ID

26632

Beschreibung

Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study; ODM derived from: https://clinicaltrials.gov/show/NCT00768859

Link

https://clinicaltrials.gov/show/NCT00768859

Stichworte

Versionen (2)
  1. 19.10.17 19.10.17 -
  2. 22.10.17 22.10.17 -
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See clinicaltrials.gov

Hochgeladen am

22. Oktober 2017

DOI

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Eligibility Breast Cancer NCT00768859

Englisch

Eligibility Breast Cancer NCT00768859

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically or cytologically confirmed infiltrating breast cancer.
Beschreibung

invasive breast cancer

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
stage ii or stage iii breast cancer.28 'locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. n1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of >2 mm in diameter at sentinel node biopsy. stage iia patients are eligible if the tumor is >3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
Beschreibung

Breast Carcinoma TNM Breast tumor staging | Locally advanced breast cancer | Secondary malignant neoplasm of lymph node Supraclavicular Ipsilateral | TNM clinical staging | Fine needle aspiration of axillary lymph node | AXILLARY LYMPH NODE METASTASIS Diameter Sentinel Lymph Node Biopsy | Neoplasm Diameter | Breast-Conserving Surgery Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C3495949
UMLS CUI [3,1]
C0686619
UMLS CUI [3,2]
C0229730
UMLS CUI [3,3]
C0441989
UMLS CUI [4]
C3258246
UMLS CUI [5]
C0398445
UMLS CUI [6,1]
C0741344
UMLS CUI [6,2]
C1301886
UMLS CUI [6,3]
C0796693
UMLS CUI [7,1]
C0027651
UMLS CUI [7,2]
C1301886
UMLS CUI [8,1]
C0917927
UMLS CUI [8,2]
C1272705
overexpression and/or amplification of her2 in an invasive component of the core biopsy, according to one of the following definitions:
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [2]
C1512127
UMLS CUI [3,1]
C1334274
UMLS CUI [3,2]
C1705248
UMLS CUI [3,3]
C1318309
>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
Beschreibung

Invasive Carcinoma Cells Percentage | Membrane Staining Strong | Score Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1334274
UMLS CUI [1,2]
C0007634
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C3161472
UMLS CUI [2,2]
C1704680
UMLS CUI [2,3]
C0442821
UMLS CUI [3,1]
C0449820
UMLS CUI [3,2]
C1514241
>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating her2 gene amplification defined as a fish ratio of her2 gene copies to chromosome 17 signals of >2.2. or as >5 her2 gene copies per nucleus in cish analysis.
Beschreibung

Invasive Carcinoma Cells Percentage | Membrane Staining Moderate | Score Moderate | HER2 gene amplification | HER2/CEP17 Ratio FISH | CISH

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1334274
UMLS CUI [1,2]
C0007634
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C3161472
UMLS CUI [2,2]
C1704680
UMLS CUI [2,3]
C0205081
UMLS CUI [3,1]
C0449820
UMLS CUI [3,2]
C0205081
UMLS CUI [4]
C1512127
UMLS CUI [5]
C1977461
UMLS CUI [6]
C1516514
patients with a negative or equivocal overall result (fish test ratio of <2.2, <6.0 her2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by ihc are not eligible for participation in the trial.
Beschreibung

Test result Negative Ineligible | Test result Equivocal Ineligible | HER2/CEP17 Ratio FISH | CISH | Staining Score Immunohistochemistry | Neoplastic Cells Percentage

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0587081
UMLS CUI [1,2]
C1513916
UMLS CUI [1,3]
C1512714
UMLS CUI [2,1]
C0587081
UMLS CUI [2,2]
C0332241
UMLS CUI [2,3]
C1512714
UMLS CUI [3]
C1977461
UMLS CUI [4]
C1516514
UMLS CUI [5,1]
C1704680
UMLS CUI [5,2]
C0449820
UMLS CUI [5,3]
C0021044
UMLS CUI [6,1]
C0597032
UMLS CUI [6,2]
C0439165
age ≥18
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status ≤1 (appendix b)
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow function (anc >1.0 x 109/l, platelets >100 x 109/l)
Beschreibung

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement

Datentyp

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 times upper limit of normal)
Beschreibung

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

Datentyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
UMLS CUI [4]
C1278039
adequate renal function (creatinine clearance >60 ml/min)
Beschreibung

Renal function | Creatinine clearance measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0373595
lvef ≥50% measured by echocardiography or muga
Beschreibung

Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0013516
UMLS CUI [3]
C0521317
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Beschreibung

Condition Preventing Protocol Compliance

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
signed written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
no previous radiation therapy or chemotherapy
Beschreibung

Therapeutic radiology procedure | Chemotherapy

Datentyp

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0392920
no other malignancy except carcinoma in situ, unless the other malignancy was treated
Beschreibung

Cancer Other | Exception Carcinoma in Situ | Exception Curative treatment Other Cancer

Datentyp

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
≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
Beschreibung

Chemotherapy Absent | Therapeutic radiology procedure Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C1522449
UMLS CUI [2,2]
C0332197
no current pregnancy or breastfeeding. women of childbearing potential must use adequate contraceptive protection.
Beschreibung

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
no evidence of distant metastases. staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. abnormal uptake on the isotope bone scan can only be accepted if mri, ct-scan, or plain radiograph excludes bone metastases.
Beschreibung

Distant metastasis | TNM Breast tumor staging | Plain chest X-ray | Liver Ultrasonography | Radioisotope scan of bone | Secondary malignant neoplasm of bone Absent | MRI | CT scan

Datentyp

boolean

Alias
UMLS CUI [1]
C1269798
UMLS CUI [2]
C0474926
UMLS CUI [3]
C0039985
UMLS CUI [4,1]
C0023884
UMLS CUI [4,2]
C0041618
UMLS CUI [5]
C0203668
UMLS CUI [6,1]
C0153690
UMLS CUI [6,2]
C0332197
UMLS CUI [7]
C0024485
UMLS CUI [8]
C0040405
no concurrent anti-cancer treatment or another investigational drug
Beschreibung

Cancer treatment | Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0013230
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Ähnliche Modelle

Eligibility Breast Cancer NCT00768859

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
invasive breast cancer
Item
histologically or cytologically confirmed infiltrating breast cancer.
boolean
C0853879 (UMLS CUI [1])
Breast Carcinoma TNM Breast tumor staging | Locally advanced breast cancer | Secondary malignant neoplasm of lymph node Supraclavicular Ipsilateral | TNM clinical staging | Fine needle aspiration of axillary lymph node | AXILLARY LYMPH NODE METASTASIS Diameter Sentinel Lymph Node Biopsy | Neoplasm Diameter | Breast-Conserving Surgery Unsuccessful
Item
stage ii or stage iii breast cancer.28 'locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. n1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of >2 mm in diameter at sentinel node biopsy. stage iia patients are eligible if the tumor is >3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
boolean
C0678222 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2])
C0686619 (UMLS CUI [3,1])
C0229730 (UMLS CUI [3,2])
C0441989 (UMLS CUI [3,3])
C3258246 (UMLS CUI [4])
C0398445 (UMLS CUI [5])
C0741344 (UMLS CUI [6,1])
C1301886 (UMLS CUI [6,2])
C0796693 (UMLS CUI [6,3])
C0027651 (UMLS CUI [7,1])
C1301886 (UMLS CUI [7,2])
C0917927 (UMLS CUI [8,1])
C1272705 (UMLS CUI [8,2])
HER2 Overexpression | HER2 gene amplification | Invasive Carcinoma Component Core 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])
C1334274 (UMLS CUI [3,1])
C1705248 (UMLS CUI [3,2])
C1318309 (UMLS CUI [3,3])
Invasive Carcinoma Cells Percentage | Membrane Staining Strong | Score Positive
Item
>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
boolean
C1334274 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C3161472 (UMLS CUI [2,1])
C1704680 (UMLS CUI [2,2])
C0442821 (UMLS CUI [2,3])
C0449820 (UMLS CUI [3,1])
C1514241 (UMLS CUI [3,2])
Invasive Carcinoma Cells Percentage | Membrane Staining Moderate | Score Moderate | HER2 gene amplification | HER2/CEP17 Ratio FISH | CISH
Item
>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating her2 gene amplification defined as a fish ratio of her2 gene copies to chromosome 17 signals of >2.2. or as >5 her2 gene copies per nucleus in cish analysis.
boolean
C1334274 (UMLS CUI [1,1])
C0007634 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C3161472 (UMLS CUI [2,1])
C1704680 (UMLS CUI [2,2])
C0205081 (UMLS CUI [2,3])
C0449820 (UMLS CUI [3,1])
C0205081 (UMLS CUI [3,2])
C1512127 (UMLS CUI [4])
C1977461 (UMLS CUI [5])
C1516514 (UMLS CUI [6])
Test result Negative Ineligible | Test result Equivocal Ineligible | HER2/CEP17 Ratio FISH | CISH | Staining Score Immunohistochemistry | Neoplastic Cells Percentage
Item
patients with a negative or equivocal overall result (fish test ratio of <2.2, <6.0 her2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by ihc are not eligible for participation in the trial.
boolean
C0587081 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
C1512714 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C0332241 (UMLS CUI [2,2])
C1512714 (UMLS CUI [2,3])
C1977461 (UMLS CUI [3])
C1516514 (UMLS CUI [4])
C1704680 (UMLS CUI [5,1])
C0449820 (UMLS CUI [5,2])
C0021044 (UMLS CUI [5,3])
C0597032 (UMLS CUI [6,1])
C0439165 (UMLS CUI [6,2])
Age
Item
age ≥18
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤1 (appendix b)
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement
Item
adequate bone marrow function (anc >1.0 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 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 clearance measurement
Item
adequate renal function (creatinine clearance >60 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning
Item
lvef ≥50% measured by echocardiography or muga
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
Condition Preventing Protocol Compliance
Item
absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Informed Consent
Item
signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Therapeutic radiology procedure | Chemotherapy
Item
no previous radiation therapy or chemotherapy
boolean
C1522449 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
Cancer Other | Exception Carcinoma in Situ | Exception Curative treatment Other Cancer
Item
no other malignancy except carcinoma in situ, unless the other malignancy was treated
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])
Chemotherapy Absent | Therapeutic radiology procedure Absent
Item
≥5 years ago with curative intent without the use of chemotherapy or radiation therapy.
boolean
C0392920 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
Item
no 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 | TNM Breast tumor staging | Plain chest X-ray | Liver Ultrasonography | Radioisotope scan of bone | Secondary malignant neoplasm of bone Absent | MRI | CT scan
Item
no evidence of distant metastases. staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. abnormal uptake on the isotope bone scan can only be accepted if mri, ct-scan, or plain radiograph excludes bone metastases.
boolean
C1269798 (UMLS CUI [1])
C0474926 (UMLS CUI [2])
C0039985 (UMLS CUI [3])
C0023884 (UMLS CUI [4,1])
C0041618 (UMLS CUI [4,2])
C0203668 (UMLS CUI [5])
C0153690 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0024485 (UMLS CUI [7])
C0040405 (UMLS CUI [8])
Cancer treatment | Investigational New Drugs
Item
no concurrent anti-cancer treatment or another investigational drug
boolean
C0920425 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
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