.
boolean
C2985566 (UMLS CUI [1,1])
C0148199 (UMLS CUI [1,2])
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