ID

38057

Beskrivning

A Study of Pertuzumab in Combination With Herceptin (Trastuzumab) and A Taxane in First-Line Treatment in Patients With HER2-Positive Advanced Breast Cancer (PERUSE); ODM derived from: https://clinicaltrials.gov/show/NCT01572038

Länk

https://clinicaltrials.gov/show/NCT01572038

Nyckelord

Versioner (1)
  1. 2019-09-12 2019-09-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 september 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01572038

Engelsk

Eligibility Breast Cancer NCT01572038

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult male or female patients, >/= 18 years of age
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
Beskrivning

Breast adenocarcinoma | Neoplasm Metastasis | Recurrent disease Locally | Disease Inappropriate Excision Curative

Datatyp

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2]
C0027627
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C1517927
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C0728940
UMLS CUI [4,4]
C1276305
her2-positive breast cancer
Beskrivning

HER2-positive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C1960398
eastern cooperative oncology group (ecog) performance status 0, 1 or 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction (lvef) of at least 50%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
Beskrivning

Cancer treatment Systemic Neoplasm Metastasis | Cancer treatment Systemic Recurrent disease Locally | Exception Hormone Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C0277556
UMLS CUI [2,4]
C1517927
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0279025
disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence </= 6 months
Beskrivning

Interval Disease Free | Completion Adjuvant therapy Systemic | Completion Neoadjuvant Therapy Systemic | Exception Hormone Therapy | Recurrence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C0012634
UMLS CUI [1,3]
C0332296
UMLS CUI [2,1]
C0205197
UMLS CUI [2,2]
C0677850
UMLS CUI [2,3]
C0205373
UMLS CUI [3,1]
C0205197
UMLS CUI [3,2]
C0600558
UMLS CUI [3,3]
C0205373
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0279025
UMLS CUI [5]
C0034897
previous approved or investigative anti-her2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Beskrivning

HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational | Therapeutic procedure Breast Carcinoma | Exception Trastuzumab Adjuvant therapy | Exception Lapatinib Adjuvant therapy | Exception Trastuzumab Neoadjuvant Therapy | Exception Lapatinib Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C2267079
UMLS CUI [2,1]
C2267079
UMLS CUI [2,2]
C1517586
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0678222
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0728747
UMLS CUI [4,3]
C0677850
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1506770
UMLS CUI [5,3]
C0677850
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0728747
UMLS CUI [6,3]
C0600558
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C1506770
UMLS CUI [7,3]
C0600558
disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
Beskrivning

Disease Progression | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C1506770
UMLS CUI [3,2]
C0677850
UMLS CUI [4,1]
C0728747
UMLS CUI [4,2]
C0600558
UMLS CUI [5,1]
C1506770
UMLS CUI [5,2]
C0600558
history of persistent grade 2 or higher (nci-ctc, version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
Beskrivning

Toxicity Hematological Persistent CTCAE Grades | Etiology Adjuvant therapy | Etiology Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205488
UMLS CUI [1,3]
C0205322
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0600558
central nervous system (cns) metastases
Beskrivning

CNS metastases

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
current peripheral neuropathy of grade 3 or greater (nci-ctc, version 4.0)
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
history of other malignancy within the last 5 years prior to 1st study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
Beskrivning

Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
inadequate bone marrow, liver or renal function
Beskrivning

Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205412
uncontrolled hypertension
Beskrivning

Uncontrolled hypertension

Datatyp

boolean

Alias
UMLS CUI [1]
C1868885
hepatitis b, hepatitis c or hiv infection
Beskrivning

Hepatitis B | Hepatitis C | HIV Infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
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Similar models

Eligibility Breast Cancer NCT01572038

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult male or female patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast adenocarcinoma | Neoplasm Metastasis | Recurrent disease Locally | Disease Inappropriate Excision Curative
Item
histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection
boolean
C0858252 (UMLS CUI [1])
C0027627 (UMLS CUI [2])
C0277556 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0012634 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0728940 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
HER2-positive carcinoma of breast
Item
her2-positive breast cancer
boolean
C1960398 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) of at least 50%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment Systemic Neoplasm Metastasis | Cancer treatment Systemic Recurrent disease Locally | Exception Hormone Therapy
Item
previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0277556 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0279025 (UMLS CUI [3,2])
Interval Disease Free | Completion Adjuvant therapy Systemic | Completion Neoadjuvant Therapy Systemic | Exception Hormone Therapy | Recurrence
Item
disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence </= 6 months
boolean
C1272706 (UMLS CUI [1,1])
C0012634 (UMLS CUI [1,2])
C0332296 (UMLS CUI [1,3])
C0205197 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0205373 (UMLS CUI [2,3])
C0205197 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0205373 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0279025 (UMLS CUI [4,2])
C0034897 (UMLS CUI [5])
HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational | Therapeutic procedure Breast Carcinoma | Exception Trastuzumab Adjuvant therapy | Exception Lapatinib Adjuvant therapy | Exception Trastuzumab Neoadjuvant Therapy | Exception Lapatinib Neoadjuvant Therapy
Item
previous approved or investigative anti-her2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
boolean
C2267079 (UMLS CUI [1])
C2267079 (UMLS CUI [2,1])
C1517586 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C0677850 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1506770 (UMLS CUI [5,2])
C0677850 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
C0600558 (UMLS CUI [6,3])
C1705847 (UMLS CUI [7,1])
C1506770 (UMLS CUI [7,2])
C0600558 (UMLS CUI [7,3])
Disease Progression | Trastuzumab Adjuvant therapy | Lapatinib Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Lapatinib Neoadjuvant Therapy
Item
disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
boolean
C0242656 (UMLS CUI [1])
C0728747 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C1506770 (UMLS CUI [3,1])
C0677850 (UMLS CUI [3,2])
C0728747 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C1506770 (UMLS CUI [5,1])
C0600558 (UMLS CUI [5,2])
Toxicity Hematological Persistent CTCAE Grades | Etiology Adjuvant therapy | Etiology Neoadjuvant Therapy
Item
history of persistent grade 2 or higher (nci-ctc, version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
boolean
C0600688 (UMLS CUI [1,1])
C0205488 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0015127 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
CNS metastases
Item
central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
current peripheral neuropathy of grade 3 or greater (nci-ctc, version 4.0)
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Cancer Other | Exception Carcinoma in situ of uterine cervix | Exception Basal cell carcinoma
Item
history of other malignancy within the last 5 years prior to 1st study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, liver or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Hepatitis B | Hepatitis C | HIV Infection
Item
hepatitis b, hepatitis c or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
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