ID

31030

Beskrivning

Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells; ODM derived from: https://clinicaltrials.gov/show/NCT00820924

Länk

https://clinicaltrials.gov/show/NCT00820924

Nyckelord

Versioner (1)
  1. 2018-07-12 2018-07-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 juli 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Neoplasms, Breast NCT00820924

Engelsk

Eligibility Neoplasms, Breast NCT00820924

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients at least 18 years old with her-2 negative breast cancer.
Beskrivning

Gender | Age | HER2 negative carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
UMLS CUI [3]
C2316304
patients must have evidence of her-2 or egfr positive circulating tumour cells in a peripheral blood sample taken at screening visit.
Beskrivning

Circulating Neoplastic Cells HER2 Positive Peripheral blood specimen | Circulating Neoplastic Cells EGFR Positive Peripheral blood specimen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027625
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C1292451
UMLS CUI [2,1]
C0027625
UMLS CUI [2,2]
C4525189
UMLS CUI [2,3]
C1292451
patients must have measurable, metastatic disease and no brain metastasis requiring local therapy.
Beskrivning

Neoplasm Metastasis Measurable | Absence Metastatic malignant neoplasm to brain Requirement Local Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1513040
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0220650
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C1517925
other criteria include ecog score 0 to 2, life expectancy > 12 weeks, baseline organ function at screening visit,
Beskrivning

ECOG performance status | Life Expectancy | Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
UMLS CUI [2]
C0023671
UMLS CUI [3]
C0678852
previous treatment with anthracyclines and/or taxanes in the neo-adjuvant, adjuvant or advanced setting, and at least one line of treatment for metastatic disease.
Beskrivning

Anthracyclines | Taxanes | Neoadjuvant Therapy | Adjuvant therapy | Advanced phase | Line of Therapy Quantity Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0282564
UMLS CUI [2]
C0796419
UMLS CUI [3]
C0600558
UMLS CUI [4]
C0677850
UMLS CUI [5]
C0205179
UMLS CUI [6,1]
C4524693
UMLS CUI [6,2]
C1265611
UMLS CUI [6,3]
C0027627
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
unstable medical conditions, pregnant or lactating women.
Beskrivning

Medical condition Unstable | Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0006147
inability to provide informed consent.
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
lack of physical integrity of the upper gastrointestinal (gi) tract.
Beskrivning

Integrity Physical Lacking Upper gastrointestinal tract

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1947912
UMLS CUI [1,2]
C0205485
UMLS CUI [1,3]
C0332268
UMLS CUI [1,4]
C1268997
co-existing malignancy or malignancies within the last 5 years with the exception of basal cell carcinoma or in-situ carcinoma, concurrent anti-cancer therapies (chemo or hormonal therapy) or investigational drugs other than study drug.
Beskrivning

Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in Situ | Exception Cancer treatment Concurrent | Exception Chemotherapy | Exception Hormone Therapy | Exception Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007099
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0920425
UMLS CUI [4,3]
C0205420
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0392920
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0279025
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0013230
concurrent radiotherapy to the only target lesion or concurrent bisphosphonates if bone metastases are the only target lesions.
Beskrivning

Therapeutic radiology procedure Target Lesion Only | Diphosphonates | Secondary malignant neoplasm of bone Target Lesion Only

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C2986546
UMLS CUI [1,3]
C0205171
UMLS CUI [2]
C0012544
UMLS CUI [3,1]
C0153690
UMLS CUI [3,2]
C2986546
UMLS CUI [3,3]
C0205171
previous treatment with anti her-2 or anti-egfr therapies.
Beskrivning

Therapeutic procedure Against HER2 | Therapeutic procedure Against EGFR

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0069515
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0521124
UMLS CUI [2,3]
C0034802
protocol specified treatment regimens that would be inappropriate for the management of the subject.
Beskrivning

Therapeutic procedure Inappropriate Patient Care Management

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0030677
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Similar models

Eligibility Neoplasms, Breast NCT00820924

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age | HER2 negative carcinoma of breast
Item
female patients at least 18 years old with her-2 negative breast cancer.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C2316304 (UMLS CUI [3])
Circulating Neoplastic Cells HER2 Positive Peripheral blood specimen | Circulating Neoplastic Cells EGFR Positive Peripheral blood specimen
Item
patients must have evidence of her-2 or egfr positive circulating tumour cells in a peripheral blood sample taken at screening visit.
boolean
C0027625 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1292451 (UMLS CUI [1,3])
C0027625 (UMLS CUI [2,1])
C4525189 (UMLS CUI [2,2])
C1292451 (UMLS CUI [2,3])
Neoplasm Metastasis Measurable | Absence Metastatic malignant neoplasm to brain Requirement Local Therapy
Item
patients must have measurable, metastatic disease and no brain metastasis requiring local therapy.
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C0220650 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C1517925 (UMLS CUI [2,4])
ECOG performance status | Life Expectancy | Organ function
Item
other criteria include ecog score 0 to 2, life expectancy > 12 weeks, baseline organ function at screening visit,
boolean
C1520224 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
C0678852 (UMLS CUI [3])
Anthracyclines | Taxanes | Neoadjuvant Therapy | Adjuvant therapy | Advanced phase | Line of Therapy Quantity Neoplasm Metastasis
Item
previous treatment with anthracyclines and/or taxanes in the neo-adjuvant, adjuvant or advanced setting, and at least one line of treatment for metastatic disease.
boolean
C0282564 (UMLS CUI [1])
C0796419 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
C0677850 (UMLS CUI [4])
C0205179 (UMLS CUI [5])
C4524693 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0027627 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Medical condition Unstable | Pregnancy | Breast Feeding
Item
unstable medical conditions, pregnant or lactating women.
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Informed Consent Unable
Item
inability to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Integrity Physical Lacking Upper gastrointestinal tract
Item
lack of physical integrity of the upper gastrointestinal (gi) tract.
boolean
C1947912 (UMLS CUI [1,1])
C0205485 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
C1268997 (UMLS CUI [1,4])
Malignant Neoplasms | Exception Basal cell carcinoma | Exception Carcinoma in Situ | Exception Cancer treatment Concurrent | Exception Chemotherapy | Exception Hormone Therapy | Exception Investigational New Drugs
Item
co-existing malignancy or malignancies within the last 5 years with the exception of basal cell carcinoma or in-situ carcinoma, concurrent anti-cancer therapies (chemo or hormonal therapy) or investigational drugs other than study drug.
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007099 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0920425 (UMLS CUI [4,2])
C0205420 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0392920 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0279025 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0013230 (UMLS CUI [7,2])
Therapeutic radiology procedure Target Lesion Only | Diphosphonates | Secondary malignant neoplasm of bone Target Lesion Only
Item
concurrent radiotherapy to the only target lesion or concurrent bisphosphonates if bone metastases are the only target lesions.
boolean
C1522449 (UMLS CUI [1,1])
C2986546 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
C0012544 (UMLS CUI [2])
C0153690 (UMLS CUI [3,1])
C2986546 (UMLS CUI [3,2])
C0205171 (UMLS CUI [3,3])
Therapeutic procedure Against HER2 | Therapeutic procedure Against EGFR
Item
previous treatment with anti her-2 or anti-egfr therapies.
boolean
C0087111 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0069515 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0521124 (UMLS CUI [2,2])
C0034802 (UMLS CUI [2,3])
Therapeutic procedure Inappropriate Patient Care Management
Item
protocol specified treatment regimens that would be inappropriate for the management of the subject.
boolean
C0087111 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0030677 (UMLS CUI [1,3])
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