ID

34993

Beschreibung

MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT02213744

Link

https://clinicaltrials.gov/show/NCT02213744

Stichworte

Versionen (1)
  1. 07.02.19 07.02.19 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

7. Februar 2019

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02213744

Englisch

Eligibility Breast Cancer NCT02213744

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients must have histologically or cytologically confirmed invasive cancer of the breast
Beschreibung

Invasive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C0853879
patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent.
Beschreibung

Advanced disease Locally | Neoplasm Metastasis | Excision Curative intent Unsuccessful

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679246
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0728940
UMLS CUI [3,2]
C1276305
UMLS CUI [3,3]
C1272705
patients must have her2-positive breast cancer as defined by asco/cap 2013 guidelines that is confirmed by a sponsor-designated central laboratory
Beschreibung

HER2-positive carcinoma of breast

Datentyp

boolean

Alias
UMLS CUI [1]
C1960398
patients must have progressed on, or be intolerant to pertuzumab in the labc/mbc setting
Beschreibung

Disease Progression | Intolerance to Pertuzumab

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C1328025
patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the labc/mbc setting
Beschreibung

Disease Progression | Intolerance to Ado-trastuzumab emtansine

Datentyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C2935436
patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab)
Beschreibung

Trastuzumab Previous | Pertuzumab Previous

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C1328025
UMLS CUI [2,2]
C0205156
ecog performance status of 0 or 1
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative
Beschreibung

Doxorubicin | doxorubicin liposome | Epirubicin | Mitoxantrone | Anthracycline Derivative

Datentyp

boolean

Alias
UMLS CUI [1]
C0013089
UMLS CUI [2]
C0717726
UMLS CUI [3]
C0014582
UMLS CUI [4]
C0026259
UMLS CUI [5,1]
C0282564
UMLS CUI [5,2]
C1527240
subjects with central nervous system (cns) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment
Beschreibung

CNS metastases | Exception Treatment completed | Exception Stable status Without Symptoms | Exception Steroids Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0580352
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0205360
UMLS CUI [3,3]
C0332288
UMLS CUI [3,4]
C1457887
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0038317
UMLS CUI [4,3]
C0332197
patients with any class of new york heart association (nyha) chf or heart failure with preserved ejection fraction (hfpef)
Beschreibung

Congestive heart failure New York Heart Association Classification | Heart failure with preserved ejection fraction [HFpEF]

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
UMLS CUI [2]
C4509226
patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months
Beschreibung

Coronary Artery Disease | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0027051
patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
Beschreibung

Cardiac Arrhythmia Serious Treatment required for | Exception Controlled atrial fibrillation | Exception Paroxysmal supraventricular tachycardia

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0003811
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332121
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0577699
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0030590
patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
Beschreibung

Trastuzumab Discontinued Due to Cardiotoxicity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C0678226
UMLS CUI [1,4]
C0876994
patients with a history of lvef decline to below 50% during or after prior trastuzumab/lapatinib or other her2 directed therapy.
Beschreibung

Left ventricular ejection fraction | trastuzumab | lapatinib | HER2 Targeted Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0728747
UMLS CUI [3]
C1506770
UMLS CUI [4,1]
C0069515
UMLS CUI [4,2]
C2985566
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Ähnliche Modelle

Eligibility Breast Cancer NCT02213744

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Invasive carcinoma of breast
Item
patients must have histologically or cytologically confirmed invasive cancer of the breast
boolean
C0853879 (UMLS CUI [1])
Advanced disease Locally | Neoplasm Metastasis | Excision Curative intent Unsuccessful
Item
patients must have documented locally advanced/metastatic disease, defined by the investigator, which is not amenable to resection with curative intent.
boolean
C0679246 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2])
C0728940 (UMLS CUI [3,1])
C1276305 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
HER2-positive carcinoma of breast
Item
patients must have her2-positive breast cancer as defined by asco/cap 2013 guidelines that is confirmed by a sponsor-designated central laboratory
boolean
C1960398 (UMLS CUI [1])
Disease Progression | Intolerance to Pertuzumab
Item
patients must have progressed on, or be intolerant to pertuzumab in the labc/mbc setting
boolean
C0242656 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C1328025 (UMLS CUI [2,2])
Disease Progression | Intolerance to Ado-trastuzumab emtansine
Item
patients must have progressed on, or be intolerant to ado-trastuzumab emtansine in the labc/mbc setting
boolean
C0242656 (UMLS CUI [1])
C1744706 (UMLS CUI [2,1])
C2935436 (UMLS CUI [2,2])
Trastuzumab Previous | Pertuzumab Previous
Item
patients must have been previously treated with trastuzumab in any setting (which may have been previously administered with or without pertuzumab)
boolean
C0728747 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1328025 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Doxorubicin | doxorubicin liposome | Epirubicin | Mitoxantrone | Anthracycline Derivative
Item
patients who have previously been treated with doxorubicin, liposomal doxorubicin, epirubicin, mitoxantrone, or any other anthracycline derivative
boolean
C0013089 (UMLS CUI [1])
C0717726 (UMLS CUI [2])
C0014582 (UMLS CUI [3])
C0026259 (UMLS CUI [4])
C0282564 (UMLS CUI [5,1])
C1527240 (UMLS CUI [5,2])
CNS metastases | Exception Treatment completed | Exception Stable status Without Symptoms | Exception Steroids Absent
Item
subjects with central nervous system (cns) metastases, unless they have been treated and are stable without symptoms for 4 weeks after completion of treatment and must be off steroids for at least 4 weeks prior to enrollment
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0580352 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0332288 (UMLS CUI [3,3])
C1457887 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0038317 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
Congestive heart failure New York Heart Association Classification | Heart failure with preserved ejection fraction [HFpEF]
Item
patients with any class of new york heart association (nyha) chf or heart failure with preserved ejection fraction (hfpef)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C4509226 (UMLS CUI [2])
Coronary Artery Disease | Myocardial Infarction
Item
patients with a history of known coronary artery disease or a myocardial infarction within the last 12 months
boolean
C1956346 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Cardiac Arrhythmia Serious Treatment required for | Exception Controlled atrial fibrillation | Exception Paroxysmal supraventricular tachycardia
Item
patients with a known history of serious cardiac arrhythmias requiring treatment (exception: controlled atrial fibrillation, paroxysmal supraventricular tachycardia)
boolean
C0003811 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332121 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0577699 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0030590 (UMLS CUI [3,2])
Trastuzumab Discontinued Due to Cardiotoxicity
Item
patients who previously discontinued trastuzumab due to unacceptable cardiac toxicity
boolean
C0728747 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0678226 (UMLS CUI [1,3])
C0876994 (UMLS CUI [1,4])
Left ventricular ejection fraction | trastuzumab | lapatinib | HER2 Targeted Therapy
Item
patients with a history of lvef decline to below 50% during or after prior trastuzumab/lapatinib or other her2 directed therapy.
boolean
C0428772 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C1506770 (UMLS CUI [3])
C0069515 (UMLS CUI [4,1])
C2985566 (UMLS CUI [4,2])
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