ID

20197

Description

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00300781

Lien

https://clinicaltrials.gov/show/NCT00300781

Mots-clés

  1. 11/02/2017 11/02/2017 -
Téléchargé le

11 février 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Breast Neoplasms NCT00300781

Eligibility Breast Neoplasms NCT00300781

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologic diagnosis of breast cancer and current stage iiib, iiic, or iv
Description

Breast cancer stage

Type de données

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0027646
progression following at least 6 weeks of standard doses of herceptin (arm a only)
Description

Herceptin

Type de données

boolean

Alias
UMLS CUI [1]
C0338204
over-expression of her2
Description

Over-expression of her2

Type de données

boolean

Alias
UMLS CUI [1]
C3812393
tumor tissue available and adequate for analysis at screening
Description

Tumor tissue sample

Type de données

boolean

Alias
UMLS CUI [1]
C0475358
at least one measurable lesion
Description

Measurable lesion

Type de données

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with herceptin (arm b only)
Description

Prior treatment with herceptin

Type de données

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0338204
more than 4 prior cytotoxic chemotherapy regimens
Description

Chemotherapy regimen

Type de données

boolean

Alias
UMLS CUI [1]
C0392920
subjects with bone or skin as the only site of measurable disease
Description

Bone or skin lesion

Type de données

boolean

Alias
UMLS CUI [1]
C0238792
UMLS CUI [2]
C0037284
inadequate cardiac function
Description

Cardiac function

Type de données

boolean

Alias
UMLS CUI [1]
C0232164
major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
Description

Prior treatment

Type de données

boolean

Alias
UMLS CUI [1]
C1514463
active central nervous system metastases
Description

Brain metastasis

Type de données

boolean

Alias
UMLS CUI [1]
C0220650
pregnant or breastfeeding women
Description

Gynaecological status

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inability to swallow the hki-272 capsules
Description

Swallowing problem

Type de données

boolean

Alias
UMLS CUI [1]
C0392678

Similar models

Eligibility Breast Neoplasms NCT00300781

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Breast cancer stage
Item
pathologic diagnosis of breast cancer and current stage iiib, iiic, or iv
boolean
C0678222 (UMLS CUI [1,1])
C0027646 (UMLS CUI [1,2])
Herceptin
Item
progression following at least 6 weeks of standard doses of herceptin (arm a only)
boolean
C0338204 (UMLS CUI [1])
Over-expression of her2
Item
over-expression of her2
boolean
C3812393 (UMLS CUI [1])
Tumor tissue sample
Item
tumor tissue available and adequate for analysis at screening
boolean
C0475358 (UMLS CUI [1])
Measurable lesion
Item
at least one measurable lesion
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior treatment with herceptin
Item
prior treatment with herceptin (arm b only)
boolean
C1514463 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
Chemotherapy regimen
Item
more than 4 prior cytotoxic chemotherapy regimens
boolean
C0392920 (UMLS CUI [1])
Bone or skin lesion
Item
subjects with bone or skin as the only site of measurable disease
boolean
C0238792 (UMLS CUI [1])
C0037284 (UMLS CUI [2])
Cardiac function
Item
inadequate cardiac function
boolean
C0232164 (UMLS CUI [1])
Prior treatment
Item
major surgery, chemotherapy, radiotherapy, investigational agents or other cancer therapy within 1 week of treatment day 1
boolean
C1514463 (UMLS CUI [1])
Brain metastasis
Item
active central nervous system metastases
boolean
C0220650 (UMLS CUI [1])
Gynaecological status
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Swallowing problem
Item
inability to swallow the hki-272 capsules
boolean
C0392678 (UMLS CUI [1])

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