ID

24611

Beschrijving

A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00509769

Link

https://clinicaltrials.gov/show/NCT00509769

Trefwoorden

Versies (1)
  1. 08-08-17 08-08-17 -
Geüploaded op

8 augustus 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00509769

Engels

Eligibility Metastatic Breast Cancer NCT00509769

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
signed informed consent form.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer (mbc); tissue (slides or blocks) available for her2 confirmation.
Beschrijving

Secondary malignant neoplasm of female breast HER2/Neu Positive | Tissue specimen Available

Datatype

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C2348909
UMLS CUI [2,1]
C1292533
UMLS CUI [2,2]
C0470187
history of progression on her2-directed therapy for the treatment of her2-positive breast cancer.
Beschrijving

Therapeutic procedure HER2 Targeted HER2-positive carcinoma of breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0069515
UMLS CUI [1,3]
C1521840
UMLS CUI [1,4]
C1960398
at least 1, and no more than 3, chemotherapy regimens for mbc.
Beschrijving

Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0346993
granulocyte count ≥ 1500/μl, platelet count ≥ 100,000/μl, and hemoglobin ≥ 9 g/dl.
Beschrijving

Granulocyte count | Platelet Count measurement | Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0857490
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
serum bilirubin ≤ 1.5 mg/dl, aspartate aminotransferase (ast), alanine aminotransferase (alt), and alkaline phosphatase ≤ 2.5x the upper limit of normal (uln).
Beschrijving

Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min.
Beschrijving

Creatinine measurement, serum | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.
Beschrijving

Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma | Immunotherapy Breast Carcinoma | Biological treatment Breast Carcinoma

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C0021083
UMLS CUI [4,2]
C0678222
UMLS CUI [5,1]
C1531518
UMLS CUI [5,2]
C0678222
prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent.
Beschrijving

Doxorubicin Cumulative Dose

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
history of significant cardiac disease, unstable angina, congestive heart failure (chf), myocardial infarction, or ventricular arrythmia requiring medication.
Beschrijving

Heart Diseases | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia Requirement Pharmaceutical Preparations

Datatype

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0018802
UMLS CUI [4]
C0027051
UMLS CUI [5,1]
C0085612
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0013227
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Similar models

Eligibility Metastatic Breast Cancer NCT00509769

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
signed informed consent form.
boolean
C0021430 (UMLS CUI [1])
Secondary malignant neoplasm of female breast HER2/Neu Positive | Tissue specimen Available
Item
human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer (mbc); tissue (slides or blocks) available for her2 confirmation.
boolean
C0346993 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1292533 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
Therapeutic procedure HER2 Targeted HER2-positive carcinoma of breast
Item
history of progression on her2-directed therapy for the treatment of her2-positive breast cancer.
boolean
C0087111 (UMLS CUI [1,1])
C0069515 (UMLS CUI [1,2])
C1521840 (UMLS CUI [1,3])
C1960398 (UMLS CUI [1,4])
Chemotherapy Regimen Quantity Secondary malignant neoplasm of female breast
Item
at least 1, and no more than 3, chemotherapy regimens for mbc.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Granulocyte count | Platelet Count measurement | Hemoglobin measurement
Item
granulocyte count ≥ 1500/μl, platelet count ≥ 100,000/μl, and hemoglobin ≥ 9 g/dl.
boolean
C0857490 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
serum bilirubin ≤ 1.5 mg/dl, aspartate aminotransferase (ast), alanine aminotransferase (alt), and alkaline phosphatase ≤ 2.5x the upper limit of normal (uln).
boolean
C1278039 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Breast Carcinoma | Hormone Therapy Breast Carcinoma | Therapeutic radiology procedure Breast Carcinoma | Immunotherapy Breast Carcinoma | Biological treatment Breast Carcinoma
Item
any chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or biological therapy for the treatment of breast cancer within 2 weeks of the first study treatment.
boolean
C0392920 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1522449 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0021083 (UMLS CUI [4,1])
C0678222 (UMLS CUI [4,2])
C1531518 (UMLS CUI [5,1])
C0678222 (UMLS CUI [5,2])
Doxorubicin Cumulative Dose
Item
prior cumulative doxorubicin dose > 360 mg/m^2 or the equivalent.
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
Heart Diseases | Angina, Unstable | Congestive heart failure | Myocardial Infarction | Ventricular arrhythmia Requirement Pharmaceutical Preparations
Item
history of significant cardiac disease, unstable angina, congestive heart failure (chf), myocardial infarction, or ventricular arrythmia requiring medication.
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0027051 (UMLS CUI [4])
C0085612 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0013227 (UMLS CUI [5,3])
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