ID

30576

Beschreibung

A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00490646

Link

https://clinicaltrials.gov/show/NCT00490646

Stichworte

Versionen (1)
  1. 16.06.18 16.06.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Juni 2018

DOI

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Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00490646

Englisch

Eligibility Metastatic Breast Cancer NCT00490646

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
locally advanced or metastatic her2+ breast cancer not previously treated with chemotherapy or trastuzumab.
Beschreibung

Locally advanced breast cancer | Secondary malignant neoplasm of female breast HER2 Positive | Chemotherapy Absent | Trastuzumab Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C2348909
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C0332197
subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
Beschreibung

Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Trastuzumab Adjuvant | Trastuzumab Neoadjuvant | Exception Recurrent disease Post Taxane | Exception Recurrent disease Post Trastuzumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0085533
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C1522673
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C0600558
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0277556
UMLS CUI [5,3]
C0687676
UMLS CUI [5,4]
C0215136
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0277556
UMLS CUI [6,3]
C0687676
UMLS CUI [6,4]
C0728747
measurable disease
Beschreibung

Measurable Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C1513041
left ventricular ejection fraction (lvef) ≥50%
Beschreibung

Left ventricular ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior chemotherapy or trastuzumab for metastatic breast cancer (mbc)
Beschreibung

Chemotherapy Secondary malignant neoplasm of female breast | Trastuzumab Secondary malignant neoplasm of female breast

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0346993
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0346993
relapse within 1 year after (neo)adjuvant taxane or trastuzumab
Beschreibung

Recurrent disease | Status post Taxane Adjuvant | Status post Taxane Neoadjuvant | Status post Trastuzumab Adjuvant | Status post Trastuzumab Neoadjuvant

Datentyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0215136
UMLS CUI [2,3]
C1522673
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0215136
UMLS CUI [3,3]
C0600558
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0728747
UMLS CUI [4,3]
C1522673
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0728747
UMLS CUI [5,3]
C0600558
neuropathy > grade 1
Beschreibung

Neuropathy CTCAE Grades

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
significant cardiovascular disease
Beschreibung

Cardiovascular Diseases

Datentyp

boolean

Alias
UMLS CUI [1]
C0007222
any brain metastases
Beschreibung

Metastatic malignant neoplasm to brain

Datentyp

boolean

Alias
UMLS CUI [1]
C0220650
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Ähnliche Modelle

Eligibility Metastatic Breast Cancer NCT00490646

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer | Secondary malignant neoplasm of female breast HER2 Positive | Chemotherapy Absent | Trastuzumab Absent
Item
locally advanced or metastatic her2+ breast cancer not previously treated with chemotherapy or trastuzumab.
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Chemotherapy, Adjuvant | Chemotherapy Neoadjuvant | Trastuzumab Adjuvant | Trastuzumab Neoadjuvant | Exception Recurrent disease Post Taxane | Exception Recurrent disease Post Trastuzumab
Item
subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were eligible except if they relapsed within 12 months after the last dose of a taxane or trastuzumab given as (neo)adjuvant therapy.
boolean
C0085533 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0277556 (UMLS CUI [5,2])
C0687676 (UMLS CUI [5,3])
C0215136 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0277556 (UMLS CUI [6,2])
C0687676 (UMLS CUI [6,3])
C0728747 (UMLS CUI [6,4])
Measurable Disease
Item
measurable disease
boolean
C1513041 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) ≥50%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Secondary malignant neoplasm of female breast | Trastuzumab Secondary malignant neoplasm of female breast
Item
prior chemotherapy or trastuzumab for metastatic breast cancer (mbc)
boolean
C0392920 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Recurrent disease | Status post Taxane Adjuvant | Status post Taxane Neoadjuvant | Status post Trastuzumab Adjuvant | Status post Trastuzumab Neoadjuvant
Item
relapse within 1 year after (neo)adjuvant taxane or trastuzumab
boolean
C0277556 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0215136 (UMLS CUI [2,2])
C1522673 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0215136 (UMLS CUI [3,2])
C0600558 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C1522673 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0728747 (UMLS CUI [5,2])
C0600558 (UMLS CUI [5,3])
Neuropathy CTCAE Grades
Item
neuropathy > grade 1
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cardiovascular Diseases
Item
significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Metastatic malignant neoplasm to brain
Item
any brain metastases
boolean
C0220650 (UMLS CUI [1])
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