ID

33360

Descrição

A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.; ODM derived from: https://clinicaltrials.gov/show/NCT01290718

Link

https://clinicaltrials.gov/show/NCT01290718

Palavras-chave

  1. 06/12/2018 06/12/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de dezembro de 2018

DOI

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Licença

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01290718

Eligibility Breast Cancer NCT01290718

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, 18-65 years of age
Descrição

Gender | Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
histologically confirmed her2-positive breast cancer with measurable lesions (according to recist criteria)
Descrição

HER2-positive carcinoma of breast | Measurable lesion

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C1513041
metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with herceptin and taxanes
Descrição

Neoplasm Metastasis | Status post First line treatment | Recurrent disease Post Neoadjuvant Therapy | Recurrent disease Post Adjuvant therapy | Herceptin | Taxanes

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027627
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1708063
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C0687676
UMLS CUI [3,3]
C0600558
UMLS CUI [4,1]
C0277556
UMLS CUI [4,2]
C0687676
UMLS CUI [4,3]
C0677850
UMLS CUI [5]
C0338204
UMLS CUI [6]
C0796419
ecog performance status 0-2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
cns metastases which are not well controlled
Descrição

CNS metastases Poorly controlled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C3853134
simultaneous treatment with sorivudine
Descrição

sorivudine

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0207628
history of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
Descrição

Cancer Other | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [2,3]
C1880198
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1880198
pregnant or lactating women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

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

Similar models

Eligibility Breast Cancer NCT01290718

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, 18-65 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2-positive carcinoma of breast | Measurable lesion
Item
histologically confirmed her2-positive breast cancer with measurable lesions (according to recist criteria)
boolean
C1960398 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Neoplasm Metastasis | Status post First line treatment | Recurrent disease Post Neoadjuvant Therapy | Recurrent disease Post Adjuvant therapy | Herceptin | Taxanes
Item
metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with herceptin and taxanes
boolean
C0027627 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C1708063 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C0687676 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C0277556 (UMLS CUI [4,1])
C0687676 (UMLS CUI [4,2])
C0677850 (UMLS CUI [4,3])
C0338204 (UMLS CUI [5])
C0796419 (UMLS CUI [6])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS metastases Poorly controlled
Item
cns metastases which are not well controlled
boolean
C0686377 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
sorivudine
Item
simultaneous treatment with sorivudine
boolean
C0207628 (UMLS CUI [1])
Cancer Other | Exception Basal cell carcinoma Cured | Exception Carcinoma in situ of uterine cervix Cured
Item
history of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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