ID

30257

Description

Phase I Study of Ixabepilone Plus Lapatinib With or Without Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00634088

Link

https://clinicaltrials.gov/show/NCT00634088

Keywords

Versions (1)
  1. 5/25/18 5/25/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 25, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Locally Advanced or Metastatic Breast Cancer NCT00634088

English

Eligibility Locally Advanced or Metastatic Breast Cancer NCT00634088

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
Description

Gender | Age | Breast adenocarcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0858252
radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a t4 tumor and stage iiib/iiic disease) and not curable by local measures, such as radiation or surgery
Description

Neoplasm Metastasis TNM clinical staging | Locally Advanced Malignant Neoplasm TNM clinical staging | Incurable disease | Therapeutic radiology procedure Unsuccessful | Operative Surgical Procedures Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C3258246
UMLS CUI [2,1]
C0677984
UMLS CUI [2,2]
C3258246
UMLS CUI [3]
C0175969
UMLS CUI [4,1]
C1522449
UMLS CUI [4,2]
C1272705
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C1272705
positive status for human epidermal growth factor receptor 2
Description

HER2/Neu Positive

Data type

boolean

Alias
UMLS CUI [1]
C2348909
measurable disease as per response evaluation criteria in solid tumors guidelines
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
karnofsky performance status of 70 to 100
Description

Karnofsky Performance Status

Data type

boolean

Alias
UMLS CUI [1]
C0206065
life expectancy of at least 3 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
Description

Irradiation of pelvis Bone Marrow Percentage | Prior radiation therapy Lumbar spine Bone Marrow Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0747411
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0024091
UMLS CUI [2,3]
C0005953
UMLS CUI [2,4]
C0439165
common terminology criteria grade 2 or greater neuropathy
Description

Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
inadequate hematologic, hepatic, or renal function
Description

Hematologic function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
known prior severe hypersensitivity reactions to agents containing cremophor® el or known hypersensitivity or prior intolerance to fluoropyrimidine
Description

Severe allergy Cremophor EL Pharmaceutical Preparations | Hypersensitivity Fluoropyrimidine | Intolerance to Fluoropyrimidine

Data type

boolean

Alias
UMLS CUI [1,1]
C2945656
UMLS CUI [1,2]
C0056476
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0596581
UMLS CUI [3,1]
C1744706
UMLS CUI [3,2]
C0596581
known or suspected dihydropyrimidine dehydrogenase deficiency
Description

Dihydropyrimidine Dehydrogenase Deficiency | Dihydropyrimidine Dehydrogenase Deficiency Suspected

Data type

boolean

Alias
UMLS CUI [1]
C1959620
UMLS CUI [2,1]
C1959620
UMLS CUI [2,2]
C0750491
more than 3 prior chemotherapy regimens in the metastatic setting
Description

Chemotherapy Regimen Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
Description

Epothilone | lapatinib | capecitabine

Data type

boolean

Alias
UMLS CUI [1]
C1136012
UMLS CUI [2]
C1506770
UMLS CUI [3]
C0671970
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Similar models

Eligibility Locally Advanced or Metastatic Breast Cancer NCT00634088

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | Breast adenocarcinoma
Item
females aged 18 years or older with histologic or cytologic diagnosis of adenocarcinoma originating in the breast
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0858252 (UMLS CUI [3])
Neoplasm Metastasis TNM clinical staging | Locally Advanced Malignant Neoplasm TNM clinical staging | Incurable disease | Therapeutic radiology procedure Unsuccessful | Operative Surgical Procedures Unsuccessful
Item
radiologic or pathologic evidence that the cancer is metastatic or locally advanced (a t4 tumor and stage iiib/iiic disease) and not curable by local measures, such as radiation or surgery
boolean
C0027627 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0677984 (UMLS CUI [2,1])
C3258246 (UMLS CUI [2,2])
C0175969 (UMLS CUI [3])
C1522449 (UMLS CUI [4,1])
C1272705 (UMLS CUI [4,2])
C0543467 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
HER2/Neu Positive
Item
positive status for human epidermal growth factor receptor 2
boolean
C2348909 (UMLS CUI [1])
Measurable Disease
Item
measurable disease as per response evaluation criteria in solid tumors guidelines
boolean
C1513041 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky performance status of 70 to 100
boolean
C0206065 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of at least 3 months
boolean
C0023671 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Irradiation of pelvis Bone Marrow Percentage | Prior radiation therapy Lumbar spine Bone Marrow Percentage
Item
prior radiation must not have included 30% or more of major bone-marrow containing areas, such as the pelvis and lumbar spine
boolean
C0747411 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0279134 (UMLS CUI [2,1])
C0024091 (UMLS CUI [2,2])
C0005953 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
Neuropathy CTCAE Grades
Item
common terminology criteria grade 2 or greater neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hematologic function | Liver function | Renal function
Item
inadequate hematologic, hepatic, or renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Severe allergy Cremophor EL Pharmaceutical Preparations | Hypersensitivity Fluoropyrimidine | Intolerance to Fluoropyrimidine
Item
known prior severe hypersensitivity reactions to agents containing cremophor® el or known hypersensitivity or prior intolerance to fluoropyrimidine
boolean
C2945656 (UMLS CUI [1,1])
C0056476 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0596581 (UMLS CUI [2,2])
C1744706 (UMLS CUI [3,1])
C0596581 (UMLS CUI [3,2])
Dihydropyrimidine Dehydrogenase Deficiency | Dihydropyrimidine Dehydrogenase Deficiency Suspected
Item
known or suspected dihydropyrimidine dehydrogenase deficiency
boolean
C1959620 (UMLS CUI [1])
C1959620 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
Chemotherapy Regimen Quantity Neoplasm Metastasis
Item
more than 3 prior chemotherapy regimens in the metastatic setting
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Epothilone | lapatinib | capecitabine
Item
prior treatment with an epothilone or lapatinib; prior treatment with capecitabine within the past 6 months
boolean
C1136012 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
C0671970 (UMLS CUI [3])
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