Information:
Error:
ID
20197
Description
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00300781
Link
https://clinicaltrials.gov/show/NCT00300781
Keywords
Versions (1)
- 2/11/17 2/11/17 -
Uploaded on
February 11, 2017
DOI
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License
Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT00300781
Eligibility Breast Neoplasms NCT00300781
- StudyEvent: Eligibility
Similar models
Eligibility Breast Neoplasms NCT00300781
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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])
Prior treatment with herceptin
Item
prior treatment with herceptin (arm b only)
boolean
C1514463 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
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])
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])
C0006147 (UMLS CUI [2])
Swallowing problem
Item
inability to swallow the hki-272 capsules
boolean
C0392678 (UMLS CUI [1])