ID

33355

Description

Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01206881

Link

https://clinicaltrials.gov/show/NCT01206881

Keywords

  1. 12/6/18 12/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

December 6, 2018

DOI

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License

Creative Commons BY 4.0

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Eligibility Breast Cancer NCT01206881

Eligibility Breast Cancer NCT01206881

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
pathologically proven breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
inflammatory, locally advanced breast cancer or a tumor > 5 cm
Description

Locally advanced breast cancer inflammatory | Tumor Size

Data type

boolean

Alias
UMLS CUI [1,1]
C3495949
UMLS CUI [1,2]
C0333348
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C0456389
ecog performance status < 2
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
lvef > 50% measured by muga (her2 positive patients)
Description

Left ventricular ejection fraction MUGA | Patients HER2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C2348909
adequate bone marrow, liver and renal function
Description

Bone Marrow function | Liver function | Renal function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
written informed consent must be obtained
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
another malignancy within 5 years prior to study entry
Description

Cancer Other

Data type

boolean

Alias
UMLS CUI [1]
C1707251
concurrent treatment with an investigational agent
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
other disease or condition that contraindicates participation in the study
Description

Disease Study Subject Participation Status Contraindicated | Condition Study Subject Participation Status Contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444657
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1444657
pregnant or lactating females
Description

Pregnancy | Breast Feeding

Data type

boolean

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

Similar models

Eligibility Breast Cancer NCT01206881

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
pathologically proven breast cancer
boolean
C0678222 (UMLS CUI [1])
Locally advanced breast cancer inflammatory | Tumor Size
Item
inflammatory, locally advanced breast cancer or a tumor > 5 cm
boolean
C3495949 (UMLS CUI [1,1])
C0333348 (UMLS CUI [1,2])
C0027651 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status < 2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction MUGA | Patients HER2 Positive
Item
lvef > 50% measured by muga (her2 positive patients)
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Informed Consent
Item
written informed consent must be obtained
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other
Item
another malignancy within 5 years prior to study entry
boolean
C1707251 (UMLS CUI [1])
Investigational New Drugs
Item
concurrent treatment with an investigational agent
boolean
C0013230 (UMLS CUI [1])
Disease Study Subject Participation Status Contraindicated | Condition Study Subject Participation Status Contraindicated
Item
other disease or condition that contraindicates participation in the study
boolean
C0012634 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444657 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444657 (UMLS CUI [2,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating females
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])

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