ID

43633

Description

Lapatinib Resistance in Patients With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00898573

Link

https://clinicaltrials.gov/show/NCT00898573

Keywords

Versions (2)
  1. 10/25/17 10/25/17 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00898573

English

Eligibility Breast Cancer NCT00898573

1 forms  
Criteria
Description

Criteria

pathologically confirmed invasive breast cancer
Description

Invasive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C0853879
erbb2-positive disease
Description

Disease HER2/Neu Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
has received or is currently receiving lapatinib ditosylate
Description

lapatinib ditosylate

Data type

boolean

Alias
UMLS CUI [1]
C1504917
documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration or a radiographic response)
Description

lapatinib ditosylate | Benefit Clinical | Stable Disease | Response Radiography

Data type

boolean

Alias
UMLS CUI [1]
C1504917
UMLS CUI [2,1]
C0814225
UMLS CUI [2,2]
C0205210
UMLS CUI [3]
C0677946
UMLS CUI [4,1]
C1704632
UMLS CUI [4,2]
C0034571
must have tumor tissue samples available for research studies
Description

Tumor tissue sample Available Research study

Data type

boolean

Alias
UMLS CUI [1,1]
C0475358
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0681814
hormone receptor status not specified
Description

Hormone Receptor Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205370
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
menopausal status not specified
Description

Menopausal Status Unspecified

Data type

boolean

Alias
UMLS CUI [1,1]
C3829127
UMLS CUI [1,2]
C0205370
not pregnant*
Description

Pregnancy Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C0332197
coagulation profile normal*
Description

Coagulation profile Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0005790
UMLS CUI [1,2]
C0205307
platelet count > 100,000/mm³* note: *for patients requiring a post-treatment biopsy
Description

Platelet Count measurement | Biopsy post treatment Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0032181
UMLS CUI [2,1]
C0005558
UMLS CUI [2,2]
C2709088
UMLS CUI [2,3]
C0686904
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
see disease characteristics
Description

ID.13

Data type

boolean

concurrent chemotherapy or trastuzumab (herceptin®) allowed
Description

Chemotherapy | trastuzumab | Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0338204
no concurrent anticoagulants, including warfarin or low-molecular weight heparin*
Description

Exclusion Criteria | Anticoagulants | Warfarin | Heparin, Low-Molecular-Weight

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0003280
UMLS CUI [3]
C0043031
UMLS CUI [4]
C0019139
no concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* note: *for patients requiring a post-treatment biopsy
Description

Exclusion Criteria | Antiplatelet therapy | Aspirin | clopidogrel | Antiplatelet Agents | Biopsy post treatment Patient need for

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1096021
UMLS CUI [3]
C0004057
UMLS CUI [4]
C0070166
UMLS CUI [5]
C0085826
UMLS CUI [6,1]
C0005558
UMLS CUI [6,2]
C2709088
UMLS CUI [6,3]
C0686904
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Similar models

Eligibility Breast Cancer NCT00898573

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Invasive carcinoma of breast
Item
pathologically confirmed invasive breast cancer
boolean
C0853879 (UMLS CUI [1])
Disease HER2/Neu Positive
Item
erbb2-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
lapatinib ditosylate
Item
has received or is currently receiving lapatinib ditosylate
boolean
C1504917 (UMLS CUI [1])
lapatinib ditosylate | Benefit Clinical | Stable Disease | Response Radiography
Item
documented clinical benefit while receiving lapatinib ditosylate (e.g., stable disease of ≥ 12 weeks duration or a radiographic response)
boolean
C1504917 (UMLS CUI [1])
C0814225 (UMLS CUI [2,1])
C0205210 (UMLS CUI [2,2])
C0677946 (UMLS CUI [3])
C1704632 (UMLS CUI [4,1])
C0034571 (UMLS CUI [4,2])
Tumor tissue sample Available Research study
Item
must have tumor tissue samples available for research studies
boolean
C0475358 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0681814 (UMLS CUI [1,3])
Hormone Receptor Status Unspecified
Item
hormone receptor status not specified
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205370 (UMLS CUI [1,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Menopausal Status Unspecified
Item
menopausal status not specified
boolean
C3829127 (UMLS CUI [1,1])
C0205370 (UMLS CUI [1,2])
Pregnancy Absent
Item
not pregnant*
boolean
C0032961 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Coagulation profile Normal
Item
coagulation profile normal*
boolean
C0005790 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Platelet Count measurement | Biopsy post treatment Patient need for
Item
platelet count > 100,000/mm³* note: *for patients requiring a post-treatment biopsy
boolean
C0032181 (UMLS CUI [1])
C0005558 (UMLS CUI [2,1])
C2709088 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
ID.13
Item
see disease characteristics
boolean
Chemotherapy | trastuzumab | Herceptin
Item
concurrent chemotherapy or trastuzumab (herceptin®) allowed
boolean
C0392920 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C0338204 (UMLS CUI [3])
Exclusion Criteria | Anticoagulants | Warfarin | Heparin, Low-Molecular-Weight
Item
no concurrent anticoagulants, including warfarin or low-molecular weight heparin*
boolean
C0680251 (UMLS CUI [1])
C0003280 (UMLS CUI [2])
C0043031 (UMLS CUI [3])
C0019139 (UMLS CUI [4])
Exclusion Criteria | Antiplatelet therapy | Aspirin | clopidogrel | Antiplatelet Agents | Biopsy post treatment Patient need for
Item
no concurrent antiplatelet therapy, including aspirin, clopidogrel, or other antiplatelet agents* note: *for patients requiring a post-treatment biopsy
boolean
C0680251 (UMLS CUI [1])
C1096021 (UMLS CUI [2])
C0004057 (UMLS CUI [3])
C0070166 (UMLS CUI [4])
C0085826 (UMLS CUI [5])
C0005558 (UMLS CUI [6,1])
C2709088 (UMLS CUI [6,2])
C0686904 (UMLS CUI [6,3])
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