Informatie:
Fout:
ID
16010
Beschrijving
A Phase III Trial For Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00191152
Link
https://clinicaltrials.gov/show/NCT00191152
Trefwoorden
Versies (2)
- 02-05-16 02-05-16 -
- 26-06-16 26-06-16 -
Geüploaded op
26 juni 2016
DOI
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Licentie
Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00191152
Eligibility Breast Cancer NCT00191152
- StudyEvent: Eligibility
Similar models
Eligibility Breast Cancer NCT00191152
- StudyEvent: Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
confirmation of breast cancer, locally advanced or metastatic
Item
histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
boolean
C0019638 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0678222 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
prior taxane regimen
Item
patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it has been greater than or equal to 6 months since completion of the regimen
boolean
C3541958 (UMLS CUI [1])
Prior Chemotherapy
Item
patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
boolean
C1514457 (UMLS CUI [1])
measurable disease
Item
patients must have either measurable or non-measurable (evaluable) disease
boolean
C1513041 (UMLS CUI [1])
prior radiation therapy
Item
prior radiation therapy allowed of less than 25% of the bone marrow
boolean
C1522449 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,2])
second primary malignancy
Item
second primary malignancy (except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
boolean
C0751623 (UMLS CUI [1])
brain metastases
Item
parenchymal or leptomeningeal brain metastases
boolean
C0220650 (UMLS CUI [1])
peripheral neuropathy
Item
peripheral neuropathy greater than or equal to grade 2
boolean
C0031117 (UMLS CUI [1])
prior treatment with gemcitabine, capecitabine or taxane
Item
prior treatment with gemcitabine and capecitabine will not be allowed. prior treatment with a taxane in the metastatic setting will not be allowed. prior taxane therapy in the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than or equal to 6 months prior to enrollment.
boolean
C1514463 (UMLS CUI [1,1])
C0045093 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0045093 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C3541958 (UMLS CUI [3,2])
C0045093 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0045093 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C3541958 (UMLS CUI [3,2])
active cardiac disease
Item
active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,2])
concomitant herceptin therapy
Item
concomitant herceptin is not allowed
boolean
C1707479 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
C0338204 (UMLS CUI [1,2])