ID

37925

Beskrivning

Safety and Efficacy of INCB007839 With Trastuzumab and Vinorelbine in Patients With Metastatic HER2+ Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01254136

Länk

https://clinicaltrials.gov/show/NCT01254136

Nyckelord

Versioner (1)
  1. 2019-08-31 2019-08-31 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

31 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01254136

Engelsk

Eligibility Breast Cancer NCT01254136

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
Beskrivning

Secondary malignant neoplasm of female breast | Breast cancer recurrent Locally Inoperable

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C0278493
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C0205187
subject with histological her2+ status as determined by fish with a gene amplification score of ≥ 2.2
Beskrivning

HER2 Positive FISH | HER2 gene amplification Score

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348909
UMLS CUI [1,2]
C0162789
UMLS CUI [2,1]
C1512127
UMLS CUI [2,2]
C0449820
subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
Beskrivning

Availability of Biopsy tissue Primary tumor | Availability of Biopsy tissue Metastatic Lesion

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C3864006
UMLS CUI [1,3]
C0677930
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C3864006
UMLS CUI [2,3]
C1513183
subject with presence of measurable disease based on recist 1.1
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
subject who has received no more than three prior her2-directed therapeutic regimens for advanced breast cancer
Beskrivning

HER2 Targeted Therapy Quantity Advanced breast cancer

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C2985566
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C3495917
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject with left ventricular ejection fraction (lvef) below institutional normal range
Beskrivning

Left ventricular ejection fraction decreased

Datatyp

boolean

Alias
UMLS CUI [1]
C1096403
subject with metastasis to the central nervous system unless asymptomatic and clinically stable
Beskrivning

CNS metastases | Exception CNS metastases Asymptomatic Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0686377
UMLS CUI [2,3]
C0231221
UMLS CUI [2,4]
C0205360
subject with current active malignancy other than breast cancer
Beskrivning

Malignant Neoplasms | Exception Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
subject with prior history of other malignancy except for cancers from which the patient is currently disease free
Beskrivning

Cancer Other | Exception Malignant Neoplasm Disease Free

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0006826
UMLS CUI [2,3]
C0012634
UMLS CUI [2,4]
C0332296
subject with significant renal or hepatic dysfunction
Beskrivning

Renal dysfunction | Liver Dysfunction

Datatyp

boolean

Alias
UMLS CUI [1]
C3279454
UMLS CUI [2]
C0086565
subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
Beskrivning

Venous Thrombosis | Arterial thrombosis | Risk factor Thrombosis | Exception Malignant Neoplasms

Datatyp

boolean

Alias
UMLS CUI [1]
C0042487
UMLS CUI [2]
C0151942
UMLS CUI [3,1]
C0035648
UMLS CUI [3,2]
C0040053
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0006826
subject with insufficient bone marrow function
Beskrivning

Bone Marrow function Insufficient

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0231180
subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
Beskrivning

Medical contraindication Vinorelbine | Medical contraindication Trastuzumab | Medical contraindication Aspirin therapy | Medical contraindication Warfarin therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0078257
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0728747
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C4303556
UMLS CUI [4,1]
C1301624
UMLS CUI [4,2]
C4303340
subject with current active bacterial, hepatitis b or c, and/or hiv infections
Beskrivning

Bacterial Infections | Hepatitis B | Hepatitis C | HIV Infections

Datatyp

boolean

Alias
UMLS CUI [1]
C0004623
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
UMLS CUI [4]
C0019693
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Similar models

Eligibility Breast Cancer NCT01254136

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast | Breast cancer recurrent Locally Inoperable
Item
subject with diagnosis of metastatic (or locally recurrent-inoperable) breast cancer
boolean
C0346993 (UMLS CUI [1])
C0278493 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0205187 (UMLS CUI [2,3])
HER2 Positive FISH | HER2 gene amplification Score
Item
subject with histological her2+ status as determined by fish with a gene amplification score of ≥ 2.2
boolean
C2348909 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
Availability of Biopsy tissue Primary tumor | Availability of Biopsy tissue Metastatic Lesion
Item
subject with availability of archival biopsy tissue from primary tumor or metastatic lesions
boolean
C0470187 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
C0677930 (UMLS CUI [1,3])
C0470187 (UMLS CUI [2,1])
C3864006 (UMLS CUI [2,2])
C1513183 (UMLS CUI [2,3])
Measurable Disease
Item
subject with presence of measurable disease based on recist 1.1
boolean
C1513041 (UMLS CUI [1])
HER2 Targeted Therapy Quantity Advanced breast cancer
Item
subject who has received no more than three prior her2-directed therapeutic regimens for advanced breast cancer
boolean
C0069515 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C3495917 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Left ventricular ejection fraction decreased
Item
subject with left ventricular ejection fraction (lvef) below institutional normal range
boolean
C1096403 (UMLS CUI [1])
CNS metastases | Exception CNS metastases Asymptomatic Stable
Item
subject with metastasis to the central nervous system unless asymptomatic and clinically stable
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C0231221 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Malignant Neoplasms | Exception Breast Carcinoma
Item
subject with current active malignancy other than breast cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Cancer Other | Exception Malignant Neoplasm Disease Free
Item
subject with prior history of other malignancy except for cancers from which the patient is currently disease free
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0006826 (UMLS CUI [2,2])
C0012634 (UMLS CUI [2,3])
C0332296 (UMLS CUI [2,4])
Renal dysfunction | Liver Dysfunction
Item
subject with significant renal or hepatic dysfunction
boolean
C3279454 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
Venous Thrombosis | Arterial thrombosis | Risk factor Thrombosis | Exception Malignant Neoplasms
Item
subject with history of venous or arterial thrombosis or risk factor for thrombosis other than history of malignancy
boolean
C0042487 (UMLS CUI [1])
C0151942 (UMLS CUI [2])
C0035648 (UMLS CUI [3,1])
C0040053 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0006826 (UMLS CUI [4,2])
Bone Marrow function Insufficient
Item
subject with insufficient bone marrow function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
Medical contraindication Vinorelbine | Medical contraindication Trastuzumab | Medical contraindication Aspirin therapy | Medical contraindication Warfarin therapy
Item
subject with contraindication to vinorelbine, trastuzumab, aspirin and/or warfarin therapy.
boolean
C1301624 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C4303556 (UMLS CUI [3,2])
C1301624 (UMLS CUI [4,1])
C4303340 (UMLS CUI [4,2])
Bacterial Infections | Hepatitis B | Hepatitis C | HIV Infections
Item
subject with current active bacterial, hepatitis b or c, and/or hiv infections
boolean
C0004623 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
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