ID

42608

Beschrijving

Open Label Trial of INCB07839 to Determine Effect and Safety of INCB007839 Plus Trastuzumab in HER2 Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00864175

Link

https://clinicaltrials.gov/show/NCT00864175

Trefwoorden

  1. 09-08-17 09-08-17 -
  2. 17-09-21 17-09-21 -
Geüploaded op

17 september 2021

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT00864175

Eligibility Metastatic Breast Cancer NCT00864175

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed metastatic breast carcinoma that is her2 positive
Beschrijving

Secondary malignant neoplasm of female breast HER2/Neu Positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C2348909
measurable disease as defined by the recist criteria
Beschrijving

Measurable Disease

Datatype

boolean

Alias
UMLS CUI [1]
C1513041
life expectancy greater than or equal to 6 months
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative oncology group (ecog) performance status of 0 or 1
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
received any anticancer medications in the 28 days prior to enrollment into this study
Beschrijving

Antineoplastic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0003392
received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
Beschrijving

Antineoplastic Agents | Breast Carcinoma Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C0003392
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C2828389
history of deep venous thrombosis within the last year
Beschrijving

Deep Vein Thrombosis

Datatype

boolean

Alias
UMLS CUI [1]
C0149871
contraindication to low dose warfarin therapy
Beschrijving

Medical contraindication Warfarin Low dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0043031
UMLS CUI [1,3]
C0445550
clinically significant cardiomyopathy
Beschrijving

Cardiomyopathy

Datatype

boolean

Alias
UMLS CUI [1]
C0878544
prior treatment with incb007839 or trastuzumab or lapatinib
Beschrijving

INCB007839 | trastuzumab | lapatinib

Datatype

boolean

Alias
UMLS CUI [1]
C4305800
UMLS CUI [2]
C0728747
UMLS CUI [3]
C1506770

Similar models

Eligibility Metastatic Breast Cancer NCT00864175

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast HER2/Neu Positive
Item
histologically or cytologically confirmed metastatic breast carcinoma that is her2 positive
boolean
C0346993 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Measurable Disease
Item
measurable disease as defined by the recist criteria
boolean
C1513041 (UMLS CUI [1])
Life Expectancy
Item
life expectancy greater than or equal to 6 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antineoplastic Agents
Item
received any anticancer medications in the 28 days prior to enrollment into this study
boolean
C0003392 (UMLS CUI [1])
Antineoplastic Agents | Breast Carcinoma Excluded
Item
received any anticancer medications for cancers other than breast cancer within 6 months prior to enrollment in this study.
boolean
C0003392 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Deep Vein Thrombosis
Item
history of deep venous thrombosis within the last year
boolean
C0149871 (UMLS CUI [1])
Medical contraindication Warfarin Low dose
Item
contraindication to low dose warfarin therapy
boolean
C1301624 (UMLS CUI [1,1])
C0043031 (UMLS CUI [1,2])
C0445550 (UMLS CUI [1,3])
Cardiomyopathy
Item
clinically significant cardiomyopathy
boolean
C0878544 (UMLS CUI [1])
INCB007839 | trastuzumab | lapatinib
Item
prior treatment with incb007839 or trastuzumab or lapatinib
boolean
C4305800 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C1506770 (UMLS CUI [3])

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