ID

16449

Description

Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00270894

Link

https://clinicaltrials.gov/show/NCT00270894

Keywords

Versions (1)
  1. 7/17/16 7/17/16 -
Uploaded on

July 17, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasm NCT00270894

English

Eligibility Breast Neoplasm NCT00270894

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
non-pregnant females =/> 18 years of age
Description

not pregnant, age

Data type

boolean

Alias
UMLS CUI [1]
C0232973
UMLS CUI [2]
C0001779
non-inflammatory breast cancer stage iia - iiic or high risk node negative
Description

non-inflammatory breast cancer stage iia - iiic or high risk node negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0442743
UMLS CUI [2]
C2216702
UMLS CUI [3]
C3160889
core biopsy of breast demonstrating invasive cancer and documented er/pgr receptor status
Description

invasive cancer and documented er/pgr receptor status

Data type

boolean

Alias
UMLS CUI [1,1]
C0842740
UMLS CUI [1,2]
C0853879
UMLS CUI [2]
C2021584
UMLS CUI [3]
C2239069
normal cardiac function and adequate hematologic function
Description

cardiac and hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0221130
human epidermal growth factor receptor 2 protein (her2) positive
Description

her2 positive

Data type

boolean

Alias
UMLS CUI [1]
C1960398
no evidence of metastatic disease
Description

metastatic disease

Data type

boolean

Alias
UMLS CUI [1]
C2939420
ecog performance status 0 - 1
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
treated with other investigational drugs within 30 days
Description

investigational drug application

Data type

boolean

Alias
UMLS CUI [1]
C0162778
uncontrolled intercurrent disease or active infection
Description

intercurrent disease or infection

Data type

boolean

Alias
UMLS CUI [1]
C0277557
UMLS CUI [2]
C0240021
known sensitivity to e. coli-derived proteins or polysorbate 80
Description

sensitivity to e. coli-derived proteins or polysorbate 80

Data type

boolean

Alias
UMLS CUI [1,1]
C0332324
UMLS CUI [1,2]
C0014834
UMLS CUI [1,3]
C0004627
UMLS CUI [2,1]
C0332324
UMLS CUI [2,2]
C0032601
psychiatric illness or social situation that would limit study compliance
Description

psychiatric illness or social situation that would limit study compliance

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0748872
UMLS CUI [3]
C1321605
pre-existing peripheral neuropathy > grade 1
Description

peripheral neuropathy

Data type

boolean

Alias
UMLS CUI [1]
C0031117
cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
Description

cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast

Data type

boolean

Alias
UMLS CUI [1]
C1882062
UMLS CUI [2]
C0009488
bilateral synchronous breast cancer
Description

bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0281267
inflammatory breast cancer
Description

inflammatory breast cancer

Data type

boolean

Alias
UMLS CUI [1]
C0278601
women who are pregnant or breast feeding
Description

pregnant or breast feeding

Data type

boolean

Alias
UMLS CUI [1]
C0549206
UMLS CUI [2]
C1623040
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Similar models

Eligibility Breast Neoplasm NCT00270894

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
not pregnant, age
Item
non-pregnant females =/> 18 years of age
boolean
C0232973 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
non-inflammatory breast cancer stage iia - iiic or high risk node negative
Item
non-inflammatory breast cancer stage iia - iiic or high risk node negative
boolean
C0006142 (UMLS CUI [1,1])
C0442743 (UMLS CUI [1,2])
C2216702 (UMLS CUI [2])
C3160889 (UMLS CUI [3])
invasive cancer and documented er/pgr receptor status
Item
core biopsy of breast demonstrating invasive cancer and documented er/pgr receptor status
boolean
C0842740 (UMLS CUI [1,1])
C0853879 (UMLS CUI [1,2])
C2021584 (UMLS CUI [2])
C2239069 (UMLS CUI [3])
cardiac and hematologic function
Item
normal cardiac function and adequate hematologic function
boolean
C0232164 (UMLS CUI [1])
C0221130 (UMLS CUI [2])
her2 positive
Item
human epidermal growth factor receptor 2 protein (her2) positive
boolean
C1960398 (UMLS CUI [1])
metastatic disease
Item
no evidence of metastatic disease
boolean
C2939420 (UMLS CUI [1])
ecog performance status
Item
ecog performance status 0 - 1
boolean
C1520224 (UMLS CUI [1])
contraception
Item
women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment
boolean
C3831118 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
investigational drug application
Item
treated with other investigational drugs within 30 days
boolean
C0162778 (UMLS CUI [1])
intercurrent disease or infection
Item
uncontrolled intercurrent disease or active infection
boolean
C0277557 (UMLS CUI [1])
C0240021 (UMLS CUI [2])
sensitivity to e. coli-derived proteins or polysorbate 80
Item
known sensitivity to e. coli-derived proteins or polysorbate 80
boolean
C0332324 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
C0004627 (UMLS CUI [1,3])
C0332324 (UMLS CUI [2,1])
C0032601 (UMLS CUI [2,2])
psychiatric illness or social situation that would limit study compliance
Item
psychiatric illness or social situation that would limit study compliance
boolean
C0004936 (UMLS CUI [1])
C0748872 (UMLS CUI [2])
C1321605 (UMLS CUI [3])
peripheral neuropathy
Item
pre-existing peripheral neuropathy > grade 1
boolean
C0031117 (UMLS CUI [1])
cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
Item
cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
boolean
C1882062 (UMLS CUI [1])
C0009488 (UMLS CUI [2])
bilateral breast cancer
Item
bilateral synchronous breast cancer
boolean
C0281267 (UMLS CUI [1])
inflammatory breast cancer
Item
inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
pregnant or breast feeding
Item
women who are pregnant or breast feeding
boolean
C0549206 (UMLS CUI [1])
C1623040 (UMLS CUI [2])
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