ID

30577

Descripción

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

Palabras clave

Versiones (1)
  1. 16/6/18 16/6/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

16 de junio de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00593827

Inglés

Eligibility Metastatic Breast Cancer NCT00593827

1 formularios  
Inclusion Criteria
Descripción

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
Descripción

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

Tipo de datos

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
Descripción

Breast Carcinoma HER2 negative

Tipo de datos

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
Descripción

Prior Chemotherapy Quantity

Tipo de datos

boolean

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

Elapsed Time Since Chemotherapy | Elapsed Time Since Therapeutic radiology procedure

Tipo de datos

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
Descripción

ECOG performance status

Tipo de datos

boolean

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

Gender | Age

Tipo de datos

boolean

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

Laboratory Results Appropriate Study Protocol

Tipo de datos

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
Descripción

Pregnancy test negative

Tipo de datos

boolean

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

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

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

Ixabepilone | Epothilones

Tipo de datos

boolean

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

Disease HER2 Positive

Tipo de datos

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)
Descripción

Hypersensitivity CTCAE Grades Cremophor EL

Tipo de datos

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
Descripción

Immunotherapy | Hormone Therapy | Therapeutic radiology procedure

Tipo de datos

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
Descripción

Therapy, investigational

Tipo de datos

boolean

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

Peripheral Neuropathy CTCAE Grades

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Metastatic Breast Cancer NCT00593827

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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