ID

43679

Description

Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02226276

Link

https://clinicaltrials.gov/show/NCT02226276

Keywords

Versions (2)
  1. 4/26/16 4/26/16 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Bone Metastases NCT02226276

English

Eligibility Bone Metastases NCT02226276

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women with metastatic her2-positive breast cancers whose disease has progressed on first-line trastuzumab + chemotherapy will be considered eligible for study participation if they meet the following criteria:
Description

Woman Metastatic HER2-positive carcinoma of breast | First line treatment Trastuzumab | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C1960398
UMLS CUI [1,3]
C0036525
UMLS CUI [2,1]
C1708063
UMLS CUI [2,2]
C0728747
UMLS CUI [3]
C0392920
participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained within 28 days prior to enrollment; patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
Description

Woman Carcinoma breast stage IV | Biopsy | Metastatic Neoplasm Lung | Metastatic Neoplasm Liver | Metastatic Neoplasm soft tissue | Metastatic Neoplasm Skeletal bone

Data type

boolean

Alias
UMLS CUI [1,1]
C0043210
UMLS CUI [1,2]
C0278488
UMLS CUI [2]
C0005558
UMLS CUI [3,1]
C2939420
UMLS CUI [3,2]
C0024109
UMLS CUI [4,1]
C2939420
UMLS CUI [4,2]
C0023884
UMLS CUI [5,1]
C2939420
UMLS CUI [5,2]
C0225317
UMLS CUI [6,1]
C2939420
UMLS CUI [6,2]
C0262950
at least 1 site of metastasis >= 20 mm in mean diameter must be identified
Description

Neoplasm Metastasis Site Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0205145
UMLS CUI [1,3]
C1301886
the cancer must over express her2 as determined by immunohistochemistry (ihc) and/or fluorescence in situ hybridization (fish)
Description

Quantitative HER2 immunohistochemistry (IHC) evaluation of breast cancer | Fluorescent in Situ Hybridization

Data type

boolean

Alias
UMLS CUI [1]
C3248285
UMLS CUI [2]
C0162789
patients may not have received trastuzumab within 6 weeks of projected 64cu-dota-trastuzumab/pet-ct
Description

trastuzumab | 64Cu-DOTA-trastuzumab | PET/CT scan

Data type

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2]
C2745103
UMLS CUI [3]
C1699633
participants must have normal cardiac ejection fraction
Description

Normal cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C3661818
planned therapy with ado-trastuzumab emtansine
Description

Planned Therapeutic procedure ado-trastuzumab emtansine

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C2935436
ability to provide informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patients that may need dose reduction to commence cycle 1 treatment
Description

Dosage Reduced | Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0178602
UMLS CUI [1,2]
C0392756
UMLS CUI [2]
C0087111
eastern cooperative oncology group (ecog) performance status of 0-2
Description

ECOG Performance Status 0 | ECOG Performance Status 1 | ECOG Performance Status 2

Data type

boolean

Alias
UMLS CUI [1]
C3830346
UMLS CUI [2]
C3830345
UMLS CUI [3]
C3830344
negative serum pregnancy test (female of childbearing potential only)
Description

Serum pregnancy test negative Female Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1,1]
C0430061
UMLS CUI [1,2]
C0086287
UMLS CUI [1,3]
C3831118
patients must have adequate cardiac function; left ventricular ejection fraction (lvef) >= 50% as determined by multi gated acquisition (muga) scan or echocardiogram
Description

Cardiac function | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0521317
UMLS CUI [4]
C0013516
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who have received trastuzumab within the prior 36 days
Description

Received trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C1514756
UMLS CUI [1,2]
C0728747
participants who are not considered candidates for ado-trastuzumab-emtansine
Description

Not Eligible | ado-trastuzumab emtansine

Data type

boolean

Alias
UMLS CUI [1]
C1555471
UMLS CUI [2]
C2935436
no metastatic sites >= 20 mm
Description

site, metastatic cancer

Data type

boolean

Alias
UMLS CUI [1]
C0280457
concurrent malignancy other than skin cancer
Description

Malignant Neoplasm Other | Malignant neoplasm of skin

Data type

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0007114
inability to provide informed consent
Description

Unable Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C1299582
UMLS CUI [1,2]
C0021430
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Similar models

Eligibility Bone Metastases NCT02226276

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Woman Metastatic HER2-positive carcinoma of breast | First line treatment Trastuzumab | Chemotherapy
Item
women with metastatic her2-positive breast cancers whose disease has progressed on first-line trastuzumab + chemotherapy will be considered eligible for study participation if they meet the following criteria:
boolean
C0043210 (UMLS CUI [1,1])
C1960398 (UMLS CUI [1,2])
C0036525 (UMLS CUI [1,3])
C1708063 (UMLS CUI [2,1])
C0728747 (UMLS CUI [2,2])
C0392920 (UMLS CUI [3])
Woman Carcinoma breast stage IV | Biopsy | Metastatic Neoplasm Lung | Metastatic Neoplasm Liver | Metastatic Neoplasm soft tissue | Metastatic Neoplasm Skeletal bone
Item
participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla; biopsy must be obtained within 28 days prior to enrollment; patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible)
boolean
C0043210 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
C0005558 (UMLS CUI [2])
C2939420 (UMLS CUI [3,1])
C0024109 (UMLS CUI [3,2])
C2939420 (UMLS CUI [4,1])
C0023884 (UMLS CUI [4,2])
C2939420 (UMLS CUI [5,1])
C0225317 (UMLS CUI [5,2])
C2939420 (UMLS CUI [6,1])
C0262950 (UMLS CUI [6,2])
Neoplasm Metastasis Site Diameter
Item
at least 1 site of metastasis >= 20 mm in mean diameter must be identified
boolean
C0027627 (UMLS CUI [1,1])
C0205145 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Quantitative HER2 immunohistochemistry (IHC) evaluation of breast cancer | Fluorescent in Situ Hybridization
Item
the cancer must over express her2 as determined by immunohistochemistry (ihc) and/or fluorescence in situ hybridization (fish)
boolean
C3248285 (UMLS CUI [1])
C0162789 (UMLS CUI [2])
trastuzumab | 64Cu-DOTA-trastuzumab | PET/CT scan
Item
patients may not have received trastuzumab within 6 weeks of projected 64cu-dota-trastuzumab/pet-ct
boolean
C0728747 (UMLS CUI [1])
C2745103 (UMLS CUI [2])
C1699633 (UMLS CUI [3])
Normal cardiac ejection fraction
Item
participants must have normal cardiac ejection fraction
boolean
C3661818 (UMLS CUI [1])
Planned Therapeutic procedure ado-trastuzumab emtansine
Item
planned therapy with ado-trastuzumab emtansine
boolean
C0087111 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C2935436 (UMLS CUI [1,3])
Informed Consent
Item
ability to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Dosage Reduced | Therapeutic procedure
Item
patients that may need dose reduction to commence cycle 1 treatment
boolean
C0178602 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2])
ECOG Performance Status 0 | ECOG Performance Status 1 | ECOG Performance Status 2
Item
eastern cooperative oncology group (ecog) performance status of 0-2
boolean
C3830346 (UMLS CUI [1])
C3830345 (UMLS CUI [2])
C3830344 (UMLS CUI [3])
Serum pregnancy test negative Female Childbearing Potential
Item
negative serum pregnancy test (female of childbearing potential only)
boolean
C0430061 (UMLS CUI [1,1])
C0086287 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
Cardiac function | Left ventricular ejection fraction | Multiple gated acquisition scanning | Echocardiography
Item
patients must have adequate cardiac function; left ventricular ejection fraction (lvef) >= 50% as determined by multi gated acquisition (muga) scan or echocardiogram
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
C0013516 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Received trastuzumab
Item
participants who have received trastuzumab within the prior 36 days
boolean
C1514756 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
Not Eligible | ado-trastuzumab emtansine
Item
participants who are not considered candidates for ado-trastuzumab-emtansine
boolean
C1555471 (UMLS CUI [1])
C2935436 (UMLS CUI [2])
site, metastatic cancer
Item
no metastatic sites >= 20 mm
boolean
C0280457 (UMLS CUI [1])
Malignant Neoplasm Other | Malignant neoplasm of skin
Item
concurrent malignancy other than skin cancer
boolean
C0006826 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0007114 (UMLS CUI [2])
Unable Informed Consent
Item
inability to provide informed consent
boolean
C1299582 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
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