ID

38050

Beschrijving

Ruxolitinib in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01562873

Link

https://clinicaltrials.gov/show/NCT01562873

Trefwoorden

Versies (1)
  1. 12-09-19 12-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 september 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01562873

Engels

Eligibility Breast Cancer NCT01562873

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive breast cancer
Beschrijving

Invasive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1]
C0853879
must have known er, pr and her2 status
Beschrijving

Estrogen Receptor Status Known | Progesterone Receptor Status Known | HER2 Status Known

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516974
UMLS CUI [1,2]
C0205309
UMLS CUI [2,1]
C1514471
UMLS CUI [2,2]
C0205309
UMLS CUI [3,1]
C1512413
UMLS CUI [3,2]
C0205309
either, triple negative metastatic breast cancer or
Beschrijving

Triple Negative Breast Neoplasm metastatic

Datatype

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C1522484
inflammatory breast cancer with any er, pr her2 status
Beschrijving

Inflammatory Breast Carcinoma | Estrogen Receptor Status Any | Progesterone Receptor Status Any | HER2 Status Any

Datatype

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2,1]
C1516974
UMLS CUI [2,2]
C1552551
UMLS CUI [3,1]
C1514471
UMLS CUI [3,2]
C1552551
UMLS CUI [4,1]
C1512413
UMLS CUI [4,2]
C1552551
availability of archival tissue specimen suitable for pstat3 testing
Beschrijving

Availability of Tissue specimen | Other Coding | STAT3 Testing

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1292533
UMLS CUI [2]
C3846158
UMLS CUI [3,1]
C1367307
UMLS CUI [3,2]
C0039593
life expectancy of greater than 3 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
measurable disease by recist
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
at least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or
Beschrijving

Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast | Recurrence | Neoadjuvant Chemotherapy Completion | Adjuvant Chemotherapy Completion

Datatype

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
UMLS CUI [2]
C0034897
UMLS CUI [3,1]
C0600558
UMLS CUI [3,2]
C3665472
UMLS CUI [3,3]
C0205197
UMLS CUI [4,1]
C0085533
UMLS CUI [4,2]
C0205197
for patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required
Beschrijving

Inflammatory Breast Carcinoma | Distant metastasis Absent | Progression | Etiology Neoadjuvant Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0449258
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C3665472
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding
Beschrijving

Pregnancy | Breast Feeding

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active brain metastases
Beschrijving

Metastatic malignant neoplasm to brain

Datatype

boolean

Alias
UMLS CUI [1]
C0220650
history of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib
Beschrijving

Allergic Reaction Ruxolitinib Compound Similar

Datatype

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C2931926
UMLS CUI [1,3]
C1706082
UMLS CUI [1,4]
C2348205
clinically significant malabsorption syndrome
Beschrijving

Malabsorption Syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0024523
concurrent use of medications/substances that are strong inhibitors of cy3a4
Beschrijving

CYP3A4 Inhibitors Strong

Datatype

boolean

Alias
UMLS CUI [1,1]
C3850053
UMLS CUI [1,2]
C0442821
no uncontrolled intercurrent illness
Beschrijving

Comorbidity Uncontrolled

Datatype

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
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Similar models

Eligibility Breast Cancer NCT01562873

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
histologically or cytologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Estrogen Receptor Status Known | Progesterone Receptor Status Known | HER2 Status Known
Item
must have known er, pr and her2 status
boolean
C1516974 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
C1514471 (UMLS CUI [2,1])
C0205309 (UMLS CUI [2,2])
C1512413 (UMLS CUI [3,1])
C0205309 (UMLS CUI [3,2])
Triple Negative Breast Neoplasm metastatic
Item
either, triple negative metastatic breast cancer or
boolean
C3539878 (UMLS CUI [1,1])
C1522484 (UMLS CUI [1,2])
Inflammatory Breast Carcinoma | Estrogen Receptor Status Any | Progesterone Receptor Status Any | HER2 Status Any
Item
inflammatory breast cancer with any er, pr her2 status
boolean
C0278601 (UMLS CUI [1])
C1516974 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C1514471 (UMLS CUI [3,1])
C1552551 (UMLS CUI [3,2])
C1512413 (UMLS CUI [4,1])
C1552551 (UMLS CUI [4,2])
Availability of Tissue specimen | Other Coding | STAT3 Testing
Item
availability of archival tissue specimen suitable for pstat3 testing
boolean
C0470187 (UMLS CUI [1,1])
C1292533 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
C1367307 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
Measurable Disease
Item
measurable disease by recist
boolean
C1513041 (UMLS CUI [1])
Prior Chemotherapy Quantity Secondary malignant neoplasm of female breast | Recurrence | Neoadjuvant Chemotherapy Completion | Adjuvant Chemotherapy Completion
Item
at least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C0034897 (UMLS CUI [2])
C0600558 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0085533 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
Inflammatory Breast Carcinoma | Distant metastasis Absent | Progression | Etiology Neoadjuvant Chemotherapy
Item
for patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required
boolean
C0278601 (UMLS CUI [1])
C1269798 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0449258 (UMLS CUI [3])
C0015127 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C3665472 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
active brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Ruxolitinib Compound Similar
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib
boolean
C1527304 (UMLS CUI [1,1])
C2931926 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
Malabsorption Syndrome
Item
clinically significant malabsorption syndrome
boolean
C0024523 (UMLS CUI [1])
CYP3A4 Inhibitors Strong
Item
concurrent use of medications/substances that are strong inhibitors of cy3a4
boolean
C3850053 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
Comorbidity Uncontrolled
Item
no uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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