ID

38234

Description

Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib; ODM derived from: https://clinicaltrials.gov/show/NCT02056080

Link

https://clinicaltrials.gov/show/NCT02056080

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 Neoplasm NCT02056080

English

Eligibility Breast Neoplasm NCT02056080

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed diagnosis of metastatic breast cancer her2-positive phenotype (confirmed by ihc 3 + or fish positive)
Description

Secondary malignant neoplasm of female breast HER2 Positive Immunohistochemistry | Secondary malignant neoplasm of female breast HER2 Positive FISH Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C2348909
UMLS CUI [2,3]
C0162789
UMLS CUI [2,4]
C1514241
older than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
progressed to at least one prior treatment line for mbc with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
Description

Prior Therapy Quantity Secondary malignant neoplasm of female breast | trastuzumab | lapatinib | Combined Modality Therapy | Chemotherapy | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
UMLS CUI [2]
C0728747
UMLS CUI [3]
C1506770
UMLS CUI [4]
C0009429
UMLS CUI [5]
C0392920
UMLS CUI [6]
C0279025
having the patient's complete medical history that contains all lines antiher2 therapy treatment
Description

Medical History | Targeted Therapy HER2 Quantity

Data type

boolean

Alias
UMLS CUI [1]
C0262926
UMLS CUI [2,1]
C2985566
UMLS CUI [2,2]
C0069515
UMLS CUI [2,3]
C1265611
being a patient who initiated the combination of trastuzumab and lapatinib between january 2005 and december 2011
Description

Initiation Lapatinib/Trastuzumab Regimen

Data type

boolean

Alias
UMLS CUI [1,1]
C1704686
UMLS CUI [1,2]
C1541246
inform the patient and get the signature of the informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
not having phenotypic classification of the tumor by ihc or fish test for her2
Description

Absence Immunohistochemistry Neoplasm HER2 | Absence FISH Neoplasm HER2

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0021044
UMLS CUI [1,3]
C0027651
UMLS CUI [1,4]
C0069515
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0162789
UMLS CUI [2,3]
C0027651
UMLS CUI [2,4]
C0069515
being a patient with her2-negative phenotype(fish negative or ihc in range [0-2 +] without fish)
Description

Patient HER2 Negative FISH Negative | Patient HER2 Negative Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C2348908
UMLS CUI [1,3]
C0162789
UMLS CUI [1,4]
C1513916
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C2348908
UMLS CUI [2,3]
C0021044
being a patient who received the trastuzumab and/or lapatinib treatment (tl) in combination with chemotherapy
Description

Lapatinib/Trastuzumab Regimen | Chemotherapy | Combined Modality Therapy

Data type

boolean

Alias
UMLS CUI [1]
C1541246
UMLS CUI [2]
C0392920
UMLS CUI [3]
C0009429
being a patient who, since january 2012, began tl therapy for metastatic disease.
Description

Lapatinib/Trastuzumab Regimen Neoplasm Metastasis | Start time

Data type

boolean

Alias
UMLS CUI [1,1]
C1541246
UMLS CUI [1,2]
C0027627
UMLS CUI [2]
C1301880
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Similar models

Eligibility Breast Neoplasm NCT02056080

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast HER2 Positive Immunohistochemistry | Secondary malignant neoplasm of female breast HER2 Positive FISH Positive
Item
confirmed diagnosis of metastatic breast cancer her2-positive phenotype (confirmed by ihc 3 + or fish positive)
boolean
C0346993 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0346993 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
C1514241 (UMLS CUI [2,4])
Age
Item
older than 18 years
boolean
C0001779 (UMLS CUI [1])
Prior Therapy Quantity Secondary malignant neoplasm of female breast | trastuzumab | lapatinib | Combined Modality Therapy | Chemotherapy | Hormone Therapy
Item
progressed to at least one prior treatment line for mbc with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C0728747 (UMLS CUI [2])
C1506770 (UMLS CUI [3])
C0009429 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
Medical History | Targeted Therapy HER2 Quantity
Item
having the patient's complete medical history that contains all lines antiher2 therapy treatment
boolean
C0262926 (UMLS CUI [1])
C2985566 (UMLS CUI [2,1])
C0069515 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
Initiation Lapatinib/Trastuzumab Regimen
Item
being a patient who initiated the combination of trastuzumab and lapatinib between january 2005 and december 2011
boolean
C1704686 (UMLS CUI [1,1])
C1541246 (UMLS CUI [1,2])
Informed Consent
Item
inform the patient and get the signature of the informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Absence Immunohistochemistry Neoplasm HER2 | Absence FISH Neoplasm HER2
Item
not having phenotypic classification of the tumor by ihc or fish test for her2
boolean
C0332197 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0027651 (UMLS CUI [1,3])
C0069515 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
C0027651 (UMLS CUI [2,3])
C0069515 (UMLS CUI [2,4])
Patient HER2 Negative FISH Negative | Patient HER2 Negative Immunohistochemistry
Item
being a patient with her2-negative phenotype(fish negative or ihc in range [0-2 +] without fish)
boolean
C0030705 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0162789 (UMLS CUI [1,3])
C1513916 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
Lapatinib/Trastuzumab Regimen | Chemotherapy | Combined Modality Therapy
Item
being a patient who received the trastuzumab and/or lapatinib treatment (tl) in combination with chemotherapy
boolean
C1541246 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
C0009429 (UMLS CUI [3])
Lapatinib/Trastuzumab Regimen Neoplasm Metastasis | Start time
Item
being a patient who, since january 2012, began tl therapy for metastatic disease.
boolean
C1541246 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1301880 (UMLS CUI [2])
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