ID

15503

Beskrivning

Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02252887

Länk

https://clinicaltrials.gov/show/NCT02252887

Nyckelord

Versioner (1)
  1. 2016-06-01 2016-06-01 -
Uppladdad den

1 juni 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

Engelsk

Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ to 18
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
stage iv her2 (+) breast cancer
Beskrivning

HER2-positive carcinoma of breast | Tumor Stage Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C0178759
histologically documented her2 (+) breast cancer as defined as ihc 3+ or fish amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable.
Beskrivning

HER2-positive carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization | Primary tumor site | Site, metastatic cancer

Datatyp

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2]
C0021044
UMLS CUI [3]
C0162789
UMLS CUI [4]
C0475447
UMLS CUI [5]
C0280457
lecog performance status 0 -1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
prior treatment with trastuzumab + pertuzumab (hp)-based therapy or pertuzumab-based in the neoadjuvantadjuvant, unresectable, locally advanced, or metastatic setting.
Beskrivning

Prior Therapy | trastuzumab | pertuzumab | Neoadjuvant Therapy | unresectable | Locally advanced breast cancer | metastatic

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0728747
UMLS CUI [3]
C1328025
UMLS CUI [4]
C0600558
UMLS CUI [5]
C1519810
UMLS CUI [6]
C3495949
UMLS CUI [7]
C1522484
≤ 3 prior chemotherapies in the metastatic setting. prior anthracycline, taxane, gemcitabine, and anti-her2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib, tdm-1, etc.) are allowed. if patients received prior gemcitabine, it could not have been combined with pertuzumab. patients should have progression of disease on current therapy.
Beskrivning

Prior Chemotherapy | metastatic | Anthracyclines | taxane | gemcitabine | trastuzumab | pertuzumab | lapatinib | neratinib | T-DM1 | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C1514457
UMLS CUI [2]
C1522484
UMLS CUI [3]
C0282564
UMLS CUI [4]
C0215136
UMLS CUI [5]
C0045093
UMLS CUI [6]
C0728747
UMLS CUI [7]
C1328025
UMLS CUI [8]
C1506770
UMLS CUI [9]
C2713008
UMLS CUI [10]
C2935436
UMLS CUI [11]
C0242656
measurable or non-measurable disease.
Beskrivning

Measurable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
lvef ≥ 50%
Beskrivning

LVEF

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
hematologic parameters: white blood cell (wbc) count of ≥ 3000/ul, absolute neutrophil count (anc) ≥ 1000/ul, platelets ≥ 100,000/ul, hemoglobin ≥10.0 g/dl
Beskrivning

Parameters Hematologic | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449381
UMLS CUI [1,2]
C0205488
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0948762
UMLS CUI [4]
C0032181
UMLS CUI [5]
C0019046
non-hematologic parameters: bilirubin ≤ 1.5 mg/dl, ast/alt≤ 2.5 x upper limit of normal (uln), alkaline phosphatase ≤ 5 x uln.
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0449381
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0201850
creatinine ≤ 1.5 mg/dl
Beskrivning

Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled.
Beskrivning

Lesion of brain Treated Stable status

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221505
UMLS CUI [1,2]
C1522326
UMLS CUI [1,3]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of prior unstable angina, myocardial infarction, chf, uncontrolled ventricular arrhythmias within 12 months
Beskrivning

Angina, Unstable | Myocardial Infarction | Congestive heart failure | Ventricular arrhythmia Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0085612
UMLS CUI [4,2]
C0205318
history of prior ≥ g 3 hypersensitivity (hsr) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
Beskrivning

Hypersensitivity trastuzumab | Hypersensitivity pertuzumab | Toxicity trastuzumab | Toxicity pertuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1328025
UMLS CUI [3,1]
C0040539
UMLS CUI [3,2]
C0728747
UMLS CUI [4,1]
C0040539
UMLS CUI [4,2]
C1328025
≥ to g 2 peripheral neuropathy
Beskrivning

Peripheral Neuropathy

Datatyp

boolean

Alias
UMLS CUI [1]
C0031117
history of hepatitis b or c
Beskrivning

Hepatitis B | Hepatitis C

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
pregnant patients
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥ to 18
boolean
C0001779 (UMLS CUI [1])
HER2-positive carcinoma of breast | Tumor Stage Classification
Item
stage iv her2 (+) breast cancer
boolean
C1960398 (UMLS CUI [1])
C0178759 (UMLS CUI [2])
HER2-positive carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization | Primary tumor site | Site, metastatic cancer
Item
histologically documented her2 (+) breast cancer as defined as ihc 3+ or fish amplification of ≥ 2.0 of primary or metastatic site; results from the local lab are acceptable.
boolean
C1960398 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
C0475447 (UMLS CUI [4])
C0280457 (UMLS CUI [5])
ECOG performance status
Item
lecog performance status 0 -1
boolean
C1520224 (UMLS CUI [1])
Prior Therapy | trastuzumab | pertuzumab | Neoadjuvant Therapy | unresectable | Locally advanced breast cancer | metastatic
Item
prior treatment with trastuzumab + pertuzumab (hp)-based therapy or pertuzumab-based in the neoadjuvantadjuvant, unresectable, locally advanced, or metastatic setting.
boolean
C1514463 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C1328025 (UMLS CUI [3])
C0600558 (UMLS CUI [4])
C1519810 (UMLS CUI [5])
C3495949 (UMLS CUI [6])
C1522484 (UMLS CUI [7])
Prior Chemotherapy | metastatic | Anthracyclines | taxane | gemcitabine | trastuzumab | pertuzumab | lapatinib | neratinib | T-DM1 | Disease Progression
Item
≤ 3 prior chemotherapies in the metastatic setting. prior anthracycline, taxane, gemcitabine, and anti-her2 agents (i.e. trastuzumab, pertuzumab, lapatinib, neratinib, tdm-1, etc.) are allowed. if patients received prior gemcitabine, it could not have been combined with pertuzumab. patients should have progression of disease on current therapy.
boolean
C1514457 (UMLS CUI [1])
C1522484 (UMLS CUI [2])
C0282564 (UMLS CUI [3])
C0215136 (UMLS CUI [4])
C0045093 (UMLS CUI [5])
C0728747 (UMLS CUI [6])
C1328025 (UMLS CUI [7])
C1506770 (UMLS CUI [8])
C2713008 (UMLS CUI [9])
C2935436 (UMLS CUI [10])
C0242656 (UMLS CUI [11])
Measurable Disease
Item
measurable or non-measurable disease.
boolean
C1513041 (UMLS CUI [1])
LVEF
Item
lvef ≥ 50%
boolean
C0428772 (UMLS CUI [1])
Parameters Hematologic | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Hemoglobin
Item
hematologic parameters: white blood cell (wbc) count of ≥ 3000/ul, absolute neutrophil count (anc) ≥ 1000/ul, platelets ≥ 100,000/ul, hemoglobin ≥10.0 g/dl
boolean
C0449381 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0023508 (UMLS CUI [2])
C0948762 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0019046 (UMLS CUI [5])
Parameters | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement
Item
non-hematologic parameters: bilirubin ≤ 1.5 mg/dl, ast/alt≤ 2.5 x upper limit of normal (uln), alkaline phosphatase ≤ 5 x uln.
boolean
C0449381 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0201850 (UMLS CUI [5])
Creatinine measurement, serum
Item
creatinine ≤ 1.5 mg/dl
boolean
C0201976 (UMLS CUI [1])
Lesion of brain Treated Stable status
Item
patients with "treated and stable" brain lesions of a duration of ≥ 2 months may be enrolled.
boolean
C0221505 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Angina, Unstable | Myocardial Infarction | Congestive heart failure | Ventricular arrhythmia Uncontrolled
Item
history of prior unstable angina, myocardial infarction, chf, uncontrolled ventricular arrhythmias within 12 months
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0018802 (UMLS CUI [3])
C0085612 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
Hypersensitivity trastuzumab | Hypersensitivity pertuzumab | Toxicity trastuzumab | Toxicity pertuzumab
Item
history of prior ≥ g 3 hypersensitivity (hsr) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1328025 (UMLS CUI [2,2])
C0040539 (UMLS CUI [3,1])
C0728747 (UMLS CUI [3,2])
C0040539 (UMLS CUI [4,1])
C1328025 (UMLS CUI [4,2])
Peripheral Neuropathy
Item
≥ to g 2 peripheral neuropathy
boolean
C0031117 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
history of hepatitis b or c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Pregnancy
Item
pregnant patients
boolean
C0032961 (UMLS CUI [1])
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