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ID

15503

Description

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

Keywords

Versions (1)
  1. 6/1/16 6/1/16 -
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June 1, 2016

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License

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

    English

    Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age ≥ to 18
    Description

    Age

    Data type

    boolean

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

    HER2-positive carcinoma of breast | Tumor Stage Classification

    Data type

    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.
    Description

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

    Data type

    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
    Description

    ECOG performance status

    Data type

    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.
    Description

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

    Data type

    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.
    Description

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

    Data type

    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.
    Description

    Measurable Disease

    Data type

    boolean

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

    LVEF

    Data type

    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
    Description

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

    Data type

    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.
    Description

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

    Data type

    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
    Description

    Creatinine measurement, serum

    Data type

    boolean

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

    Lesion of brain Treated Stable status

    Data type

    boolean

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

    Exclusion Criteria

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

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

    Data type

    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
    Description

    Hypersensitivity trastuzumab | Hypersensitivity pertuzumab | Toxicity trastuzumab | Toxicity pertuzumab

    Data type

    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
    Description

    Peripheral Neuropathy

    Data type

    boolean

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

    Hepatitis B | Hepatitis C

    Data type

    boolean

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

    Pregnancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
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    Similar models

    Eligibility Metastatic HER2-Positive Breast Cancer NCT02252887

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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