Information:
Error:
ID
16164
Description
A Phase 1/2 Study Of HKI-272 (Neratinib) in Combination With Trastuzumab (Herceptin) In Subjects With Advanced Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00398567
Link
https://clinicaltrials.gov/show/NCT00398567
Keywords
Versions (1)
- 7/3/16 7/3/16 -
Uploaded on
July 3, 2016
DOI
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License
Creative Commons BY 4.0
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Eligibility Advanced Breast Cancer NCT00398567
Eligibility Advanced Breast Cancer NCT00398567
- StudyEvent: Eligibility
Similar models
Eligibility Advanced Breast Cancer NCT00398567
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
breast cancer
Item
pathologic diagnosis of breast cancer with current stage iiib, iiic or iv not curable by available therapy
boolean
C0678222 (UMLS CUI [1])
herceptin-containing cytotoxic chemotherapy
Item
progression following at least one herceptin-containing cytotoxic chemotherapy regimen (neoadjuvant, adjuvant, or metastatic setting)
boolean
C0338204 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,2])
her2 positive breast cancer
Item
her2 positive breast cancer
boolean
C3251092 (UMLS CUI [1])
at least one measurable target lesion
Item
at least one measurable target lesion
boolean
C2986546 (UMLS CUI [1])
performance status
Item
adequate performance status
boolean
C1520224 (UMLS CUI [1])
cardiac, kidney, and liver function
Item
adequate cardiac, kidney, and liver function
boolean
C0232741 (UMLS CUI [1])
blood count
Item
adequate blood counts
boolean
C0005771 (UMLS CUI [1])
birth control
Item
willingness of all subjects who are not surgically sterile or post menopausal to use acceptable methods of birth control
boolean
C0700589 (UMLS CUI [1])
cytotoxic chemotherapy regimen
Item
more than 3 prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,2])
major surgery
Item
major surgery, chemotherapy, radiotherapy, investigational agents, herceptin or other cancer therapy within 2 weeks of treatment day 1
boolean
C0679637 (UMLS CUI [1])
C0338204 (UMLS CUI [2])
C0338204 (UMLS CUI [2])
anthracyclines
Item
prior treatment with anthracyclines with cumulative dose of >400 mg/m^2
boolean
C3653626 (UMLS CUI [1])
visceral disease
Item
extensive visceral disease
boolean
C0234245 (UMLS CUI [1])
central nervous system metastases
Item
active central nervous system metastases
boolean
C0686377 (UMLS CUI [1])
pregnant or breast feeding women
Item
pregnant or breast feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0006147 (UMLS CUI [2])
gastrointestinal disorder
Item
significant chronic or recent acute gastrointestinal disorder with diarrhea as a major symptom
boolean
C0017178 (UMLS CUI [1])
prior exposure to hki-272 or other her2 targeted agents
Item
prior exposure to hki-272 or other her2 targeted agents (except herceptin and tykerb)
boolean
C1454298 (UMLS CUI [1])
cardiac disease
Item
significant cardiac disease or dysfunction
boolean
C0018799 (UMLS CUI [1])
hypersensitivity to herceptin
Item
history of life-threatening hypersensitivity to herceptin
boolean
C0020517 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
C0338204 (UMLS CUI [1,2])
swallow hki-272 capsules
Item
inability or unwillingness to swallow hki-272 capsules
boolean
C0566355 (UMLS CUI [1])
cancer
Item
any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin
boolean
C1274082 (UMLS CUI [1,1])
C2598420 (UMLS CUI [1,2])
C2598420 (UMLS CUI [1,2])