ID

19607

Description

Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00405938

Link

https://clinicaltrials.gov/show/NCT00405938

Keywords

Versions (1)
  1. 1/15/17 1/15/17 -
Uploaded on

January 15, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00405938

English

Eligibility Breast Cancer NCT00405938

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
postmenopausal breast cancer (adenocarcinoma) estrogen (er)and/or progesterone (pr) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed or with measurable and/or disease that is able to be assessed including isolated bone metastasis
Description

Breast adenocarcinoma Postmenopausal | Estrogen receptor positive | progesterone receptor positive | Locally advanced breast cancer | Breast cancer recurrent Local | Breast adenocarcinoma unresectable | Measurable Disease | Evaluable Disease | Secondary malignant neoplasm of bone Isolated

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0232970
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
UMLS CUI [4]
C3495949
UMLS CUI [5,1]
C0278493
UMLS CUI [5,2]
C0205276
UMLS CUI [6,1]
C0858252
UMLS CUI [6,2]
C1519810
UMLS CUI [7]
C1513041
UMLS CUI [8]
C1516986
UMLS CUI [9,1]
C0153690
UMLS CUI [9,2]
C0205409
female patients 18 years or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
documentation of er+ and/or pr+
Description

Estrogen receptor positive | progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2]
C0279759
no prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0346993
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0278493
UMLS CUI [3,3]
C0205276
UMLS CUI [3,4]
C0205187
UMLS CUI [4,1]
C0279025
UMLS CUI [4,2]
C0278493
UMLS CUI [4,3]
C0205276
UMLS CUI [4,4]
C0205187
UMLS CUI [5,1]
C0392920
UMLS CUI [5,2]
C3495949
UMLS CUI [5,3]
C0205187
UMLS CUI [6,1]
C0279025
UMLS CUI [6,2]
C3495949
UMLS CUI [6,3]
C0205187
measurable or evaluable disease
Description

Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.
Description

Therapeutic radiology procedure Bone lesion painful | Therapeutic radiology procedure Impending fracture | Measurable Disease | Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0238792
UMLS CUI [1,3]
C0030193
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C3665994
UMLS CUI [3]
C1513041
UMLS CUI [4]
C1516986
must have adequate bone marrow, renal and liver function
Description

Bone Marrow function | Renal function | Liver function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0232741
patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction
Description

Chemotherapy Anthracyclines Based | Left ventricular ejection fraction Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0282564
UMLS CUI [1,3]
C1705938
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
no metastatic disease to the central nervous system
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
no history of myocardial infarction (mi), stroke or transient ischemic attacks in the last 6 months
Description

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
no symptoms of peripheral vascular disease
Description

Peripheral Vascular Disease Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C1457887
no history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months
Description

abdominal fistula | Gastrointestinal perforation | Abdominal Abscess

Data type

boolean

Alias
UMLS CUI [1]
C1879311
UMLS CUI [2]
C0151664
UMLS CUI [3]
C0243001
no known hypersensitivity to phosphate, trehalose or polysorbate
Description

Hypersensitivity Phosphate | Hypersensitivity Trehalose | Hypersensitivity Polysorbates

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0031603
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0040815
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0032602
no serious non-healing wound, ulcer or bone fracture
Description

Non-healed Wound Serious | Ulcer Non-healing Serious | Fracture Non-healing Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0750433
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0041582
UMLS CUI [2,2]
C0205301
UMLS CUI [2,3]
C0205404
UMLS CUI [3,1]
C0016658
UMLS CUI [3,2]
C0205301
UMLS CUI [3,3]
C0205404
no uncontrolled high blood pressure or history of hypertensive crisis
Description

Uncontrolled hypertension | Hypertensive crisis

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0020546
no new york hear association class ii congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
no extensive cancer involvement of the liver or lungs
Description

Malignant Neoplasm Hepatic Involvement Extensive | Malignant Neoplasm Pulmonary involvement Extensive

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0441932
UMLS CUI [1,3]
C0205231
UMLS CUI [2,1]
C0006826
UMLS CUI [2,2]
C0748159
UMLS CUI [2,3]
C0205231
no history of significant psychiatric disorders
Description

Mental disorders Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0750502
no significant vascular disease
Description

Vascular Disease Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0042373
UMLS CUI [1,2]
C0750502
there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
Description

Clinical Trial Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Breast Cancer NCT00405938

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Postmenopausal | Estrogen receptor positive | progesterone receptor positive | Locally advanced breast cancer | Breast cancer recurrent Local | Breast adenocarcinoma unresectable | Measurable Disease | Evaluable Disease | Secondary malignant neoplasm of bone Isolated
Item
postmenopausal breast cancer (adenocarcinoma) estrogen (er)and/or progesterone (pr) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed or with measurable and/or disease that is able to be assessed including isolated bone metastasis
boolean
C0858252 (UMLS CUI [1,1])
C0232970 (UMLS CUI [1,2])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C3495949 (UMLS CUI [4])
C0278493 (UMLS CUI [5,1])
C0205276 (UMLS CUI [5,2])
C0858252 (UMLS CUI [6,1])
C1519810 (UMLS CUI [6,2])
C1513041 (UMLS CUI [7])
C1516986 (UMLS CUI [8])
C0153690 (UMLS CUI [9,1])
C0205409 (UMLS CUI [9,2])
Gender | Age
Item
female patients 18 years or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Estrogen receptor positive | progesterone receptor positive
Item
documentation of er+ and/or pr+
boolean
C0279754 (UMLS CUI [1])
C0279759 (UMLS CUI [2])
Chemotherapy Secondary malignant neoplasm of female breast | Hormone Therapy Secondary malignant neoplasm of female breast | Chemotherapy Breast cancer recurrent Local Inoperable | Hormone Therapy Breast cancer recurrent Local Inoperable | Chemotherapy Locally advanced breast cancer Inoperable | Hormone Therapy Locally advanced breast cancer Inoperable
Item
no prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced
boolean
C0392920 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0278493 (UMLS CUI [3,2])
C0205276 (UMLS CUI [3,3])
C0205187 (UMLS CUI [3,4])
C0279025 (UMLS CUI [4,1])
C0278493 (UMLS CUI [4,2])
C0205276 (UMLS CUI [4,3])
C0205187 (UMLS CUI [4,4])
C0392920 (UMLS CUI [5,1])
C3495949 (UMLS CUI [5,2])
C0205187 (UMLS CUI [5,3])
C0279025 (UMLS CUI [6,1])
C3495949 (UMLS CUI [6,2])
C0205187 (UMLS CUI [6,3])
Measurable Disease | Evaluable Disease
Item
measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Therapeutic radiology procedure Bone lesion painful | Therapeutic radiology procedure Impending fracture | Measurable Disease | Evaluable Disease
Item
radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.
boolean
C1522449 (UMLS CUI [1,1])
C0238792 (UMLS CUI [1,2])
C0030193 (UMLS CUI [1,3])
C1522449 (UMLS CUI [2,1])
C3665994 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3])
C1516986 (UMLS CUI [4])
Bone Marrow function | Renal function | Liver function
Item
must have adequate bone marrow, renal and liver function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2])
C0232741 (UMLS CUI [3])
Chemotherapy Anthracyclines Based | Left ventricular ejection fraction Normal
Item
patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction
boolean
C0392920 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C1705938 (UMLS CUI [1,3])
C0428772 (UMLS CUI [2,1])
C0205307 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
CNS metastases
Item
no metastatic disease to the central nervous system
boolean
C0686377 (UMLS CUI [1])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
no history of myocardial infarction (mi), stroke or transient ischemic attacks in the last 6 months
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Peripheral Vascular Disease Symptoms
Item
no symptoms of peripheral vascular disease
boolean
C0085096 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
abdominal fistula | Gastrointestinal perforation | Abdominal Abscess
Item
no history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months
boolean
C1879311 (UMLS CUI [1])
C0151664 (UMLS CUI [2])
C0243001 (UMLS CUI [3])
Hypersensitivity Phosphate | Hypersensitivity Trehalose | Hypersensitivity Polysorbates
Item
no known hypersensitivity to phosphate, trehalose or polysorbate
boolean
C0020517 (UMLS CUI [1,1])
C0031603 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0040815 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0032602 (UMLS CUI [3,2])
Non-healed Wound Serious | Ulcer Non-healing Serious | Fracture Non-healing Serious
Item
no serious non-healing wound, ulcer or bone fracture
boolean
C0750433 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0041582 (UMLS CUI [2,1])
C0205301 (UMLS CUI [2,2])
C0205404 (UMLS CUI [2,3])
C0016658 (UMLS CUI [3,1])
C0205301 (UMLS CUI [3,2])
C0205404 (UMLS CUI [3,3])
Uncontrolled hypertension | Hypertensive crisis
Item
no uncontrolled high blood pressure or history of hypertensive crisis
boolean
C1868885 (UMLS CUI [1])
C0020546 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
no new york hear association class ii congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Malignant Neoplasm Hepatic Involvement Extensive | Malignant Neoplasm Pulmonary involvement Extensive
Item
no extensive cancer involvement of the liver or lungs
boolean
C0006826 (UMLS CUI [1,1])
C0441932 (UMLS CUI [1,2])
C0205231 (UMLS CUI [1,3])
C0006826 (UMLS CUI [2,1])
C0748159 (UMLS CUI [2,2])
C0205231 (UMLS CUI [2,3])
Mental disorders Significant
Item
no history of significant psychiatric disorders
boolean
C0004936 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Vascular Disease Significant
Item
no significant vascular disease
boolean
C0042373 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Additional
Item
there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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