ID

23482

Beskrivning

Lapatinib in Combination With Trastuzumab in Patients With HER2-Positive, Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00470704

Länk

https://clinicaltrials.gov/show/NCT00470704

Nyckelord

Versioner (1)
  1. 2017-07-07 2017-07-07 -
Uppladdad den

7 juli 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00470704

Engelsk

Eligibility Breast Cancer NCT00470704

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed invasive breast cancer, with stage iv disease
Beskrivning

Invasive carcinoma of breast TNM clinical staging

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C3258246
her2-positive breast cancer, defined as 3+ staining by ihc or gene amplification by fish
Beskrivning

HER2-positive carcinoma of breast | Staining method Immunohistochemistry | Gene Amplification Fluorescent in Situ Hybridization

Datatyp

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2,1]
C0487602
UMLS CUI [2,2]
C0021044
UMLS CUI [3,1]
C0017256
UMLS CUI [3,2]
C0162789
measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
Beskrivning

Measurable Disease | Lesion Quantity | Measurement Dimension Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0242485
UMLS CUI [3,2]
C0439534
UMLS CUI [3,3]
C1265611
willingness to undergo a research biopsy of recurrent or metastatic disease
Beskrivning

Recurrent disease Biopsy Willing | Neoplasm Metastasis Biopsy Willing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0005558
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0005558
UMLS CUI [2,3]
C0600109
prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry.
Beskrivning

Chemotherapy To be stopped

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1272691
completed radiation therapy at least 7 days prior to beginning protocol treatment
Beskrivning

Therapeutic radiology procedure Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C0205197
cohort 1: no prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other her2-directed therapy other than trastuzumab
Beskrivning

Advanced breast cancer | Chemotherapy Absent | Trastuzumab Absent | Lapatinib Absent | HER2 Targeted Therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C3495917
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C1506770
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0069515
UMLS CUI [5,2]
C2985566
UMLS CUI [5,3]
C0332197
cohort 2: up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other her2-directed therapy except for trastuzumab
Beskrivning

Chemotherapy Quantity Advanced breast cancer | Lapatinib Absent | HER2 Targeted Therapy Absent | Trastuzumab Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C3495917
UMLS CUI [2,1]
C1506770
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C2985566
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C2828389
18 years of age or older
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy of greater than 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
ecog performance status 0-2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
normal organ and marrow function as outlined in protocol
Beskrivning

Organ function | Bone Marrow function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
cardiac ejection fraction, as assessed by either muga scan or echocardiogram greater than or equal to 50%
Beskrivning

Cardiac ejection fraction | Multiple gated acquisition scanning | Echocardiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
UMLS CUI [2]
C0521317
UMLS CUI [3]
C0013516
able to take oral medications
Beskrivning

Able to swallow oral medication

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease
Beskrivning

Investigational New Drugs Neoplasm Metastasis | Chemotherapy Neoplasm Metastasis | Hormone Therapy Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C0027627
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0027627
active brain metastases
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study
Beskrivning

Allergic Reaction Lapatinib Compound Similar | Allergic Reaction Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1506770
UMLS CUI [1,3]
C1706082
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
clinically significant malabsorption syndrome
Beskrivning

Malabsorption Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0024523
uncontrolled intercurrent illness
Beskrivning

Comorbidity Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
pregnant or breastfeeding women
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent use of the medications listed in the protocol because of possible interaction with lapatinib
Beskrivning

Pharmaceutical Preparations Study Protocol Interaction Lapatinib

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0687133
UMLS CUI [1,4]
C1506770
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Similar models

Eligibility Breast Cancer NCT00470704

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast TNM clinical staging
Item
histologically or cytologically confirmed invasive breast cancer, with stage iv disease
boolean
C0853879 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
HER2-positive carcinoma of breast | Staining method Immunohistochemistry | Gene Amplification Fluorescent in Situ Hybridization
Item
her2-positive breast cancer, defined as 3+ staining by ihc or gene amplification by fish
boolean
C1960398 (UMLS CUI [1])
C0487602 (UMLS CUI [2,1])
C0021044 (UMLS CUI [2,2])
C0017256 (UMLS CUI [3,1])
C0162789 (UMLS CUI [3,2])
Measurable Disease | Lesion Quantity | Measurement Dimension Quantity
Item
measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension
boolean
C1513041 (UMLS CUI [1])
C0221198 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0242485 (UMLS CUI [3,1])
C0439534 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Recurrent disease Biopsy Willing | Neoplasm Metastasis Biopsy Willing
Item
willingness to undergo a research biopsy of recurrent or metastatic disease
boolean
C0277556 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0005558 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Chemotherapy To be stopped
Item
prior chemotherapy treatment must be discontinued for at least 2 weeks prior to study entry.
boolean
C0392920 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Therapeutic radiology procedure Completed
Item
completed radiation therapy at least 7 days prior to beginning protocol treatment
boolean
C1522449 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Advanced breast cancer | Chemotherapy Absent | Trastuzumab Absent | Lapatinib Absent | HER2 Targeted Therapy Absent
Item
cohort 1: no prior chemotherapy for advanced breast cancer; no prior trastuzumab in the advanced breast cancer setting; nor prior treatment with lapatinib or other her2-directed therapy other than trastuzumab
boolean
C3495917 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C1506770 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0069515 (UMLS CUI [5,1])
C2985566 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Chemotherapy Quantity Advanced breast cancer | Lapatinib Absent | HER2 Targeted Therapy Absent | Trastuzumab Excluded
Item
cohort 2: up to two prior chemotherapy regimens for the treatment of advanced breast cancer; no prior treatment with lapatinib or other her2-directed therapy except for trastuzumab
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495917 (UMLS CUI [1,3])
C1506770 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0069515 (UMLS CUI [3,1])
C2985566 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0728747 (UMLS CUI [4,1])
C2828389 (UMLS CUI [4,2])
Age
Item
18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of greater than 12 weeks
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
normal organ and marrow function as outlined in protocol
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Cardiac ejection fraction | Multiple gated acquisition scanning | Echocardiography
Item
cardiac ejection fraction, as assessed by either muga scan or echocardiogram greater than or equal to 50%
boolean
C0232174 (UMLS CUI [1])
C0521317 (UMLS CUI [2])
C0013516 (UMLS CUI [3])
Able to swallow oral medication
Item
able to take oral medications
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Investigational New Drugs Neoplasm Metastasis | Chemotherapy Neoplasm Metastasis | Hormone Therapy Neoplasm Metastasis
Item
patients may not be receiving any other investigational agents or concurrent chemotherapy or hormonal therapy for treatment of metastatic disease
boolean
C0013230 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
C0279025 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
Metastatic malignant neoplasm to brain
Item
active brain metastases
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Lapatinib Compound Similar | Allergic Reaction Investigational New Drugs
Item
history of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib or other agents used in this study
boolean
C1527304 (UMLS CUI [1,1])
C1506770 (UMLS CUI [1,2])
C1706082 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Malabsorption Syndrome
Item
clinically significant malabsorption syndrome
boolean
C0024523 (UMLS CUI [1])
Comorbidity Uncontrolled
Item
uncontrolled intercurrent illness
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Pharmaceutical Preparations Study Protocol Interaction Lapatinib
Item
concurrent use of the medications listed in the protocol because of possible interaction with lapatinib
boolean
C0013227 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0687133 (UMLS CUI [1,3])
C1506770 (UMLS CUI [1,4])
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