ID

19632

Description

Trastuzumab or Observation After Combination Chemotherapy and Trastuzumab in Treating Patients Undergoing Surgery for Stage II or Stage III Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00533936

Link

https://clinicaltrials.gov/show/NCT00533936

Keywords

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

January 17, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00533936

English

Eligibility Breast Cancer NCT00533936

1 forms  
Criteria
Description

Criteria

histologically confirmed invasive breast cancer by needle biopsy
Description

Invasive carcinoma of breast Needle biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0005560
diagnosed within the past 4 weeks
Description

Diagnosis Timepoint

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C2348792
clinical stage iib, iiia, iiib, or iiic disease
Description

Disease TNM clinical staging

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
palpable adenopathies present
Description

Lymphadenopathy Palpable

Data type

boolean

Alias
UMLS CUI [1,1]
C0497156
UMLS CUI [1,2]
C0522499
her2/neu-positive disease, as evidenced by either of the following:
Description

HER2-positive carcinoma of breast Evidence of

Data type

boolean

Alias
UMLS CUI [1,1]
C1960398
UMLS CUI [1,2]
C0332120
her2/neu overexpression (3+) by immunohistochemistry (ihc)
Description

ERBB2 Protein Overexpression Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0021044
her2/neu amplification by fluorescence in situ hybridization (fish)
Description

HER2 gene amplification Fluorescent in Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1,1]
C1512127
UMLS CUI [1,2]
C0162789
no metastatic disease by chest radiography, hepatic ultrasound, and bone scan (metastatic bone series if no nuclear medicine is available)
Description

Neoplasm Metastasis Plain chest X-ray | Ultrasonography of liver | Radioisotope scan of bone

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0039985
UMLS CUI [2]
C0412534
UMLS CUI [3]
C0203668
hormone receptor status:
Description

Hormone Receptor Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C0449438
estrogen receptor and/or progesterone receptor status known
Description

Estrogen Receptor Status Known | Progesterone Receptor Status Known

Data type

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205309
UMLS CUI [2,1]
C0034833
UMLS CUI [2,2]
C0449438
UMLS CUI [2,3]
C0205309
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
premenopausal or postmenopausal
Description

Premenopausal state | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2]
C0232970
who performance status 0-2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
not pregnant or nursing
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
normal hepatic, renal, and hematological function
Description

Liver function | Renal function | Hematologic function

Data type

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
UMLS CUI [3]
C0221130
lvef ≥ 55% by nuclear medicine study or echocardiogram
Description

Left ventricular ejection fraction Nuclear medicine procedure | Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0203634
UMLS CUI [2]
C0013516
no prior history of cancer, except carcinoma in situ of the cervix
Description

Malignant Neoplasms | Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0851140
no allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab (herceptin®)
Description

Paclitaxel allergy | Hypersensitivity trastuzumab | Hypersensitivity Herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0570707
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0728747
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0338204
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
no prior cancer therapy
Description

cancer treatment

Data type

boolean

Alias
UMLS CUI [1]
C0920425
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Similar models

Eligibility Breast Cancer NCT00533936

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Invasive carcinoma of breast Needle biopsy
Item
histologically confirmed invasive breast cancer by needle biopsy
boolean
C0853879 (UMLS CUI [1,1])
C0005560 (UMLS CUI [1,2])
Diagnosis Timepoint
Item
diagnosed within the past 4 weeks
boolean
C0011900 (UMLS CUI [1,1])
C2348792 (UMLS CUI [1,2])
Disease TNM clinical staging
Item
clinical stage iib, iiia, iiib, or iiic disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Lymphadenopathy Palpable
Item
palpable adenopathies present
boolean
C0497156 (UMLS CUI [1,1])
C0522499 (UMLS CUI [1,2])
HER2-positive carcinoma of breast Evidence of
Item
her2/neu-positive disease, as evidenced by either of the following:
boolean
C1960398 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
ERBB2 Protein Overexpression Immunohistochemistry
Item
her2/neu overexpression (3+) by immunohistochemistry (ihc)
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
HER2 gene amplification Fluorescent in Situ Hybridization
Item
her2/neu amplification by fluorescence in situ hybridization (fish)
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
Neoplasm Metastasis Plain chest X-ray | Ultrasonography of liver | Radioisotope scan of bone
Item
no metastatic disease by chest radiography, hepatic ultrasound, and bone scan (metastatic bone series if no nuclear medicine is available)
boolean
C0027627 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0412534 (UMLS CUI [2])
C0203668 (UMLS CUI [3])
Hormone Receptor Status
Item
hormone receptor status:
boolean
C0019929 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
Estrogen Receptor Status Known | Progesterone Receptor Status Known
Item
estrogen receptor and/or progesterone receptor status known
boolean
C0034804 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C0034833 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
C0205309 (UMLS CUI [2,3])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Premenopausal state | Postmenopausal state
Item
premenopausal or postmenopausal
boolean
C0232969 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
WHO performance status scale
Item
who performance status 0-2
boolean
C1298650 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
not pregnant or nursing
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver function | Renal function | Hematologic function
Item
normal hepatic, renal, and hematological function
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0221130 (UMLS CUI [3])
Left ventricular ejection fraction Nuclear medicine procedure | Echocardiography
Item
lvef ≥ 55% by nuclear medicine study or echocardiogram
boolean
C0428772 (UMLS CUI [1,1])
C0203634 (UMLS CUI [1,2])
C0013516 (UMLS CUI [2])
Malignant Neoplasms | Carcinoma in situ of uterine cervix
Item
no prior history of cancer, except carcinoma in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C0851140 (UMLS CUI [2])
Paclitaxel allergy | Hypersensitivity trastuzumab | Hypersensitivity Herceptin
Item
no allergic reaction or hypersensitivity to paclitaxel and/or trastuzumab (herceptin®)
boolean
C0570707 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
cancer treatment
Item
no prior cancer therapy
boolean
C0920425 (UMLS CUI [1])
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