ID

38057

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01572038

Trefwoorden

Versies (1)
  1. 12-09-19 12-09-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

12 september 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Breast Cancer NCT01572038

Engels

Eligibility Breast Cancer NCT01572038

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Adult | Age

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

HER2-positive carcinoma of breast

Datatype

boolean

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

ECOG performance status

Datatype

boolean

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

Left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

CNS metastases

Datatype

boolean

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

Peripheral Neuropathy CTCAE Grades

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Uncontrolled hypertension

Datatype

boolean

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

Hepatitis B | Hepatitis C | HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
Terug naar het begin van de pagina

Similar models

Eligibility Breast Cancer NCT01572038

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial