ID

12959

Description

Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2/Neu Overexpression; ODM derived from: https://clinicaltrials.gov/show/NCT00033514

Link

https://clinicaltrials.gov/show/NCT00033514

Keywords

  1. 1/7/16 1/7/16 -
Uploaded on

January 7, 2016

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00033514

Eligibility Breast Cancer NCT00033514

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women aged > 18 years
Description

age, gender

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0079399
histologically documents metastatic breast cancer
Description

histology metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0027627
her2 positive using fish
Description

FISH her2 positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0162789
UMLS CUI [1,2]
C0242957
for phase i, patients who have previously received treatment for their metastatic disease are allowed to participate.
Description

previous treatment

Data type

boolean

Alias
UMLS CUI [1]
C0087111
for the phase ii portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral ct scan)
Description

measureable disease

Data type

boolean

Alias
UMLS CUI [1]
C0475440
UMLS CUI [2]
C0860888
ecog performance status of 0 to 2
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
a life expectancy of > 3 months
Description

life expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
use of effective means of contraception
Description

contraception

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
for phase ii, prior cytotoxic chemotherapy and/or prior herceptin for their metastatic disease. prior treatment in the adjuvant setting is allowed.
Description

chemotherapy, herceptin

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0338204

Similar models

Eligibility Breast Cancer NCT00033514

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
age, gender
Item
women aged > 18 years
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
histology metastasis
Item
histologically documents metastatic breast cancer
boolean
C0019638 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
FISH her2 positive
Item
her2 positive using fish
boolean
C0162789 (UMLS CUI [1,1])
C0242957 (UMLS CUI [1,2])
previous treatment
Item
for phase i, patients who have previously received treatment for their metastatic disease are allowed to participate.
boolean
C0087111 (UMLS CUI [1])
measureable disease
Item
for the phase ii portion of the study, patients must have measureable disease (> 2 cm; > 1 cm on spiral ct scan)
boolean
C0475440 (UMLS CUI [1])
C0860888 (UMLS CUI [2])
ecog performance status
Item
ecog performance status of 0 to 2
boolean
C1520224 (UMLS CUI [1])
life expectancy
Item
a life expectancy of > 3 months
boolean
C0023671 (UMLS CUI [1])
contraception
Item
use of effective means of contraception
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
chemotherapy, herceptin
Item
for phase ii, prior cytotoxic chemotherapy and/or prior herceptin for their metastatic disease. prior treatment in the adjuvant setting is allowed.
boolean
C0392920 (UMLS CUI [1])
C0338204 (UMLS CUI [2])

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