ID

27080

Description

Efficacy and Safety of DLBS1425 in Subjects With Advanced/Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01006785

Link

https://clinicaltrials.gov/show/NCT01006785

Keywords

Versions (1)
  1. 10/30/17 10/30/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 30, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01006785

English

Eligibility Breast Cancer NCT01006785

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects diagnosed with stage iiib or iv breast cancer who have failed with or refuse to receive standard chemotherapies
Description

Breast Carcinoma TNM Breast tumor staging | Chemotherapy failed | Chemotherapy Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0231175
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C1705116
subjects with the expression of er/pr negative; or positive er/pr expression but have failed with or refuse to receive hormonal therapy
Description

Receptor expression Estrogen receptor negative | Receptor expression Progesterone receptor negative | Receptor expression Estrogen receptor positive | Receptor expression Progesterone receptor positive | Hormone Therapy failed | Hormone Therapy Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0597360
UMLS CUI [1,2]
C0279756
UMLS CUI [2,1]
C0597360
UMLS CUI [2,2]
C0279766
UMLS CUI [3,1]
C0597360
UMLS CUI [3,2]
C0279754
UMLS CUI [4,1]
C0597360
UMLS CUI [4,2]
C0279759
UMLS CUI [5,1]
C0279025
UMLS CUI [5,2]
C0231175
UMLS CUI [6,1]
C0279025
UMLS CUI [6,2]
C1705116
either + or - expression of her-2/neu gene
Description

Gene Expression HER2/Neu Positive | Gene Expression HER2/Neu Negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0017262
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C0017262
UMLS CUI [2,2]
C2348908
ecog status = 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
at least have 1 evaluable and measurable metastatic lesion as defined by recist criteria
Description

Metastatic Lesion Evaluable Quantity | Metastatic Lesion Measurable Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513183
UMLS CUI [1,2]
C1516986
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1513183
UMLS CUI [2,2]
C1513040
UMLS CUI [2,3]
C1265611
adequate haematological, liver, and renal function
Description

Hematologic function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
at least 3 weeks has elapsed since prior chemotherapy, radiotherapy, biological/hormonal therapy
Description

Prior Chemotherapy Elapsed Time | Prior radiation therapy Elapsed Time | Biological treatment Previous Elapsed Time | Prior Hormone Therapy Elapsed Time

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C2826303
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C2826303
UMLS CUI [3,1]
C1531518
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C2826303
UMLS CUI [4,1]
C1514460
UMLS CUI [4,2]
C2826303
at least 4 weeks has elapsed since surgical biopsy / major surgery
Description

Surgical biopsy Elapsed Time | Major surgery Elapsed Time

Data type

boolean

Alias
UMLS CUI [1,1]
C0565118
UMLS CUI [1,2]
C2826303
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C2826303
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
allergic to the trial product
Description

Hypersensitivity Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
any other disease state, including infections or uncontrolled illnesses that could interfere with trial participation or trial evaluation
Description

Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Clinical Trial Evaluation | Communicable Diseases | Illness Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348568
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0008976
UMLS CUI [2,4]
C1261322
UMLS CUI [3]
C0009450
UMLS CUI [4,1]
C0221423
UMLS CUI [4,2]
C0205318
concurrent herbal (alternative) medicine or food supplements suspected to have effect on cancer disease
Description

Herbal medicine Suspected Effect Malignant Neoplasms | Food Supplements Suspected Effect Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1,1]
C2240391
UMLS CUI [1,2]
C0750491
UMLS CUI [1,3]
C1280500
UMLS CUI [1,4]
C0006826
UMLS CUI [2,1]
C0242295
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C1280500
UMLS CUI [2,4]
C0006826
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Similar models

Eligibility Breast Cancer NCT01006785

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma TNM Breast tumor staging | Chemotherapy failed | Chemotherapy Refused
Item
subjects diagnosed with stage iiib or iv breast cancer who have failed with or refuse to receive standard chemotherapies
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C1705116 (UMLS CUI [3,2])
Receptor expression Estrogen receptor negative | Receptor expression Progesterone receptor negative | Receptor expression Estrogen receptor positive | Receptor expression Progesterone receptor positive | Hormone Therapy failed | Hormone Therapy Refused
Item
subjects with the expression of er/pr negative; or positive er/pr expression but have failed with or refuse to receive hormonal therapy
boolean
C0597360 (UMLS CUI [1,1])
C0279756 (UMLS CUI [1,2])
C0597360 (UMLS CUI [2,1])
C0279766 (UMLS CUI [2,2])
C0597360 (UMLS CUI [3,1])
C0279754 (UMLS CUI [3,2])
C0597360 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
C0279025 (UMLS CUI [5,1])
C0231175 (UMLS CUI [5,2])
C0279025 (UMLS CUI [6,1])
C1705116 (UMLS CUI [6,2])
Gene Expression HER2/Neu Positive | Gene Expression HER2/Neu Negative
Item
either + or - expression of her-2/neu gene
boolean
C0017262 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0017262 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
ECOG performance status
Item
ecog status = 0-2
boolean
C1520224 (UMLS CUI [1])
Metastatic Lesion Evaluable Quantity | Metastatic Lesion Measurable Quantity
Item
at least have 1 evaluable and measurable metastatic lesion as defined by recist criteria
boolean
C1513183 (UMLS CUI [1,1])
C1516986 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1513183 (UMLS CUI [2,1])
C1513040 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Hematologic function | Liver function | Renal function
Item
adequate haematological, liver, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Prior Chemotherapy Elapsed Time | Prior radiation therapy Elapsed Time | Biological treatment Previous Elapsed Time | Prior Hormone Therapy Elapsed Time
Item
at least 3 weeks has elapsed since prior chemotherapy, radiotherapy, biological/hormonal therapy
boolean
C1514457 (UMLS CUI [1,1])
C2826303 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C2826303 (UMLS CUI [2,2])
C1531518 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C2826303 (UMLS CUI [3,3])
C1514460 (UMLS CUI [4,1])
C2826303 (UMLS CUI [4,2])
Surgical biopsy Elapsed Time | Major surgery Elapsed Time
Item
at least 4 weeks has elapsed since surgical biopsy / major surgery
boolean
C0565118 (UMLS CUI [1,1])
C2826303 (UMLS CUI [1,2])
C0679637 (UMLS CUI [2,1])
C2826303 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Investigational New Drugs
Item
allergic to the trial product
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Medical condition Interferes with Study Subject Participation Status | Medical condition Interferes with Clinical Trial Evaluation | Communicable Diseases | Illness Uncontrolled
Item
any other disease state, including infections or uncontrolled illnesses that could interfere with trial participation or trial evaluation
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C1261322 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3])
C0221423 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Herbal medicine Suspected Effect Malignant Neoplasms | Food Supplements Suspected Effect Malignant Neoplasms
Item
concurrent herbal (alternative) medicine or food supplements suspected to have effect on cancer disease
boolean
C2240391 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C1280500 (UMLS CUI [1,3])
C0006826 (UMLS CUI [1,4])
C0242295 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C1280500 (UMLS CUI [2,3])
C0006826 (UMLS CUI [2,4])
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