ID

38000

Description

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

Link

https://clinicaltrials.gov/show/NCT01419197

Keywords

Versions (1)
  1. 9/6/19 9/6/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 6, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01419197

English

Eligibility Breast Cancer NCT01419197

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Age

Data type

boolean

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

Breast Carcinoma

Data type

boolean

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

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

Data type

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.
Description

Disease HER2 Positive Laboratory Procedure

Data type

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.
Description

Disease Progression | Status post Treatment Last

Data type

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.
Description

Prior Therapy | trastuzumab | taxane | lapatinib

Data type

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.
Description

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

Data type

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.
Description

Organ function Laboratory Results

Data type

boolean

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

ECOG performance status

Data type

boolean

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

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

Data type

boolean

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

Exclusion Criteria

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

Chemotherapy Recently

Data type

boolean

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

Trastuzumab Recently

Data type

boolean

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

Lapatinib Recently

Data type

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.
Description

Study Subject Participation Status | Clinical Trial Containing Trastuzumab emtansine

Data type

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.
Description

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

Data type

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
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Similar models

Eligibility Breast Cancer NCT01419197

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