ID

16420

Description

Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility; ODM derived from: https://clinicaltrials.gov/show/NCT00591851

Lien

https://clinicaltrials.gov/show/NCT00591851

Mots-clés

Versions (1)
  1. 15/07/2016 15/07/2016 -
Téléchargé le

15 juillet 2016

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00591851

Anglais

Eligibility Breast Cancer NCT00591851

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adenocarcinoma breast cancer
Description

Breast adenocarcinoma

Type de données

boolean

Alias
UMLS CUI [1]
C0858252
ecog performance status of 0 or 1
Description

ECOG performance status

Type de données

boolean

Alias
UMLS CUI [1]
C1520224
peripheral neuropathy less than or equal to 1
Description

Peripheral Neuropathy Grade

Type de données

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0441800
discontinued hormonal therapy as a chemoprevention while onstudy
Description

Hormone Therapy Discontinued | Chemoprevention

Type de données

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1444662
UMLS CUI [2]
C0282515
lvef by muga > 55%?
Description

Left ventricular ejection fraction | Multiple gated acquisition scanning

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0521317
absolute neutrophil count (anc)> 1000/µl)
Description

Absolute neutrophil count

Type de données

boolean

Alias
UMLS CUI [1]
C0948762
platelet count > 100,000/µl)
Description

Platelet Count measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0032181
sgot or sgpt < 92.5 units/l
Description

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
stage iv breast cancer
Description

Carcinoma breast stage IV

Type de données

boolean

Alias
UMLS CUI [1]
C0278488
any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a current breast cancer
Description

Chemotherapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma | Immunotherapy Breast Carcinoma | Biotherapy Breast Carcinoma

Type de données

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C0021083
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0005527
UMLS CUI [4,2]
C0678222
pregnant or lactating patients
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer
Description

Neoplasms, Second Primary | Skin carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate

Type de données

boolean

Alias
UMLS CUI [1]
C0085183
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1522326
UMLS CUI [2,3]
C0205411
UMLS CUI [3,1]
C0851140
UMLS CUI [3,2]
C1522326
UMLS CUI [3,3]
C0205411
previous allergy/hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, or other drugs formulated in cremophor el?
Description

Hypersensitivity Doxorubicin | Hypersensitivity Cyclophosphamide | Hypersensitivity Paclitaxel | Hypersensitivity cremophor EL

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013089
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0010583
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0144576
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0056476
unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months
Description

Angina, Unstable | Congestive heart failure | Digitalis Use of | Adrenergic beta-Antagonists | Calcium Blockers | Cardiac Arrhythmia Requirement Therapeutic procedure | Myocardial Infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0018802
UMLS CUI [3,1]
C0304520
UMLS CUI [3,2]
C1524063
UMLS CUI [4]
C0001645
UMLS CUI [5]
C0006684
UMLS CUI [6,1]
C0003811
UMLS CUI [6,2]
C1514873
UMLS CUI [6,3]
C0087111
UMLS CUI [7]
C0027051
psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements?
Description

Mental disorders Compliance behavior Limited

Type de données

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C0439801
active, unresolved infections
Description

Communicable Diseases Resolved

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1514893
sensitivity to e. coli derived proteins
Description

Hypersensitivity Escherichia coli Proteins

Type de données

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0014834
UMLS CUI [1,3]
C0033684
prior chemotherapy with an anthracycline
Description

Anthracycline Antibiotics

Type de données

boolean

Alias
UMLS CUI [1]
C0003234
prior herceptin therapy
Description

Herceptin

Type de données

boolean

Alias
UMLS CUI [1]
C0338204
Retour au début de la page

Similar models

Eligibility Breast Cancer NCT00591851

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma
Item
adenocarcinoma breast cancer
boolean
C0858252 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Peripheral Neuropathy Grade
Item
peripheral neuropathy less than or equal to 1
boolean
C0031117 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Hormone Therapy Discontinued | Chemoprevention
Item
discontinued hormonal therapy as a chemoprevention while onstudy
boolean
C0279025 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0282515 (UMLS CUI [2])
Left ventricular ejection fraction | Multiple gated acquisition scanning
Item
lvef by muga > 55%?
boolean
C0428772 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute neutrophil count (anc)> 1000/µl)
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count > 100,000/µl)
boolean
C0032181 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
sgot or sgpt < 92.5 units/l
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Carcinoma breast stage IV
Item
stage iv breast cancer
boolean
C0278488 (UMLS CUI [1])
Chemotherapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma | Immunotherapy Breast Carcinoma | Biotherapy Breast Carcinoma
Item
any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a current breast cancer
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0021083 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0005527 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
Pregnancy | Breast Feeding
Item
pregnant or lactating patients
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Neoplasms, Second Primary | Skin carcinoma Treated Adequate | Carcinoma in situ of uterine cervix Treated Adequate
Item
active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer
boolean
C0085183 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1522326 (UMLS CUI [2,2])
C0205411 (UMLS CUI [2,3])
C0851140 (UMLS CUI [3,1])
C1522326 (UMLS CUI [3,2])
C0205411 (UMLS CUI [3,3])
Hypersensitivity Doxorubicin | Hypersensitivity Cyclophosphamide | Hypersensitivity Paclitaxel | Hypersensitivity cremophor EL
Item
previous allergy/hypersensitivity to doxorubicin, cyclophosphamide, paclitaxel, or other drugs formulated in cremophor el?
boolean
C0020517 (UMLS CUI [1,1])
C0013089 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0010583 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0144576 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0056476 (UMLS CUI [4,2])
Angina, Unstable | Congestive heart failure | Digitalis Use of | Adrenergic beta-Antagonists | Calcium Blockers | Cardiac Arrhythmia Requirement Therapeutic procedure | Myocardial Infarction
Item
unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months
boolean
C0002965 (UMLS CUI [1])
C0018802 (UMLS CUI [2])
C0304520 (UMLS CUI [3,1])
C1524063 (UMLS CUI [3,2])
C0001645 (UMLS CUI [4])
C0006684 (UMLS CUI [5])
C0003811 (UMLS CUI [6,1])
C1514873 (UMLS CUI [6,2])
C0087111 (UMLS CUI [6,3])
C0027051 (UMLS CUI [7])
Mental disorders Compliance behavior Limited
Item
psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements?
boolean
C0004936 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Communicable Diseases Resolved
Item
active, unresolved infections
boolean
C0009450 (UMLS CUI [1,1])
C1514893 (UMLS CUI [1,2])
Hypersensitivity Escherichia coli Proteins
Item
sensitivity to e. coli derived proteins
boolean
C0020517 (UMLS CUI [1,1])
C0014834 (UMLS CUI [1,2])
C0033684 (UMLS CUI [1,3])
Anthracycline Antibiotics
Item
prior chemotherapy with an anthracycline
boolean
C0003234 (UMLS CUI [1])
Herceptin
Item
prior herceptin therapy
boolean
C0338204 (UMLS CUI [1])
Retour au début de la page 

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