ID

21845

Description

Androgen Therapy for Management of Estrogen/Progesterone Receptor Negative ER(-)PR(-) Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00303615

Link

https://clinicaltrials.gov/show/NCT00303615

Keywords

Versions (1)
  1. 5/3/17 5/3/17 -
Uploaded on

May 3, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00303615

English

Eligibility Metastatic Breast Cancer NCT00303615

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
over 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
er negative and pr negative
Description

Estrogen receptor negative | Progesterone receptor negative

Data type

boolean

Alias
UMLS CUI [1]
C0279756
UMLS CUI [2]
C0279766
progression of disease in the metastatic setting despite taxane or other chemotherapeutic therapies including herceptin (patients on herceptin may continue this therapy while on study)
Description

Neoplasm Metastasis | Disease Progression | taxane | Chemotherapeutic Agents | Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0215136
UMLS CUI [4]
C0003392
UMLS CUI [5]
C0338204
maximized chemotherapy in the metastatic setting or patient experienced side effects contributing to decreased quality of life and elects to defer chemotherapy
Description

Chemotherapy Maximal Neoplasm Metastasis | Side effects Resulting in Quality of life decreased

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0205289
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0879626
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C1963786
evaluable disease by either:
Description

Evaluable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1516986
ct scan with or without contrast (lesions must be greater than 2 mm)
Description

X-Ray Computed Tomography | ct scan contrast | Lesion size

Data type

boolean

Alias
UMLS CUI [1]
C0040405
UMLS CUI [2]
C0742919
UMLS CUI [3]
C0449453
pet scan, or bone scan, or plain skeletal films
Description

Positron-Emission Tomography | Bone scan | X-Ray Film Whole skeleton

Data type

boolean

Alias
UMLS CUI [1]
C0032743
UMLS CUI [2]
C0203668
UMLS CUI [3,1]
C0043303
UMLS CUI [3,2]
C1317935
chest wall or skin recurrence (digital photo to capture evaluable disease)
Description

Chest wall Disease recurrence | Skin Disease recurrence | Evaluable Disease Digital X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C1279035
UMLS CUI [1,2]
C0679254
UMLS CUI [2,1]
C1123023
UMLS CUI [2,2]
C0679254
UMLS CUI [3,1]
C1516986
UMLS CUI [3,2]
C0442015
evaluable symptoms (pain, shortness of breath, fatigue, anorexia)
Description

Symptoms Evaluable | Pain | Dyspnea | Fatigue | Anorexia

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C1516986
UMLS CUI [2]
C0030193
UMLS CUI [3]
C0013404
UMLS CUI [4]
C0015672
UMLS CUI [5]
C0003123
performance status of 0, 1, or 2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
bilateral mammogram performed within one year before registration
Description

Bilateral mammography

Data type

boolean

Alias
UMLS CUI [1]
C0203027
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
uncontrolled hypercalcemia greater than 11
Description

Hypercalcemia Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0020437
UMLS CUI [1,2]
C0205318
uncontrolled congestive heart failure greater than 2 nyha class
Description

Congestive heart failure Uncontrolled New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C1275491
central nervous system metastasis
Description

CNS metastases

Data type

boolean

Alias
UMLS CUI [1]
C0686377
concomitant steroid use
Description

steroid use

Data type

boolean

Alias
UMLS CUI [1]
C0281991
performance status of greater than 2
Description

performance status

Data type

boolean

Alias
UMLS CUI [1]
C1518965
bilirubin greater than 5.5
Description

Serum total bilirubin measurement

Data type

boolean

Alias
UMLS CUI [1]
C1278039
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Similar models

Eligibility Metastatic Breast Cancer NCT00303615

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
over 18 years of age
boolean
C0001779 (UMLS CUI [1])
Estrogen receptor negative | Progesterone receptor negative
Item
er negative and pr negative
boolean
C0279756 (UMLS CUI [1])
C0279766 (UMLS CUI [2])
Neoplasm Metastasis | Disease Progression | taxane | Chemotherapeutic Agents | Herceptin
Item
progression of disease in the metastatic setting despite taxane or other chemotherapeutic therapies including herceptin (patients on herceptin may continue this therapy while on study)
boolean
C0027627 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
C0003392 (UMLS CUI [4])
C0338204 (UMLS CUI [5])
Chemotherapy Maximal Neoplasm Metastasis | Side effects Resulting in Quality of life decreased
Item
maximized chemotherapy in the metastatic setting or patient experienced side effects contributing to decreased quality of life and elects to defer chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C0205289 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0879626 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C1963786 (UMLS CUI [2,3])
Evaluable Disease
Item
evaluable disease by either:
boolean
C1516986 (UMLS CUI [1])
X-Ray Computed Tomography | ct scan contrast | Lesion size
Item
ct scan with or without contrast (lesions must be greater than 2 mm)
boolean
C0040405 (UMLS CUI [1])
C0742919 (UMLS CUI [2])
C0449453 (UMLS CUI [3])
Positron-Emission Tomography | Bone scan | X-Ray Film Whole skeleton
Item
pet scan, or bone scan, or plain skeletal films
boolean
C0032743 (UMLS CUI [1])
C0203668 (UMLS CUI [2])
C0043303 (UMLS CUI [3,1])
C1317935 (UMLS CUI [3,2])
Chest wall Disease recurrence | Skin Disease recurrence | Evaluable Disease Digital X-ray
Item
chest wall or skin recurrence (digital photo to capture evaluable disease)
boolean
C1279035 (UMLS CUI [1,1])
C0679254 (UMLS CUI [1,2])
C1123023 (UMLS CUI [2,1])
C0679254 (UMLS CUI [2,2])
C1516986 (UMLS CUI [3,1])
C0442015 (UMLS CUI [3,2])
Symptoms Evaluable | Pain | Dyspnea | Fatigue | Anorexia
Item
evaluable symptoms (pain, shortness of breath, fatigue, anorexia)
boolean
C1457887 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
C0030193 (UMLS CUI [2])
C0013404 (UMLS CUI [3])
C0015672 (UMLS CUI [4])
C0003123 (UMLS CUI [5])
performance status
Item
performance status of 0, 1, or 2
boolean
C1518965 (UMLS CUI [1])
Bilateral mammography
Item
bilateral mammogram performed within one year before registration
boolean
C0203027 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Hypercalcemia Uncontrolled
Item
uncontrolled hypercalcemia greater than 11
boolean
C0020437 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Congestive heart failure Uncontrolled New York Heart Association Classification
Item
uncontrolled congestive heart failure greater than 2 nyha class
boolean
C0018802 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
CNS metastases
Item
central nervous system metastasis
boolean
C0686377 (UMLS CUI [1])
steroid use
Item
concomitant steroid use
boolean
C0281991 (UMLS CUI [1])
performance status
Item
performance status of greater than 2
boolean
C1518965 (UMLS CUI [1])
Serum total bilirubin measurement
Item
bilirubin greater than 5.5
boolean
C1278039 (UMLS CUI [1])
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