Information:
Fel:
ID
16303
Beskrivning
PTK787 + Trastuzumab for HER2 Overexpressing Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00216047
Länk
https://clinicaltrials.gov/show/NCT00216047
Nyckelord
Versioner (1)
- 2016-07-10 2016-07-10 -
Uppladdad den
10 juli 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00216047
Eligibility Breast Cancer NCT00216047
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00216047
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease
Item
histologic or cytologic diagnosis of breast cancer with evidence of measurable (1) unresectable, locally recurrent, or (2) metastatic disease. locally recurrent disease must not be amenable to resection or radiation with curative intent.
boolean
C0678222 (UMLS CUI [1,1])
C1336869 (UMLS CUI [1,2])
C1458156 (UMLS CUI [1,3])
C0278488 (UMLS CUI [2])
C1336869 (UMLS CUI [1,2])
C1458156 (UMLS CUI [1,3])
C0278488 (UMLS CUI [2])
number of metastatic sites, pulmonary metastasis or liver metastasis involving 50 percent of parenchyma
Item
patient's disease may not involve more than 3 metastatic sites. in addition, patient may not be symptomatic from pulmonary metastasis or have liver metastasis involving > 50% of parenchyma.
boolean
C0280457 (UMLS CUI [1])
C0153676 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0153676 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
her2 gene amplification by fish
Item
her2 gene amplification by fish. her protein overexpression by immunohistochemistry will not be sufficient for entry.
boolean
C1512127 (UMLS CUI [1,1])
C0162789 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,2])
pregnancy test
Item
negative pregnancy test
boolean
C0032976 (UMLS CUI [1])
prior cytotoxic chemotherapy or trastuzumab
Item
no prior cytotoxic chemotherapy or trastuzumab for locally recurrent or metastatic disease.
boolean
C0677881 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C0728747 (UMLS CUI [2])
prior treatment with any vegf inhibiting agents
Item
no prior treatment with any vegf inhibiting agents
boolean
C0596087 (UMLS CUI [1])
central nervous system disease
Item
no history or presence of central nervous system (cns) disease.
boolean
C0007682 (UMLS CUI [1])
Cancer Therapy
Item
no other forms of cancer therapy including radiation, chemotherapy and hormonal therapy within 21 days prior to being registered for protocol therapy.
boolean
C0920425 (UMLS CUI [1])
Surgery
Item
no major surgery within 28 days prior to being registered for protocol therapy.
boolean
C0543467 (UMLS CUI [1])
Hypertension
Item
no uncontrolled hypertension (sbp > 170, dbp > 90), history of labile hypertension or history of poor compliance with antihypertensive therapy.
boolean
C0020538 (UMLS CUI [1,1])
C0005823 (UMLS CUI [1,2])
C0005823 (UMLS CUI [1,2])
Anticoagulation therapy
Item
no requirement for therapeutic anticoagulation, regular aspirin (> 325 mg/day) or nsaid use.
boolean
C0003281 (UMLS CUI [1])
breast feeding
Item
no current breast feeding.
boolean
C0006147 (UMLS CUI [1])
Impairment of gastrointestinal function
Item
no impairment of gastrointestinal (gi) function that may significantly alter the absorption of ptk787.
boolean
C0232459 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0021826 (UMLS CUI [1,3])
C0392760 (UMLS CUI [1,2])
C0021826 (UMLS CUI [1,3])
Other serious concomitant systemic disorders
Item
no evidence of other serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])