Information:
Fel:
ID
14218
Beskrivning
UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00146042
Länk
https://clinicaltrials.gov/show/NCT00146042
Nyckelord
Versioner (1)
- 2016-04-04 2016-04-04 -
Uppladdad den
4 april 2016
DOI
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Licens
Creative Commons BY 4.0
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Eligibility HER-2 Positive Metastatic Breast Cancer NCT00146042
Eligibility HER-2 Positive Metastatic Breast Cancer NCT00146042
- StudyEvent: Eligibility
Similar models
Eligibility HER-2 Positive Metastatic Breast Cancer NCT00146042
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Metastatic breast cancer
Item
patients with biopsy proven, measurable metastatic breast cancer. patients with bone-only, and/or effusion-only disease are excluded.
boolean
C0278488 (UMLS CUI [1])
Her-2 neu by immunohistochemical criteria
Item
her-2 neu positive by standard immunohistochemical criteria (2+ positivity).
boolean
C0069515 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,2])
Chemotherapy for distant metastatic disease
Item
no prior chemotherapy for distant metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
C0278488 (UMLS CUI [1,2])
Paclitaxel in adjuvant setting
Item
prior paclitaxel in the adjuvant setting is allowed.
boolean
C0144576 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C1522673 (UMLS CUI [1,2])
Karnofsky performance status
Item
karnofsky performance status equal to 70 or greater.
boolean
C0206065 (UMLS CUI [1])
Laboratory parameters
Item
anc > 1500, hgb > 10, plt > 100.
boolean
C0948762 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
C0518015 (UMLS CUI [2])
C0005821 (UMLS CUI [3])
Liver and kidney function
Item
patients with some degree of hepatic dysfunction and renal dysfunction are encouraged, in order to evaluate the ability of the ermbt in tailoring dose in these patient populations.
boolean
C0232741 (UMLS CUI [1])
C0232804 (UMLS CUI [2])
C0232804 (UMLS CUI [2])
Age
Item
age less than 18 years.
boolean
C0001779 (UMLS CUI [1])
Allergy to erythromycin
Item
allergy to erythromycin.
boolean
C0020517 (UMLS CUI [1,1])
C0014806 (UMLS CUI [1,2])
C0014806 (UMLS CUI [1,2])
Docetaxel and paclitaxel
Item
previous treatment with docetaxel. prior paclitaxel is allowed.
boolean
C0246415 (UMLS CUI [1])
C0144576 (UMLS CUI [2])
C0144576 (UMLS CUI [2])
Peripheral neuropathy grade
Item
grade > 2 peripheral neuropathy.
boolean
C3869673 (UMLS CUI [1])
Confounding factors
Item
no confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy).
boolean
C0009673 (UMLS CUI [1])
Gynaecologocial status
Item
patients who are pregnant or nursing will not be eligible for this protocol. women of childbearing age who are not practicing reliable birth control must have a documented negative serum hcg.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C1960468 (UMLS CUI [3,1])
C2348195 (UMLS CUI [3,2])
C0006147 (UMLS CUI [2])
C1960468 (UMLS CUI [3,1])
C2348195 (UMLS CUI [3,2])
Inducing or inhibiting cyp3a
Item
patients who require concurrent treatment with drugs which are known to induce or inhibit cyp3a activity will be ineligible for the trial. this list includes the drugs midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, anti-seizure drugs, and rifampin (induction).
boolean
C3850044 (UMLS CUI [1])
C3850056 (UMLS CUI [2])
C3850056 (UMLS CUI [2])