ID

16010

Beschreibung

A Phase III Trial For Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00191152

Link

https://clinicaltrials.gov/show/NCT00191152

Stichworte

  1. 02.05.16 02.05.16 -
  2. 26.06.16 26.06.16 -
Hochgeladen am

26. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00191152

Eligibility Breast Cancer NCT00191152

Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologic or cytologic confirmation of breast cancer with locally advanced and/or metastatic disease
Beschreibung

confirmation of breast cancer, locally advanced or metastatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019638
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0027627
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
Beschreibung

prior taxane regimen

Datentyp

boolean

Alias
UMLS CUI [1]
C3541958
patients may have had 0-1, but no more than one prior course of chemotherapy for metastatic disease
Beschreibung

Prior Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1514457
patients must have either measurable or non-measurable (evaluable) disease
Beschreibung

measurable disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
prior radiation therapy allowed of less than 25% of the bone marrow
Beschreibung

prior radiation therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0332152
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
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)
Beschreibung

second primary malignancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0751623
parenchymal or leptomeningeal brain metastases
Beschreibung

brain metastases

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
peripheral neuropathy greater than or equal to grade 2
Beschreibung

peripheral neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0031117
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.
Beschreibung

prior treatment with gemcitabine, capecitabine or taxane

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0045093
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C0045093
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C3541958
active cardiac disease not controlled by therapy and/or myocardial infarction within the preceding 6 months.
Beschreibung

active cardiac disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
concomitant herceptin is not allowed
Beschreibung

concomitant herceptin therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1707479
UMLS CUI [1,2]
C0338204

Ähnliche Modelle

Eligibility Breast Cancer NCT00191152

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
concomitant herceptin therapy
Item
concomitant herceptin is not allowed
boolean
C1707479 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])

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