ID

26055

Beschreibung

Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00455533

Link

https://clinicaltrials.gov/show/NCT00455533

Stichworte

Versionen (1)
  1. 05.10.17 05.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

5. Oktober 2017

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00455533

Englisch

Eligibility Breast Cancer NCT00455533

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed primary invasive adenocarcinoma of the breast , t2-3, n0-3, m0, with tumor size of ≥ 2 cm
Beschreibung

Breast adenocarcinoma Invasive Primary TNM clinical staging | Tumor size

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0205225
UMLS CUI [1,4]
C3258246
UMLS CUI [2]
C0475440
all patients with early stage breast adenocarcinoma may enroll irrespective of receptor status
Beschreibung

Breast adenocarcinoma Early stage | Enrollment Independent of Receptor status

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C2363430
UMLS CUI [2,1]
C1516879
UMLS CUI [2,2]
C0332291
UMLS CUI [2,3]
C0449443
no prior treatment for breast cancer excluding therapy for dcis
Beschreibung

Breast Carcinoma untreated | Exception Therapeutic procedure Noninfiltrating Intraductal Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C0007124
karnofsky performance status of 80 - 100
Beschreibung

Karnofsky Performance Status

Datentyp

boolean

Alias
UMLS CUI [1]
C0206065
left ventricular ejection fraction (lvef) ≥ 50% by echocardiogram or multiple gated acquisition (muga)
Beschreibung

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
adequate hematologic, hepatic and renal function
Beschreibung

Hematologic function | Liver function | Renal function

Datentyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
women of child-bearing potential (wocbp) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
Beschreibung

Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C1299582
UMLS CUI [3]
C0013230
women who are pregnant or breastfeeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
inflammatory or metastatic breast cancer
Beschreibung

Inflammatory Breast Carcinoma | Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0278601
UMLS CUI [2]
C0346993
unfit for breast and/or axillary surgery
Beschreibung

Patient unfit for Operation on breast | Patient unfit for Operative Surgical Procedure Axillary

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3839996
UMLS CUI [1,2]
C3714726
UMLS CUI [2,1]
C3839996
UMLS CUI [2,2]
C0543467
UMLS CUI [2,3]
C0004454
evidence of baseline sensory or motor neuropathy
Beschreibung

Sensory neuropathy | Motor neuropathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0151313
UMLS CUI [2]
C0235025
significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (hiv) infection
Beschreibung

Cardiovascular Disease | Comorbidity Serious | Communicable Disease Serious | HIV Infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0205404
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C0205404
UMLS CUI [4]
C0019693
history of prior anthracycline therapy allergies to any study medication or cremophor® el
Beschreibung

Anthracyclines | Hypersensitivity Investigational New Drugs | Hypersensitivity Cremophor EL

Datentyp

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0056476
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Ähnliche Modelle

Eligibility Breast Cancer NCT00455533

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma Invasive Primary TNM clinical staging | Tumor size
Item
histologically confirmed primary invasive adenocarcinoma of the breast , t2-3, n0-3, m0, with tumor size of ≥ 2 cm
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C3258246 (UMLS CUI [1,4])
C0475440 (UMLS CUI [2])
Breast adenocarcinoma Early stage | Enrollment Independent of Receptor status
Item
all patients with early stage breast adenocarcinoma may enroll irrespective of receptor status
boolean
C0858252 (UMLS CUI [1,1])
C2363430 (UMLS CUI [1,2])
C1516879 (UMLS CUI [2,1])
C0332291 (UMLS CUI [2,2])
C0449443 (UMLS CUI [2,3])
Breast Carcinoma untreated | Exception Therapeutic procedure Noninfiltrating Intraductal Carcinoma
Item
no prior treatment for breast cancer excluding therapy for dcis
boolean
C0678222 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0007124 (UMLS CUI [2,3])
Karnofsky Performance Status
Item
karnofsky performance status of 80 - 100
boolean
C0206065 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA
Item
left ventricular ejection fraction (lvef) ≥ 50% by echocardiogram or multiple gated acquisition (muga)
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Hematologic function | Liver function | Renal function
Item
adequate hematologic, hepatic and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Childbearing Potential Contraceptive methods Unwilling | Childbearing Potential Contraceptive methods Unable | Investigational New Drugs
Item
women of child-bearing potential (wocbp) unwilling or unable to use an acceptable method to avoid pregnancy during and up to 8 weeks after the last dose of the investigational drug
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0013230 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
women who are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Inflammatory Breast Carcinoma | Secondary malignant neoplasm of female breast
Item
inflammatory or metastatic breast cancer
boolean
C0278601 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
Patient unfit for Operation on breast | Patient unfit for Operative Surgical Procedure Axillary
Item
unfit for breast and/or axillary surgery
boolean
C3839996 (UMLS CUI [1,1])
C3714726 (UMLS CUI [1,2])
C3839996 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0004454 (UMLS CUI [2,3])
Sensory neuropathy | Motor neuropathy
Item
evidence of baseline sensory or motor neuropathy
boolean
C0151313 (UMLS CUI [1])
C0235025 (UMLS CUI [2])
Cardiovascular Disease | Comorbidity Serious | Communicable Disease Serious | HIV Infection
Item
significant history of cardiovascular disease, serious intercurrent illness or infections including known human immu immunodeficiency virus (hiv) infection
boolean
C0007222 (UMLS CUI [1])
C0009488 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
C0019693 (UMLS CUI [4])
Anthracyclines | Hypersensitivity Investigational New Drugs | Hypersensitivity Cremophor EL
Item
history of prior anthracycline therapy allergies to any study medication or cremophor® el
boolean
C0282564 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0056476 (UMLS CUI [3,2])
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