Informações:
Falhas:
ID
16164
Descrição
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
Palavras-chave
Versões (1)
- 03/07/2016 03/07/2016 -
Transferido a
3 de julho de 2016
DOI
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Licença
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
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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])