ID

30601

Beskrivning

Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression; ODM derived from: https://clinicaltrials.gov/show/NCT00943670

Länk

https://clinicaltrials.gov/show/NCT00943670

Nyckelord

Versioner (1)
  1. 2018-06-17 2018-06-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 juni 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT00943670

Engelsk

Eligibility Metastatic Breast Cancer NCT00943670

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted
Beskrivning

Locally advanced breast cancer | Secondary malignant neoplasm of female breast | Measurable Disease | Non-Measurable Lesion | Evaluable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C3495949
UMLS CUI [2]
C0346993
UMLS CUI [3]
C1513041
UMLS CUI [4]
C1334988
UMLS CUI [5]
C1516986
her2-positive disease
Beskrivning

Disease HER2 Positive

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
history of prior trastuzumab therapy
Beskrivning

Trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0728747
life expectancy ≥ 90 days as assessed by the investigator
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
negative urine pregnancy test ≤ 72 hours prior to cycle 1 day 1 for all women of childbearing potential
Beskrivning

Childbearing Potential Urine pregnancy test negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
for patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of t-dm1 or 6 months after the last dose of pertuzumab, if applicable
Beskrivning

Childbearing Potential Contraceptive methods Quantity | T-DM1 | Pertuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C1265611
UMLS CUI [2]
C2935436
UMLS CUI [3]
C1328025
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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 t-dm1 or pertuzumab therapy
Beskrivning

T-DM1 | Pertuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C2935436
UMLS CUI [2]
C1328025
history of intolerance (such as grade 3-4 infusion reaction) and/or adverse events related to trastuzumab
Beskrivning

Intolerance to Trastuzumab | Infusion reaction Trastuzumab CTCAE Grades | Adverse event Trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1744706
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C2368034
UMLS CUI [2,2]
C0728747
UMLS CUI [2,3]
C1516728
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0728747
grade ≥ 2 (based on national cancer institute common terminology criteria for adverse events [nci ctcae] v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to the first study treatment
Beskrivning

Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for | Therapeutic radiology procedure | Operative Surgical Procedures | Steroids | Symptom control Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0205329
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0332121
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0543467
UMLS CUI [6]
C0038317
UMLS CUI [7,1]
C1274136
UMLS CUI [7,2]
C0220650
history of cardiac disease, unstable angina, symptomatic congestive heart failure (chf) (class ≥ ii per the new york heart associate [nyha] guidelines), myocardial infarction, or ventricular arrhythmia ≤ 6 months prior to cycle 1, day 1
Beskrivning

Heart Diseases | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Myocardial Infarction | Ventricular arrhythmia

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0742758
UMLS CUI [4]
C1275491
UMLS CUI [5]
C0027051
UMLS CUI [6]
C0085612
implantable pacemaker or automatic implantable cardioverter defibrillator
Beskrivning

Artificial cardiac pacemaker | Automatic Implantable Cardioverter-Defibrillators

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0972395
congenital long qt syndrome or family history of long qt syndrome
Beskrivning

Congenital long QT syndrome | Family history of long QT syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C1141890
UMLS CUI [2]
C3839836
current uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (tdp)
Beskrivning

Pharmaceutical Preparations Changing Cardiac conduction | Digitalis preparation | Adrenergic beta-Antagonists | Calcium Channel Blockers | Pharmaceutical Preparations Causing Torsades de Pointes

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0232217
UMLS CUI [2]
C0304520
UMLS CUI [3]
C0001645
UMLS CUI [4]
C0006684
UMLS CUI [5,1]
C0013227
UMLS CUI [5,2]
C0678227
UMLS CUI [5,3]
C0040479
current known active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus
Beskrivning

HIV Infection | Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment
Beskrivning

Major surgery | Traumatic injury | Patient need for Major surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C3263723
UMLS CUI [3,1]
C0686904
UMLS CUI [3,2]
C0679637
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Similar models

Eligibility Metastatic Breast Cancer NCT00943670

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Locally advanced breast cancer | Secondary malignant neoplasm of female breast | Measurable Disease | Non-Measurable Lesion | Evaluable Disease
Item
histologically documented, locally advanced, or metastatic breast cancer; measurable and/or non-measureable but evaluable disease is permitted
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C1513041 (UMLS CUI [3])
C1334988 (UMLS CUI [4])
C1516986 (UMLS CUI [5])
Disease HER2 Positive
Item
her2-positive disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Trastuzumab
Item
history of prior trastuzumab therapy
boolean
C0728747 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 90 days as assessed by the investigator
boolean
C0023671 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative
Item
negative urine pregnancy test ≤ 72 hours prior to cycle 1 day 1 for all women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Quantity | T-DM1 | Pertuzumab
Item
for patients of childbearing potential, agreement to use one highly effective form of contraception or two effective forms of contraception for the duration of the study treatment(s) and for 4 months after the last dose of t-dm1 or 6 months after the last dose of pertuzumab, if applicable
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2935436 (UMLS CUI [2])
C1328025 (UMLS CUI [3])
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 biologic 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])
T-DM1 | Pertuzumab
Item
prior t-dm1 or pertuzumab therapy
boolean
C2935436 (UMLS CUI [1])
C1328025 (UMLS CUI [2])
Intolerance to Trastuzumab | Infusion reaction Trastuzumab CTCAE Grades | Adverse event Trastuzumab
Item
history of intolerance (such as grade 3-4 infusion reaction) and/or adverse events related to trastuzumab
boolean
C1744706 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C2368034 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C1516728 (UMLS CUI [2,3])
C0877248 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
Peripheral Neuropathy CTCAE Grades
Item
grade ≥ 2 (based on national cancer institute common terminology criteria for adverse events [nci ctcae] v3) peripheral neuropathy at the time of or within 3 weeks prior to the first study treatment
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Progressive | Metastatic malignant neoplasm to brain Treatment required for | Therapeutic radiology procedure | Operative Surgical Procedures | Steroids | Symptom control Metastatic malignant neoplasm to brain
Item
brain metastases that are untreated or progressive or have required any type of therapy, including radiation, surgery, and/or steroids, to control symptoms from brain metastases within 60 days prior to the first study treatment
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0205329 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C1522449 (UMLS CUI [4])
C0543467 (UMLS CUI [5])
C0038317 (UMLS CUI [6])
C1274136 (UMLS CUI [7,1])
C0220650 (UMLS CUI [7,2])
Heart Diseases | Angina, Unstable | Symptomatic congestive heart failure New York Heart Association Classification | Myocardial Infarction | Ventricular arrhythmia
Item
history of cardiac disease, unstable angina, symptomatic congestive heart failure (chf) (class ≥ ii per the new york heart associate [nyha] guidelines), myocardial infarction, or ventricular arrhythmia ≤ 6 months prior to cycle 1, day 1
boolean
C0018799 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C0027051 (UMLS CUI [5])
C0085612 (UMLS CUI [6])
Artificial cardiac pacemaker | Automatic Implantable Cardioverter-Defibrillators
Item
implantable pacemaker or automatic implantable cardioverter defibrillator
boolean
C0030163 (UMLS CUI [1])
C0972395 (UMLS CUI [2])
Congenital long QT syndrome | Family history of long QT syndrome
Item
congenital long qt syndrome or family history of long qt syndrome
boolean
C1141890 (UMLS CUI [1])
C3839836 (UMLS CUI [2])
Uncontrolled hypertension
Item
current uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Pharmaceutical Preparations Changing Cardiac conduction | Digitalis preparation | Adrenergic beta-Antagonists | Calcium Channel Blockers | Pharmaceutical Preparations Causing Torsades de Pointes
Item
current treatment with medications that alter cardiac conduction (e.g., digitalis, beta-blockers, or calcium channel blockers) or medications that are generally accepted to have a risk of causing torsades de pointes (tdp)
boolean
C0013227 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0232217 (UMLS CUI [1,3])
C0304520 (UMLS CUI [2])
C0001645 (UMLS CUI [3])
C0006684 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0678227 (UMLS CUI [5,2])
C0040479 (UMLS CUI [5,3])
HIV Infection | Hepatitis B | Hepatitis C
Item
current known active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Major surgery | Traumatic injury | Patient need for Major surgery
Item
major surgical procedure or significant traumatic injury within 28 days prior to first study treatment, or anticipation of the need for major surgery during the course of study treatment
boolean
C0679637 (UMLS CUI [1])
C3263723 (UMLS CUI [2])
C0686904 (UMLS CUI [3,1])
C0679637 (UMLS CUI [3,2])
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