ID

38235

Description

LUX-Breast 1: BIBW 2992 (Afatinib) in HER2-positive Metastatic Breast Cancer Patients After One Prior Herceptin Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01125566

Link

https://clinicaltrials.gov/show/NCT01125566

Keywords

Versions (1)
  1. 9/30/19 9/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01125566

English

Eligibility Breast Neoplasms NCT01125566

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed diagnosis of her2-overexpression breast cancer
Description

Breast Carcinoma HER2 Protein Overexpression

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1515560
stage iv metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
must have progressed on one prior trastuzumab treatment
Description

Prior Therapy | trastuzumab | Disease Progression

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0242656
no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
Description

trastuzumab | Prior Therapy Adjuvant | First line treatment Previous

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1522673
UMLS CUI [3,1]
C1708063
UMLS CUI [3,2]
C0205156
must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
Description

Adjuvant Chemotherapy Breast Carcinoma | Anthracyclines | taxane | First line treatment Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0282564
UMLS CUI [3]
C0215136
UMLS CUI [4,1]
C1708063
UMLS CUI [4,2]
C0346993
must have (archived) tumour tissue sample available for central re-assessment of her2-status
Description

Availability of Tumor tissue sample | Assessment Repeated HER2 Status

Data type

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C1516048
UMLS CUI [2,2]
C0205341
UMLS CUI [2,3]
C1512413
at least one measurable lesion according to recist 1.1.
Description

Measurable lesion Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1265611
ecog score of 0 or 1 .
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prior treatment with egfr/her2-targeted small molecules or antibodies other than trastuzumab
Description

Prior Therapy | Small Molecules HER2 Targeted | Antibodies HER2 Targeted | Exception Trastuzumab

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2,1]
C1328819
UMLS CUI [2,2]
C0069515
UMLS CUI [2,3]
C1521840
UMLS CUI [3,1]
C0003241
UMLS CUI [3,2]
C0069515
UMLS CUI [3,3]
C1521840
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0728747
prior treatment with vinorelbine
Description

Prior Therapy | vinorelbine

Data type

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0078257
known pre-existing interstitial lung disease
Description

Interstitial Lung Disease Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0206062
UMLS CUI [1,2]
C2347662
active brain metastases
Description

Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1]
C0220650
history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure nyha classification of 3, unstable angina or poorly controlled arrhythmia. myocardial infarction within 6 months prior to randomisation.
Description

Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0243050
UMLS CUI [2]
C1868885
UMLS CUI [3,1]
C0018802
UMLS CUI [3,2]
C1275491
UMLS CUI [4]
C0002965
UMLS CUI [5,1]
C0003811
UMLS CUI [5,2]
C3853134
UMLS CUI [6]
C0027051
cardiac left ventricular function with resting ejection fraction of less than 50%.
Description

Left Ventricular Function | EJECTION FRACTION RESTING

Data type

boolean

Alias
UMLS CUI [1]
C0080310
UMLS CUI [2]
C0743403
patients unable to comply with the protocol.
Description

Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
any contraindications for therapy with vinorelbine or trastuzumab.
Description

Medical contraindication Vinorelbine | Medical contraindication Trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0078257
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0728747
known hypersensitivity to bibw 2992 or the excipients of any of the trial drugs.
Description

Hypersensitivity BIBW 2992 | Hypersensitivity Investigational New Drug Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C4083270
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C0015237
use of any investigational drug within 4 weeks of randomisation.
Description

Use of Investigational New Drugs Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0013230
UMLS CUI [1,3]
C0332185
inadequate hepatic, renal and haematologic organ function
Description

Liver function Inadequate | Renal function Inadequate | Hematologic function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0232741
UMLS CUI [1,2]
C0205412
UMLS CUI [2,1]
C0232804
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0221130
UMLS CUI [3,2]
C0205412
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Similar models

Eligibility Breast Neoplasms NCT01125566

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma HER2 Protein Overexpression
Item
histologically confirmed diagnosis of her2-overexpression breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
stage iv metastatic disease
boolean
C0027627 (UMLS CUI [1])
Prior Therapy | trastuzumab | Disease Progression
Item
must have progressed on one prior trastuzumab treatment
boolean
C1514463 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
trastuzumab | Prior Therapy Adjuvant | First line treatment Previous
Item
no more than one prior trastuzumab based therapy regimen (either adjuvant or first-line)
boolean
C0728747 (UMLS CUI [1])
C1514463 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C1708063 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
Adjuvant Chemotherapy Breast Carcinoma | Anthracyclines | taxane | First line treatment Secondary malignant neoplasm of female breast
Item
must have received anthracycline and/or taxane based chemotherapy for adjuvant treatment of breast cancer or first-line treatment of metastatic breast cancer
boolean
C0085533 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0282564 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
C1708063 (UMLS CUI [4,1])
C0346993 (UMLS CUI [4,2])
Availability of Tumor tissue sample | Assessment Repeated HER2 Status
Item
must have (archived) tumour tissue sample available for central re-assessment of her2-status
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C1516048 (UMLS CUI [2,1])
C0205341 (UMLS CUI [2,2])
C1512413 (UMLS CUI [2,3])
Measurable lesion Quantity
Item
at least one measurable lesion according to recist 1.1.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
ECOG performance status
Item
ecog score of 0 or 1 .
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior Therapy | Small Molecules HER2 Targeted | Antibodies HER2 Targeted | Exception Trastuzumab
Item
prior treatment with egfr/her2-targeted small molecules or antibodies other than trastuzumab
boolean
C1514463 (UMLS CUI [1])
C1328819 (UMLS CUI [2,1])
C0069515 (UMLS CUI [2,2])
C1521840 (UMLS CUI [2,3])
C0003241 (UMLS CUI [3,1])
C0069515 (UMLS CUI [3,2])
C1521840 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
Prior Therapy | vinorelbine
Item
prior treatment with vinorelbine
boolean
C1514463 (UMLS CUI [1])
C0078257 (UMLS CUI [2])
Interstitial Lung Disease Pre-existing
Item
known pre-existing interstitial lung disease
boolean
C0206062 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain
Item
active brain metastases
boolean
C0220650 (UMLS CUI [1])
Cardiovascular Abnormalities | Uncontrolled hypertension | Congestive heart failure New York Heart Association Classification | Angina, Unstable | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction
Item
history or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure nyha classification of 3, unstable angina or poorly controlled arrhythmia. myocardial infarction within 6 months prior to randomisation.
boolean
C0243050 (UMLS CUI [1])
C1868885 (UMLS CUI [2])
C0018802 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5,1])
C3853134 (UMLS CUI [5,2])
C0027051 (UMLS CUI [6])
Left Ventricular Function | EJECTION FRACTION RESTING
Item
cardiac left ventricular function with resting ejection fraction of less than 50%.
boolean
C0080310 (UMLS CUI [1])
C0743403 (UMLS CUI [2])
Protocol Compliance Unable
Item
patients unable to comply with the protocol.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Medical contraindication Vinorelbine | Medical contraindication Trastuzumab
Item
any contraindications for therapy with vinorelbine or trastuzumab.
boolean
C1301624 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
Hypersensitivity BIBW 2992 | Hypersensitivity Investigational New Drug Excipient
Item
known hypersensitivity to bibw 2992 or the excipients of any of the trial drugs.
boolean
C0020517 (UMLS CUI [1,1])
C4083270 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Use of Investigational New Drugs Recently
Item
use of any investigational drug within 4 weeks of randomisation.
boolean
C1524063 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Liver function Inadequate | Renal function Inadequate | Hematologic function Inadequate
Item
inadequate hepatic, renal and haematologic organ function
boolean
C0232741 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
C0232804 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0221130 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
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