ID

14218

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00146042

Trefwoorden

  1. 04-04-16 04-04-16 -
Geüploaded op

4 april 2016

DOI

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Licentie

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

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with biopsy proven, measurable metastatic breast cancer. patients with bone-only, and/or effusion-only disease are excluded.
Beschrijving

Metastatic breast cancer

Datatype

boolean

Alias
UMLS CUI [1]
C0278488
her-2 neu positive by standard immunohistochemical criteria (2+ positivity).
Beschrijving

Her-2 neu by immunohistochemical criteria

Datatype

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C0021044
no prior chemotherapy for distant metastatic disease.
Beschrijving

Chemotherapy for distant metastatic disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0278488
prior paclitaxel in the adjuvant setting is allowed.
Beschrijving

Paclitaxel in adjuvant setting

Datatype

boolean

Alias
UMLS CUI [1,1]
C0144576
UMLS CUI [1,2]
C1522673
karnofsky performance status equal to 70 or greater.
Beschrijving

Karnofsky performance status

Datatype

boolean

Alias
UMLS CUI [1]
C0206065
anc > 1500, hgb > 10, plt > 100.
Beschrijving

Laboratory parameters

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0005821
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.
Beschrijving

Liver and kidney function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0232804
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
age less than 18 years.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
allergy to erythromycin.
Beschrijving

Allergy to erythromycin

Datatype

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014806
previous treatment with docetaxel. prior paclitaxel is allowed.
Beschrijving

Docetaxel and paclitaxel

Datatype

boolean

Alias
UMLS CUI [1]
C0246415
UMLS CUI [2]
C0144576
grade > 2 peripheral neuropathy.
Beschrijving

Peripheral neuropathy grade

Datatype

boolean

Alias
UMLS CUI [1]
C3869673
no confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy).
Beschrijving

Confounding factors

Datatype

boolean

Alias
UMLS CUI [1]
C0009673
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.
Beschrijving

Gynaecologocial status

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C1960468
UMLS CUI [3,2]
C2348195
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).
Beschrijving

Inducing or inhibiting cyp3a

Datatype

boolean

Alias
UMLS CUI [1]
C3850044
UMLS CUI [2]
C3850056

Similar models

Eligibility HER-2 Positive Metastatic Breast Cancer NCT00146042

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
Chemotherapy for distant metastatic disease
Item
no prior chemotherapy for distant metastatic disease.
boolean
C0392920 (UMLS CUI [1,1])
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
Docetaxel and paclitaxel
Item
previous treatment with docetaxel. prior paclitaxel is allowed.
boolean
C0246415 (UMLS CUI [1])
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])
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])

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