ID

26088

Description

Neoadjuvant Carboplatin, Weekly Abraxane and Trastuzumab in HER2+ Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00617942

Lien

https://clinicaltrials.gov/show/NCT00617942

Mots-clés

  1. 09/10/2017 09/10/2017 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

9 octobre 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT00617942

Eligibility Breast Cancer NCT00617942

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented adenocarcinoma of the breast
Description

Breast adenocarcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0858252
anc > 1000 cells
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
female; age > 18; zubrod ps 0-1
Description

Gender | Age | Zubrod Performance Status

Type de données

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C3714786
platelets > 100,000
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
stage iia-iiib disease
Description

Disease TNM clinical staging

Type de données

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C3258246
total bilirubin < or = uln
Description

Serum total bilirubin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1278039
no evidence of metastatic disease not pregnant or lactating
Description

Exclusion Criteria | Neoplasm Metastasis | Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0027627
UMLS CUI [3]
C0032961
UMLS CUI [4]
C0006147
no prior systemic therapy for this breast cancer
Description

Exclusion Criteria | Systemic therapy Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1515119
UMLS CUI [2,2]
C0678222
serum creatinine < 1.5 mg/dl or creat cl > 30 ml/min
Description

Creatinine measurement, serum

Type de données

boolean

Alias
UMLS CUI [1]
C0201976
serum alt < 2.5 x uln
Description

serum alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C1883008
er, pr and her2 status required
Description

Estrogen Receptor Status Required | Progesterone Receptor Status Required | HER2/Neu Status Required

Type de données

boolean

Alias
UMLS CUI [1,1]
C1516974
UMLS CUI [1,2]
C1514873
UMLS CUI [2,1]
C1514471
UMLS CUI [2,2]
C1514873
UMLS CUI [3,1]
C1512413
UMLS CUI [3,2]
C1514873
lvef (muga/echo)wnl
Description

Left ventricular ejection fraction MUGA | Left ventricular ejection fraction Echocardiography

Type de données

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
no baseline > 2 neuropathy
Description

Neuropathy CTCAE Grades

Type de données

boolean

Alias
UMLS CUI [1,1]
C0442874
UMLS CUI [1,2]
C1516728
hemoglobin > 9.0 gm/dl
Description

Hemoglobin measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0518015
her2+, defined by ihc 3+ or fish ratio > 2.0
Description

HER2/Neu Positive | Immunohistochemistry Positive | HER2/CEP17 Ratio FISH

Type de données

boolean

Alias
UMLS CUI [1]
C2348909
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C1514241
UMLS CUI [3]
C1977461

Similar models

Eligibility Breast Cancer NCT00617942

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma
Item
histologically documented adenocarcinoma of the breast
boolean
C0858252 (UMLS CUI [1])
Absolute neutrophil count
Item
anc > 1000 cells
boolean
C0948762 (UMLS CUI [1])
Gender | Age | Zubrod Performance Status
Item
female; age > 18; zubrod ps 0-1
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C3714786 (UMLS CUI [3])
Platelet Count measurement
Item
platelets > 100,000
boolean
C0032181 (UMLS CUI [1])
Disease TNM clinical staging
Item
stage iia-iiib disease
boolean
C0012634 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
Serum total bilirubin measurement
Item
total bilirubin < or = uln
boolean
C1278039 (UMLS CUI [1])
Exclusion Criteria | Neoplasm Metastasis | Pregnancy | Breast Feeding
Item
no evidence of metastatic disease not pregnant or lactating
boolean
C0680251 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0032961 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
Exclusion Criteria | Systemic therapy Breast Carcinoma
Item
no prior systemic therapy for this breast cancer
boolean
C0680251 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
serum creatinine < 1.5 mg/dl or creat cl > 30 ml/min
boolean
C0201976 (UMLS CUI [1])
serum alanine aminotransferase measurement
Item
serum alt < 2.5 x uln
boolean
C1883008 (UMLS CUI [1])
Estrogen Receptor Status Required | Progesterone Receptor Status Required | HER2/Neu Status Required
Item
er, pr and her2 status required
boolean
C1516974 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1514471 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C1512413 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
Left ventricular ejection fraction MUGA | Left ventricular ejection fraction Echocardiography
Item
lvef (muga/echo)wnl
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Neuropathy CTCAE Grades
Item
no baseline > 2 neuropathy
boolean
C0442874 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin > 9.0 gm/dl
boolean
C0518015 (UMLS CUI [1])
HER2/Neu Positive | Immunohistochemistry Positive | HER2/CEP17 Ratio FISH
Item
her2+, defined by ihc 3+ or fish ratio > 2.0
boolean
C2348909 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C1977461 (UMLS CUI [3])

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