ID

30577

Description

Phase II Trial of Weekly or Every 3-week Ixabepilone for Patients With Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00593827

Link

https://clinicaltrials.gov/show/NCT00593827

Keywords

Versions (1)
  1. 6/16/18 6/16/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 16, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Metastatic Breast Cancer NCT00593827

English

Eligibility Metastatic Breast Cancer NCT00593827

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
has mbc that is measurable by recist or has nonmeasurable disease with serum ca27.29 (or ca15.3) ≥ 50
Description

Secondary malignant neoplasm of female breast Measurable | Non-Measurable Lesion Serum CA 27-29 Measurement | Non-Measurable Lesion Serum Mucin-1 Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C1334988
UMLS CUI [2,2]
C0229671
UMLS CUI [2,3]
C0291672
UMLS CUI [2,4]
C0242485
UMLS CUI [3,1]
C1334988
UMLS CUI [3,2]
C0229671
UMLS CUI [3,3]
C0006611
UMLS CUI [3,4]
C0242485
has human epidermal growth factor receptor 2 (her2) negative breast cancer
Description

Breast Carcinoma HER2 negative

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C4087376
prior chemotherapy is permitted with no limit on the number of prior regimens
Description

Prior Chemotherapy Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C1265611
two weeks or more have elapsed since last chemotherapy or radiation treatment
Description

Elapsed Time Since Chemotherapy | Elapsed Time Since Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C2826303
UMLS CUI [1,2]
C1711239
UMLS CUI [1,3]
C0392920
UMLS CUI [2,1]
C2826303
UMLS CUI [2,2]
C1711239
UMLS CUI [2,3]
C1522449
has an eastern cooperative oncology group (ecog) performance status (ps) of 0-2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
is female, ≥ 18 yrs of age
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
protocol defined appropriate laboratory values
Description

Laboratory Results Appropriate Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C2348563
negative pregnancy test within 7 calendar days prior to registration
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
has signed a patient informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
had prior treatment with ixabepilone or other epothilones
Description

Ixabepilone | Epothilones

Data type

boolean

Alias
UMLS CUI [1]
C1135132
UMLS CUI [2]
C1136012
has her2+ disease
Description

Disease HER2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
has a known, prior, severe (national cancer institute common terminology criteria adverse events [nci ctcae] grade 3-4) history of hypersensitivity reaction to a drug formulated in cremophor ® el (polyoxyethylated castor oil)
Description

Hypersensitivity CTCAE Grades Cremophor EL

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1516728
UMLS CUI [1,3]
C0056476
is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
Description

Immunotherapy | Hormone Therapy | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0021083
UMLS CUI [2]
C0279025
UMLS CUI [3]
C1522449
is receiving concurrent investigational therapy or has received such therapy within the past 30 days
Description

Therapy, investigational

Data type

boolean

Alias
UMLS CUI [1]
C0949266
has peripheral neuropathy > grade 1
Description

Peripheral Neuropathy CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
has evidence of central nervous system (cns) involvement requiring radiation or steroid treatment. participants with stable brain metastases who are off steroids at least 2 weeks are eligible
Description

Central Nervous System Involvement Requirement Therapeutic radiology procedure | Central Nervous System Involvement Requirement Steroids | Eligibility Metastatic malignant neoplasm to brain Stable | Relationship Steroids Free of

Data type

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C1522449
UMLS CUI [2,1]
C4050309
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0038317
UMLS CUI [3,1]
C1548635
UMLS CUI [3,2]
C0220650
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C0439849
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C0332296
is pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
Back to the top of the page

Similar models

Eligibility Metastatic Breast Cancer NCT00593827

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast Measurable | Non-Measurable Lesion Serum CA 27-29 Measurement | Non-Measurable Lesion Serum Mucin-1 Measurement
Item
has mbc that is measurable by recist or has nonmeasurable disease with serum ca27.29 (or ca15.3) ≥ 50
boolean
C0346993 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C1334988 (UMLS CUI [2,1])
C0229671 (UMLS CUI [2,2])
C0291672 (UMLS CUI [2,3])
C0242485 (UMLS CUI [2,4])
C1334988 (UMLS CUI [3,1])
C0229671 (UMLS CUI [3,2])
C0006611 (UMLS CUI [3,3])
C0242485 (UMLS CUI [3,4])
Breast Carcinoma HER2 negative
Item
has human epidermal growth factor receptor 2 (her2) negative breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C4087376 (UMLS CUI [1,2])
Prior Chemotherapy Quantity
Item
prior chemotherapy is permitted with no limit on the number of prior regimens
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Elapsed Time Since Chemotherapy | Elapsed Time Since Therapeutic radiology procedure
Item
two weeks or more have elapsed since last chemotherapy or radiation treatment
boolean
C2826303 (UMLS CUI [1,1])
C1711239 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C2826303 (UMLS CUI [2,1])
C1711239 (UMLS CUI [2,2])
C1522449 (UMLS CUI [2,3])
ECOG performance status
Item
has an eastern cooperative oncology group (ecog) performance status (ps) of 0-2
boolean
C1520224 (UMLS CUI [1])
Gender | Age
Item
is female, ≥ 18 yrs of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Laboratory Results Appropriate Study Protocol
Item
protocol defined appropriate laboratory values
boolean
C1254595 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Pregnancy test negative
Item
negative pregnancy test within 7 calendar days prior to registration
boolean
C0427780 (UMLS CUI [1])
Informed Consent
Item
has signed a patient informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Ixabepilone | Epothilones
Item
had prior treatment with ixabepilone or other epothilones
boolean
C1135132 (UMLS CUI [1])
C1136012 (UMLS CUI [2])
Disease HER2 Positive
Item
has her2+ disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Hypersensitivity CTCAE Grades Cremophor EL
Item
has a known, prior, severe (national cancer institute common terminology criteria adverse events [nci ctcae] grade 3-4) history of hypersensitivity reaction to a drug formulated in cremophor ® el (polyoxyethylated castor oil)
boolean
C0020517 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
C0056476 (UMLS CUI [1,3])
Immunotherapy | Hormone Therapy | Therapeutic radiology procedure
Item
is receiving concurrent immunotherapy, hormonal therapy or radiation therapy
boolean
C0021083 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
Therapy, investigational
Item
is receiving concurrent investigational therapy or has received such therapy within the past 30 days
boolean
C0949266 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
has peripheral neuropathy > grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Central Nervous System Involvement Requirement Therapeutic radiology procedure | Central Nervous System Involvement Requirement Steroids | Eligibility Metastatic malignant neoplasm to brain Stable | Relationship Steroids Free of
Item
has evidence of central nervous system (cns) involvement requiring radiation or steroid treatment. participants with stable brain metastases who are off steroids at least 2 weeks are eligible
boolean
C4050309 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1522449 (UMLS CUI [1,3])
C4050309 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0038317 (UMLS CUI [2,3])
C1548635 (UMLS CUI [3,1])
C0220650 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C0439849 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0332296 (UMLS CUI [4,3])
Pregnancy | Breast Feeding
Item
is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial