ID

26884

Description

A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2-Positive Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00950300

Link

https://clinicaltrials.gov/show/NCT00950300

Keywords

Versions (1)
  1. 10/27/17 10/27/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 27, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00950300

English

Eligibility Breast Cancer NCT00950300

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult women >/= 18 years of age
Description

Adult | Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
non-metastatic primary invasive adenocarcinoma of the breast clinical stage i-iiic, including inflammatory and multicentric breast cancer, tumour size >/= 1 cm, histologically confirmed, her2-positive
Description

Breast adenocarcinoma Invasive Primary TNM Breast tumor staging | Inflammatory Breast Carcinoma | Multicentric Breast Carcinoma | Tumor size | HER2-positive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C0474926
UMLS CUI [2]
C0278601
UMLS CUI [3]
C2986664
UMLS CUI [4]
C0475440
UMLS CUI [5]
C1960398
at least 1 measurable lesion in breast or lymph nodes according to recist v1.0 criteria, except for inflammatory carcinoma
Description

Measurable lesion Quantity Breast | Measurable lesion Quantity Lymph nodes | Exception Inflammatory carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0006141
UMLS CUI [2,1]
C1513041
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0024204
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0334385
baseline lvef >/= 55%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of any prior (ipsi- and/or contralateral) invasive breast carcinoma
Description

Invasive carcinoma of breast Ipsilateral | Invasive carcinoma of breast Contralateral

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0441989
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0441988
past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix
Description

Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0851140
metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
any prior therapy with anthracyclines
Description

Anthracyclines

Data type

boolean

Alias
UMLS CUI [1]
C0282564
prior anti-her2 therapy or biologic or immunotherapy
Description

Therapeutic procedure HER2 Targeted | Biological treatment | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0242957
UMLS CUI [1,3]
C1521840
UMLS CUI [2]
C1531518
UMLS CUI [3]
C0021083
serious cardiac illness
Description

Heart Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT00950300

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age
Item
adult women >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
Breast adenocarcinoma Invasive Primary TNM Breast tumor staging | Inflammatory Breast Carcinoma | Multicentric Breast Carcinoma | Tumor size | HER2-positive carcinoma of breast
Item
non-metastatic primary invasive adenocarcinoma of the breast clinical stage i-iiic, including inflammatory and multicentric breast cancer, tumour size >/= 1 cm, histologically confirmed, her2-positive
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0474926 (UMLS CUI [1,4])
C0278601 (UMLS CUI [2])
C2986664 (UMLS CUI [3])
C0475440 (UMLS CUI [4])
C1960398 (UMLS CUI [5])
Measurable lesion Quantity Breast | Measurable lesion Quantity Lymph nodes | Exception Inflammatory carcinoma
Item
at least 1 measurable lesion in breast or lymph nodes according to recist v1.0 criteria, except for inflammatory carcinoma
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C1513041 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0024204 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0334385 (UMLS CUI [3,2])
Left ventricular ejection fraction
Item
baseline lvef >/= 55%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Invasive carcinoma of breast Ipsilateral | Invasive carcinoma of breast Contralateral
Item
history of any prior (ipsi- and/or contralateral) invasive breast carcinoma
boolean
C0853879 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0441988 (UMLS CUI [2,2])
Malignant Neoplasms | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Carcinoma in situ of uterine cervix
Item
past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0007117 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0851140 (UMLS CUI [4,3])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Anthracyclines
Item
any prior therapy with anthracyclines
boolean
C0282564 (UMLS CUI [1])
Therapeutic procedure HER2 Targeted | Biological treatment | Immunotherapy
Item
prior anti-her2 therapy or biologic or immunotherapy
boolean
C0087111 (UMLS CUI [1,1])
C0242957 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C1531518 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
Heart Disease Serious
Item
serious cardiac illness
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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