ID

16259

Description

Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00193076

Link

https://clinicaltrials.gov/show/NCT00193076

Keywords

Versions (1)
  1. 7/8/16 7/8/16 -
Uploaded on

July 8, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00193076

English

Eligibility Breast Cancer NCT00193076

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
to be included in this study, you must meet the following criteria:
Description

ID.1

Data type

boolean

locally advanced or metastatic breast cancer
Description

Locally advanced breast cancer | Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0278488
measurable disease as per recist criteria
Description

Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1513041
no prior chemotherapy in the metastatic breast setting
Description

Prior Chemotherapy Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0278488
prior chemotherapy and/or hormonal therapy for early stage breast cancer
Description

Prior Chemotherapy Early-Stage Breast Carcinoma | Hormone Therapy Early-Stage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C2986665
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C2986665
adjuvant herceptin is allowed
Description

Herceptin Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0338204
UMLS CUI [1,2]
C1522673
prior radiation therapy in either the metastatic or early stage setting
Description

prior radiation therapy Carcinoma breast stage IV | prior radiation therapy Early-Stage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0278488
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C2986665
patients may have received any number of hormonal therapies
Description

Hormone Therapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1265611
age >18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
only women are eligible for the study
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
able to perform activities of daily living with minimal assistance
Description

Performance of activities of daily living Ability | Assistance Minimal

Data type

boolean

Alias
UMLS CUI [1,1]
C1821398
UMLS CUI [1,2]
C0085732
UMLS CUI [2,1]
C0557034
UMLS CUI [2,2]
C0547040
normal organ and bone marrow function
Description

organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
patients who will be receiving trastuzumab must have normal heart function
Description

trastuzumab | Cardiac function

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2]
C0232164
sign a written informed consent document
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
you cannot participate in this study if any of the following apply to you:
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
received prior chemotherapy for metastatic breast cancer
Description

Prior Chemotherapy Carcinoma breast stage IV

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0278488
known leptomeningeal carcinomatosis
Description

Leptomeningeal Carcinomatosis

Data type

boolean

Alias
UMLS CUI [1]
C0220654
uncontrolled brain metastasis
Description

Metastatic malignant neoplasm to brain Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0205318
uncontrolled intercurrent illness
Description

Intercurrent disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0277557
UMLS CUI [1,2]
C0205318
pregnant or lactating
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
history of other non-breast cancer malignancy
Description

Malignant Neoplasms | Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0678222
received prior chemotherapy for early stage breast cancer within 6 months
Description

Prior Chemotherapy Early-Stage Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C2986665
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Description

criteria Additional | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [2]
C2348568
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Similar models

Eligibility Breast Cancer NCT00193076

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
to be included in this study, you must meet the following criteria:
boolean
Locally advanced breast cancer | Carcinoma breast stage IV
Item
locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1])
C0278488 (UMLS CUI [2])
Measurable Disease
Item
measurable disease as per recist criteria
boolean
C1513041 (UMLS CUI [1])
Prior Chemotherapy Carcinoma breast stage IV
Item
no prior chemotherapy in the metastatic breast setting
boolean
C1514457 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
Prior Chemotherapy Early-Stage Breast Carcinoma | Hormone Therapy Early-Stage Breast Carcinoma
Item
prior chemotherapy and/or hormonal therapy for early stage breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C2986665 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C2986665 (UMLS CUI [2,2])
Herceptin Adjuvant
Item
adjuvant herceptin is allowed
boolean
C0338204 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
prior radiation therapy Carcinoma breast stage IV | prior radiation therapy Early-Stage Breast Carcinoma
Item
prior radiation therapy in either the metastatic or early stage setting
boolean
C0279134 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C2986665 (UMLS CUI [2,2])
Hormone Therapy Quantity
Item
patients may have received any number of hormonal therapies
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Age
Item
age >18 years
boolean
C0001779 (UMLS CUI [1])
Gender
Item
only women are eligible for the study
boolean
C0079399 (UMLS CUI [1])
Performance of activities of daily living Ability | Assistance Minimal
Item
able to perform activities of daily living with minimal assistance
boolean
C1821398 (UMLS CUI [1,1])
C0085732 (UMLS CUI [1,2])
C0557034 (UMLS CUI [2,1])
C0547040 (UMLS CUI [2,2])
organ function | Bone Marrow function
Item
normal organ and bone marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
trastuzumab | Cardiac function
Item
patients who will be receiving trastuzumab must have normal heart function
boolean
C0728747 (UMLS CUI [1])
C0232164 (UMLS CUI [2])
Informed consent
Item
sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status
Item
you cannot participate in this study if any of the following apply to you:
boolean
C2348568 (UMLS CUI [1])
Prior Chemotherapy Carcinoma breast stage IV
Item
received prior chemotherapy for metastatic breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
Leptomeningeal Carcinomatosis
Item
known leptomeningeal carcinomatosis
boolean
C0220654 (UMLS CUI [1])
Metastatic malignant neoplasm to brain Uncontrolled
Item
uncontrolled brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Intercurrent disease Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0277557 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms | Breast Carcinoma
Item
history of other non-breast cancer malignancy
boolean
C0006826 (UMLS CUI [1])
C0678222 (UMLS CUI [2])
Prior Chemotherapy Early-Stage Breast Carcinoma
Item
received prior chemotherapy for early stage breast cancer within 6 months
boolean
C1514457 (UMLS CUI [1,1])
C2986665 (UMLS CUI [1,2])
criteria Additional | Study Subject Participation Status
Item
please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
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