ID

38000

Beskrivning

A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT01419197

Länk

https://clinicaltrials.gov/show/NCT01419197

Nyckelord

Versioner (1)
  1. 2019-09-06 2019-09-06 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

6 september 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Breast Cancer NCT01419197

Engelsk

Eligibility Breast Cancer NCT01419197

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients ≥ 18 years of age.
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically or cytologically documented breast cancer.
Beskrivning

Breast Carcinoma

Datatyp

boolean

Alias
UMLS CUI [1]
C0678222
metastatic or unresectable locally advanced/recurrent breast cancer.
Beskrivning

Secondary malignant neoplasm of female breast | Locally advanced breast cancer unresectable | Breast cancer recurrent unresectable

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2,1]
C3495949
UMLS CUI [2,2]
C1519810
UMLS CUI [3,1]
C0278493
UMLS CUI [3,2]
C1519810
her2-positive disease by prospective laboratory confirmation.
Beskrivning

Disease HER2 Positive Laboratory Procedure

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C0022885
disease progression on the last regimen received as defined by the investigator.
Beskrivning

Disease Progression | Status post Treatment Last

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0087111
UMLS CUI [2,3]
C1517741
prior treatment with an trastuzumab, a taxane, and lapatinib.
Beskrivning

Prior Therapy | trastuzumab | taxane | lapatinib

Datatyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0728747
UMLS CUI [3]
C0215136
UMLS CUI [4]
C1506770
disease progression after at least two regimens of her2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
Beskrivning

Disease Progression | Status post HER2 Targeted Therapy Quantity | Neoplasm Metastasis | Advanced disease Locally unresectable | Recurrent disease unresectable

Datatyp

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0069515
UMLS CUI [2,3]
C2985566
UMLS CUI [2,4]
C1265611
UMLS CUI [3]
C0027627
UMLS CUI [4,1]
C0679246
UMLS CUI [4,2]
C1517927
UMLS CUI [4,3]
C1519810
UMLS CUI [5,1]
C0277556
UMLS CUI [5,2]
C1519810
adequate organ function, as evidenced by laboratory results.
Beskrivning

Organ function Laboratory Results

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C1254595
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction (lvef) ≥ 50% by echocardiogram or multi gated acquisition scan.
Beskrivning

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
chemotherapy ≤ 21 days before first study treatment.
Beskrivning

Chemotherapy Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0332185
trastuzumab ≤ 21 days before first study treatment.
Beskrivning

Trastuzumab Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0332185
lapatinib ≤ 14 days before first study treatment.
Beskrivning

Lapatinib Recently

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1506770
UMLS CUI [1,2]
C0332185
prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.
Beskrivning

Study Subject Participation Status | Clinical Trial Containing Trastuzumab emtansine

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C2935436
brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
Beskrivning

Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Requirement Therapeutic radiology procedure | Metastatic malignant neoplasm to brain Requirement Operative Surgical Procedures | Metastatic malignant neoplasm to brain Requirement Steroid therapy | Symptom control

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0332155
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C1522449
UMLS CUI [4,1]
C0220650
UMLS CUI [4,2]
C1514873
UMLS CUI [4,3]
C0543467
UMLS CUI [5,1]
C0220650
UMLS CUI [5,2]
C1514873
UMLS CUI [5,3]
C0149783
UMLS CUI [6]
C1274136
Tillbaka till toppen

Similar models

Eligibility Breast Cancer NCT01419197

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients ≥ 18 years of age.
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma
Item
histologically or cytologically documented breast cancer.
boolean
C0678222 (UMLS CUI [1])
Secondary malignant neoplasm of female breast | Locally advanced breast cancer unresectable | Breast cancer recurrent unresectable
Item
metastatic or unresectable locally advanced/recurrent breast cancer.
boolean
C0346993 (UMLS CUI [1])
C3495949 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0278493 (UMLS CUI [3,1])
C1519810 (UMLS CUI [3,2])
Disease HER2 Positive Laboratory Procedure
Item
her2-positive disease by prospective laboratory confirmation.
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0022885 (UMLS CUI [1,3])
Disease Progression | Status post Treatment Last
Item
disease progression on the last regimen received as defined by the investigator.
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C1517741 (UMLS CUI [2,3])
Prior Therapy | trastuzumab | taxane | lapatinib
Item
prior treatment with an trastuzumab, a taxane, and lapatinib.
boolean
C1514463 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C0215136 (UMLS CUI [3])
C1506770 (UMLS CUI [4])
Disease Progression | Status post HER2 Targeted Therapy Quantity | Neoplasm Metastasis | Advanced disease Locally unresectable | Recurrent disease unresectable
Item
disease progression after at least two regimens of her2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0069515 (UMLS CUI [2,2])
C2985566 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
C0027627 (UMLS CUI [3])
C0679246 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
C1519810 (UMLS CUI [4,3])
C0277556 (UMLS CUI [5,1])
C1519810 (UMLS CUI [5,2])
Organ function Laboratory Results
Item
adequate organ function, as evidenced by laboratory results.
boolean
C0678852 (UMLS CUI [1,1])
C1254595 (UMLS CUI [1,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0, 1, or 2.
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
left ventricular ejection fraction (lvef) ≥ 50% by echocardiogram or multi gated acquisition scan.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Chemotherapy Recently
Item
chemotherapy ≤ 21 days before first study treatment.
boolean
C0392920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Trastuzumab Recently
Item
trastuzumab ≤ 21 days before first study treatment.
boolean
C0728747 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Lapatinib Recently
Item
lapatinib ≤ 14 days before first study treatment.
boolean
C1506770 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Containing Trastuzumab emtansine
Item
prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C2935436 (UMLS CUI [2,3])
Metastatic malignant neoplasm to brain Untreated | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Requirement Therapeutic radiology procedure | Metastatic malignant neoplasm to brain Requirement Operative Surgical Procedures | Metastatic malignant neoplasm to brain Requirement Steroid therapy | Symptom control
Item
brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0220650 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C1522449 (UMLS CUI [3,3])
C0220650 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0543467 (UMLS CUI [4,3])
C0220650 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0149783 (UMLS CUI [5,3])
C1274136 (UMLS CUI [6])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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