ID

15503

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02252887

Stichworte

Versionen (1)
  1. 01.06.16 01.06.16 -
Hochgeladen am

1. Juni 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

Englisch

Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥ to 18
Beschreibung

Age

Datentyp

boolean

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

HER2-positive carcinoma of breast | Tumor Stage Classification

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Measurable Disease

Datentyp

boolean

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

LVEF

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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
Beschreibung

Creatinine measurement, serum

Datentyp

boolean

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

Lesion of brain Treated Stable status

Datentyp

boolean

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

Exclusion Criteria

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

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

Datentyp

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
Beschreibung

Hypersensitivity trastuzumab | Hypersensitivity pertuzumab | Toxicity trastuzumab | Toxicity pertuzumab

Datentyp

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
Beschreibung

Peripheral Neuropathy

Datentyp

boolean

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

Hepatitis B | Hepatitis C

Datentyp

boolean

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

Pregnancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video