ID

21846

Description

Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00334802

Link

https://clinicaltrials.gov/show/NCT00334802

Keywords

  1. 5/3/17 5/3/17 -
Uploaded on

May 3, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Metastatic Breast Cancer NCT00334802

Eligibility Metastatic Breast Cancer NCT00334802

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically and/or cytologically confirmed breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
Description

Adjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Chemotherapy Breast Carcinoma | Anthracycline

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C0392920
UMLS CUI [2,3]
C0678222
UMLS CUI [3]
C0003234
to have at least one measurable region
Description

Region Measurable Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0205147
UMLS CUI [1,2]
C1513040
UMLS CUI [1,3]
C1265611
eastern cooperative oncology group (ecog) performance status: 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
to have adequate organ function (bone marrow, liver and renal function)
Description

Organ function | Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0232741
UMLS CUI [4]
C0232804
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
to have interstitial pneumonia or pulmonary fibrosis
Description

Pneumonia, Interstitial | Pulmonary Fibrosis

Data type

boolean

Alias
UMLS CUI [1]
C0206061
UMLS CUI [2]
C0034069
to have inflammatory breast cancer
Description

Inflammatory Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0278601
within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
Description

Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3]
C0279025
UMLS CUI [4]
C0021083
UMLS CUI [5]
C0543467
to have brain metastases with symptoms
Description

Metastatic malignant neoplasm to brain Symptoms

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C1457887
to have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
Description

Severe medical complication | Myocardial Infarction | Communicable Disease | Drug Allergy | Diabetes Mellitus

Data type

boolean

Alias
UMLS CUI [1]
C3495031
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0009450
UMLS CUI [4]
C0013182
UMLS CUI [5]
C0011849

Similar models

Eligibility Metastatic Breast Cancer NCT00334802

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
histologically and/or cytologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Adjuvant Chemotherapy Breast Carcinoma | Neoadjuvant Chemotherapy Breast Carcinoma | Anthracycline
Item
received adjuvant/neo-adjuvant chemotherapy for breast cancer with anthracycline regimen
boolean
C0085533 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0600558 (UMLS CUI [2,1])
C0392920 (UMLS CUI [2,2])
C0678222 (UMLS CUI [2,3])
C0003234 (UMLS CUI [3])
Region Measurable Quantity
Item
to have at least one measurable region
boolean
C0205147 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status: 0-1
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function | Liver function | Renal function
Item
to have adequate organ function (bone marrow, liver and renal function)
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0232741 (UMLS CUI [3])
C0232804 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Pneumonia, Interstitial | Pulmonary Fibrosis
Item
to have interstitial pneumonia or pulmonary fibrosis
boolean
C0206061 (UMLS CUI [1])
C0034069 (UMLS CUI [2])
Inflammatory Breast Carcinoma
Item
to have inflammatory breast cancer
boolean
C0278601 (UMLS CUI [1])
Chemotherapy | Therapeutic radiology procedure | Hormone Therapy | Immunotherapy | Operative Surgical Procedures
Item
within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0279025 (UMLS CUI [3])
C0021083 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
Metastatic malignant neoplasm to brain Symptoms
Item
to have brain metastases with symptoms
boolean
C0220650 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
Severe medical complication | Myocardial Infarction | Communicable Disease | Drug Allergy | Diabetes Mellitus
Item
to have severe complication (cardiac infarction, infection, drug hypersensitivity or diabetes)
boolean
C3495031 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0009450 (UMLS CUI [3])
C0013182 (UMLS CUI [4])
C0011849 (UMLS CUI [5])

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