ID

38177

Descripción

Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2; ODM derived from: https://clinicaltrials.gov/show/NCT01996267

Link

https://clinicaltrials.gov/show/NCT01996267

Palabras clave

Versiones (1)
  1. 24/9/19 24/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

24 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01996267

Inglés

Eligibility Breast Cancer NCT01996267

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed infiltrating breast cancer
Descripción

Invasive carcinoma of breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0853879
stage ii or stage iii disease. nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or fdg-pet scan.
Descripción

Disease TNM Breast tumor staging | Lymph nodal status Ultrasonography | Lymph nodal status Fine needle aspiration biopsy | Lymph nodal status Sentinel Lymph Node Biopsy | Lymph nodal status FDG-PET Scanning

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0474926
UMLS CUI [2,1]
C0449927
UMLS CUI [2,2]
C0041618
UMLS CUI [3,1]
C0449927
UMLS CUI [3,2]
C1510483
UMLS CUI [4,1]
C0449927
UMLS CUI [4,2]
C0796693
UMLS CUI [5,1]
C0449927
UMLS CUI [5,2]
C3899175
overexpression and/or amplification of her2 in an invasive component of the core biopsy, according to one of the following definitions:
Descripción

HER2 Overexpression | HER2 gene amplification | Component Invasive Core needle biopsy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [2]
C1512127
UMLS CUI [3,1]
C1705248
UMLS CUI [3,2]
C0205281
UMLS CUI [3,3]
C1318309
•>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
Descripción

Neoplastic Cell Invasive Percentage | Tissue membrane Circumferential Complete Staining | Score

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0597032
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0025255
UMLS CUI [2,2]
C0205113
UMLS CUI [2,3]
C0205197
UMLS CUI [2,4]
C1704680
UMLS CUI [3]
C0449820
•her2 gene amplification defined as >6 her2 gene copies per nucleus by in situ hybridization.
Descripción

HER2 gene amplification | Gene copy number In Situ Hybridization

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1512127
UMLS CUI [2,1]
C0178655
UMLS CUI [2,2]
C0162788
age ≥18
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group performance status ≤1
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function (anc >1.5 x 109/l, platelets >100 x 109/l)
Descripción

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
adequate hepatic function (alat, asat and bilirubin <2.5 times upper limit of normal)
Descripción

Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
adequate renal function (creatinine clearance >50 ml/min)
Descripción

Renal function | Creatinine measurement, serum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
lvef ≥50% measured by echocardiography or muga
Descripción

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Descripción

Absence Mental condition Interferes with Protocol Compliance | Absence Factor Familial Interferes with Protocol Compliance | Absence Sociological Factors Interfere with Protocol Compliance | Absence Geographic Factors Interfere with Protocol Compliance | Absence Mental condition Interferes with Follow-up | Absence Factor Familial Interferes with Follow-up | Absence Sociological Factors Interfere with Follow-up | Absence Geographic Factors Interfere with Follow-up

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3840291
UMLS CUI [1,3]
C0521102
UMLS CUI [1,4]
C0525058
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1521761
UMLS CUI [2,3]
C0241888
UMLS CUI [2,4]
C0521102
UMLS CUI [2,5]
C0525058
UMLS CUI [3,1]
C0332197
UMLS CUI [3,2]
C3850138
UMLS CUI [3,3]
C0521102
UMLS CUI [3,4]
C0525058
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0017444
UMLS CUI [4,3]
C0521102
UMLS CUI [4,4]
C0525058
UMLS CUI [5,1]
C0332197
UMLS CUI [5,2]
C3840291
UMLS CUI [5,3]
C0521102
UMLS CUI [5,4]
C3274571
UMLS CUI [6,1]
C0332197
UMLS CUI [6,2]
C1521761
UMLS CUI [6,3]
C0241888
UMLS CUI [6,4]
C0521102
UMLS CUI [6,5]
C3274571
UMLS CUI [7,1]
C0332197
UMLS CUI [7,2]
C3850138
UMLS CUI [7,3]
C0521102
UMLS CUI [7,4]
C3274571
UMLS CUI [8,1]
C0332197
UMLS CUI [8,2]
C0017444
UMLS CUI [8,3]
C0521102
UMLS CUI [8,4]
C3274571
absence of any medical condition that would place the patient at unusual risk.
Descripción

Absence Medical condition Patient At risk

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C3843040
UMLS CUI [1,3]
C0030705
UMLS CUI [1,4]
C1444641
signed written informed consent
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous radiation therapy or chemotherapy
Descripción

Prior radiation therapy | Prior Chemotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0279134
UMLS CUI [2]
C1514457
other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
Descripción

Cancer Other | Exception Carcinoma in Situ | Exception Curative treatment Cancer Other | Chemotherapy Absent | Therapeutic radiology procedure Absent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007099
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C1707251
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C1522449
UMLS CUI [5,2]
C0332197
current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection
Descripción

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
evidence of distant metastases. evaluation of the presence of distant metastases may include chest x-ray, liver ultrasound, isotope bone-scan, ct-scan of chest and abdomen and/or fdg-pet scan, according to local procedures.
Descripción

Distant metastasis Chest X-ray | Distant metastasis Ultrasonography of liver | Distant metastasis Radioisotope scan of bone | Distant metastasis CT of chest and abdomen | Distant metastasis FDG-PET Scanning

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1269798
UMLS CUI [1,2]
C0039985
UMLS CUI [2,1]
C1269798
UMLS CUI [2,2]
C0412534
UMLS CUI [3,1]
C1269798
UMLS CUI [3,2]
C0203668
UMLS CUI [4,1]
C1269798
UMLS CUI [4,2]
C1630402
UMLS CUI [5,1]
C1269798
UMLS CUI [5,2]
C3899175
evidence of bilateral infiltrating breast cancer. evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or mri breast.
Descripción

Invasive carcinoma of breast Bilateral Mammography | Invasive carcinoma of breast Bilateral Mammary Ultrasonography | Invasive carcinoma of breast Bilateral MRI of breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0238767
UMLS CUI [1,3]
C0024671
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0238767
UMLS CUI [2,3]
C0080264
UMLS CUI [3,1]
C0853879
UMLS CUI [3,2]
C0238767
UMLS CUI [3,3]
C0344104
concurrent anti-cancer treatment or another investigational drug.
Descripción

Cancer treatment | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
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Similar models

Eligibility Breast Cancer NCT01996267

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
histologically confirmed infiltrating breast cancer
boolean
C0853879 (UMLS CUI [1])
Disease TNM Breast tumor staging | Lymph nodal status Ultrasonography | Lymph nodal status Fine needle aspiration biopsy | Lymph nodal status Sentinel Lymph Node Biopsy | Lymph nodal status FDG-PET Scanning
Item
stage ii or stage iii disease. nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or fdg-pet scan.
boolean
C0012634 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0449927 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
C0449927 (UMLS CUI [3,1])
C1510483 (UMLS CUI [3,2])
C0449927 (UMLS CUI [4,1])
C0796693 (UMLS CUI [4,2])
C0449927 (UMLS CUI [5,1])
C3899175 (UMLS CUI [5,2])
HER2 Overexpression | HER2 gene amplification | Component Invasive Core needle biopsy
Item
overexpression and/or amplification of her2 in an invasive component of the core biopsy, according to one of the following definitions:
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C1512127 (UMLS CUI [2])
C1705248 (UMLS CUI [3,1])
C0205281 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])
Neoplastic Cell Invasive Percentage | Tissue membrane Circumferential Complete Staining | Score
Item
•>30% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
boolean
C0597032 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0025255 (UMLS CUI [2,1])
C0205113 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C1704680 (UMLS CUI [2,4])
C0449820 (UMLS CUI [3])
HER2 gene amplification | Gene copy number In Situ Hybridization
Item
•her2 gene amplification defined as >6 her2 gene copies per nucleus by in situ hybridization.
boolean
C1512127 (UMLS CUI [1])
C0178655 (UMLS CUI [2,1])
C0162788 (UMLS CUI [2,2])
Age
Item
age ≥18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group performance status ≤1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow function (anc >1.5 x 109/l, platelets >100 x 109/l)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Liver function | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Serum total bilirubin measurement
Item
adequate hepatic function (alat, asat and bilirubin <2.5 times upper limit of normal)
boolean
C0232741 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C1278039 (UMLS CUI [4])
Renal function | Creatinine measurement, serum
Item
adequate renal function (creatinine clearance >50 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
lvef ≥50% measured by echocardiography or muga
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Absence Mental condition Interferes with Protocol Compliance | Absence Factor Familial Interferes with Protocol Compliance | Absence Sociological Factors Interfere with Protocol Compliance | Absence Geographic Factors Interfere with Protocol Compliance | Absence Mental condition Interferes with Follow-up | Absence Factor Familial Interferes with Follow-up | Absence Sociological Factors Interfere with Follow-up | Absence Geographic Factors Interfere with Follow-up
Item
absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0332197 (UMLS CUI [1,1])
C3840291 (UMLS CUI [1,2])
C0521102 (UMLS CUI [1,3])
C0525058 (UMLS CUI [1,4])
C0332197 (UMLS CUI [2,1])
C1521761 (UMLS CUI [2,2])
C0241888 (UMLS CUI [2,3])
C0521102 (UMLS CUI [2,4])
C0525058 (UMLS CUI [2,5])
C0332197 (UMLS CUI [3,1])
C3850138 (UMLS CUI [3,2])
C0521102 (UMLS CUI [3,3])
C0525058 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0017444 (UMLS CUI [4,2])
C0521102 (UMLS CUI [4,3])
C0525058 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C3840291 (UMLS CUI [5,2])
C0521102 (UMLS CUI [5,3])
C3274571 (UMLS CUI [5,4])
C0332197 (UMLS CUI [6,1])
C1521761 (UMLS CUI [6,2])
C0241888 (UMLS CUI [6,3])
C0521102 (UMLS CUI [6,4])
C3274571 (UMLS CUI [6,5])
C0332197 (UMLS CUI [7,1])
C3850138 (UMLS CUI [7,2])
C0521102 (UMLS CUI [7,3])
C3274571 (UMLS CUI [7,4])
C0332197 (UMLS CUI [8,1])
C0017444 (UMLS CUI [8,2])
C0521102 (UMLS CUI [8,3])
C3274571 (UMLS CUI [8,4])
Absence Medical condition Patient At risk
Item
absence of any medical condition that would place the patient at unusual risk.
boolean
C0332197 (UMLS CUI [1,1])
C3843040 (UMLS CUI [1,2])
C0030705 (UMLS CUI [1,3])
C1444641 (UMLS CUI [1,4])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Prior radiation therapy | Prior Chemotherapy
Item
previous radiation therapy or chemotherapy
boolean
C0279134 (UMLS CUI [1])
C1514457 (UMLS CUI [2])
Cancer Other | Exception Carcinoma in Situ | Exception Curative treatment Cancer Other | Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
other malignancy except carcinoma in situ, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007099 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C1707251 (UMLS CUI [3,3])
C0392920 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C1522449 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
Distant metastasis Chest X-ray | Distant metastasis Ultrasonography of liver | Distant metastasis Radioisotope scan of bone | Distant metastasis CT of chest and abdomen | Distant metastasis FDG-PET Scanning
Item
evidence of distant metastases. evaluation of the presence of distant metastases may include chest x-ray, liver ultrasound, isotope bone-scan, ct-scan of chest and abdomen and/or fdg-pet scan, according to local procedures.
boolean
C1269798 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C1269798 (UMLS CUI [2,1])
C0412534 (UMLS CUI [2,2])
C1269798 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
C1269798 (UMLS CUI [4,1])
C1630402 (UMLS CUI [4,2])
C1269798 (UMLS CUI [5,1])
C3899175 (UMLS CUI [5,2])
Invasive carcinoma of breast Bilateral Mammography | Invasive carcinoma of breast Bilateral Mammary Ultrasonography | Invasive carcinoma of breast Bilateral MRI of breast
Item
evidence of bilateral infiltrating breast cancer. evaluation of the presence of bilateral infiltrating breast cancer may include mammography, breast ultrasound and/or mri breast.
boolean
C0853879 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0024671 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C0238767 (UMLS CUI [2,2])
C0080264 (UMLS CUI [2,3])
C0853879 (UMLS CUI [3,1])
C0238767 (UMLS CUI [3,2])
C0344104 (UMLS CUI [3,3])
Cancer treatment | Investigational New Drugs
Item
concurrent anti-cancer treatment or another investigational drug.
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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