ID

37829

Description

Positron Emission Tomography in Women With Advanced HER2-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01093612

Link

https://clinicaltrials.gov/show/NCT01093612

Keywords

Versions (1)
  1. 8/26/19 8/26/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 26, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01093612

English

Eligibility Breast Cancer NCT01093612

1 forms  
Criteria
Description

Criteria

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 study. patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
Description

Gender | Invasive carcinoma of breast metastatic | Neoplasm Metastasis Absent Primary tumor Region | Neoplasm Metastasis Absent Axilla Region | Biopsy Required | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of soft tissues | Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0677930
UMLS CUI [3,4]
C0205147
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0004454
UMLS CUI [4,4]
C0205147
UMLS CUI [5,1]
C0005558
UMLS CUI [5,2]
C1514873
UMLS CUI [6]
C0153676
UMLS CUI [7]
C0494165
UMLS CUI [8]
C0684686
UMLS CUI [9]
C0153690
at least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
Description

Metastasis Site Quantity Diameter | Exception Liver | In addition to Site Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1301886
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023884
UMLS CUI [3,1]
C0332287
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C0005558
the cancer must over express her2 as determined by ihc and fish.
Description

Neoplasm HER2 Protein Overexpression Immunohistochemistry | Neoplasm HER2 Protein Overexpression FISH

Data type

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1515560
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0027651
UMLS CUI [2,2]
C1515560
UMLS CUI [2,3]
C0162789
patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
Description

Trastuzumab Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Trastuzumab Neoplasm Metastasis | Absence Trastuzumab Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C0027627
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0728747
UMLS CUI [4,3]
C0332185
participants must have normal cardiac ejection fraction.
Description

Normal cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C3661818
eligibility part 2 (correlation of her2 expression with pet uptake)
Description

Eligibility Part Number | Correlation HER2 Expression PET

Data type

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0449719
UMLS CUI [1,3]
C0237753
UMLS CUI [2,1]
C1707520
UMLS CUI [2,2]
C0242957
UMLS CUI [2,3]
C0017262
UMLS CUI [2,4]
C0032743
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 study. patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
Description

Gender | Invasive carcinoma of breast metastatic | Neoplasm Metastasis Absent Primary tumor Region | Neoplasm Metastasis Absent Axilla Region | Biopsy Required | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of soft tissues | Secondary malignant neoplasm of bone

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C1522484
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0677930
UMLS CUI [3,4]
C0205147
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0004454
UMLS CUI [4,4]
C0205147
UMLS CUI [5,1]
C0005558
UMLS CUI [5,2]
C1514873
UMLS CUI [6]
C0153676
UMLS CUI [7]
C0494165
UMLS CUI [8]
C0684686
UMLS CUI [9]
C0153690
at least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
Description

Metastasis Site Quantity Diameter | Exception Liver | In addition to Site Biopsy

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C1265611
UMLS CUI [1,4]
C1301886
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0023884
UMLS CUI [3,1]
C0332287
UMLS CUI [3,2]
C1515974
UMLS CUI [3,3]
C0005558
participants with her2 1+, 2+ and 3+ by ihc are eligible.
Description

HER2 Immunohistochemistry

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C0021044
patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
Description

Trastuzumab Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Trastuzumab Neoplasm Metastasis | Absence Trastuzumab Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C0677850
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C0600558
UMLS CUI [3,1]
C0728747
UMLS CUI [3,2]
C0027627
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0728747
UMLS CUI [4,3]
C0332185
participants must have normal cardiac ejection fraction.
Description

Normal cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C3661818
ineligibility
Description

Ineligibility

Data type

boolean

Alias
UMLS CUI [1]
C1512714
participants who have received trastuzumab within the prior 2 months
Description

Trastuzumab Received Recently

Data type

boolean

Alias
UMLS CUI [1,1]
C0728747
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C0332185
participants who are not considered candidates for trastuzumab
Description

Study Subject Inappropriate Trastuzumab

Data type

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0728747
metastatic disease in a single site
Description

Neoplasm Metastasis Site Single

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205171
no metastatic site greater than or equal to 2 cm
Description

Neoplasm Metastasis Site Size

Data type

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C1515974
UMLS CUI [1,3]
C0205171
concurrent malignancy other than skin cancer
Description

Cancer Other | Exception Skin carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
inability to provide informed consent
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
participants who are pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Breast Cancer NCT01093612

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Gender | Invasive carcinoma of breast metastatic | Neoplasm Metastasis Absent Primary tumor Region | Neoplasm Metastasis Absent Axilla Region | Biopsy Required | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of soft tissues | Secondary malignant neoplasm of 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 study. patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677930 (UMLS CUI [3,3])
C0205147 (UMLS CUI [3,4])
C0027627 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0004454 (UMLS CUI [4,3])
C0205147 (UMLS CUI [4,4])
C0005558 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0153676 (UMLS CUI [6])
C0494165 (UMLS CUI [7])
C0684686 (UMLS CUI [8])
C0153690 (UMLS CUI [9])
Metastasis Site Quantity Diameter | Exception Liver | In addition to Site Biopsy
Item
at least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0332287 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C0005558 (UMLS CUI [3,3])
Neoplasm HER2 Protein Overexpression Immunohistochemistry | Neoplasm HER2 Protein Overexpression FISH
Item
the cancer must over express her2 as determined by ihc and fish.
boolean
C0027651 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0027651 (UMLS CUI [2,1])
C1515560 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
Trastuzumab Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Trastuzumab Neoplasm Metastasis | Absence Trastuzumab Recently
Item
patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
boolean
C0728747 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C0332185 (UMLS CUI [4,3])
Normal cardiac ejection fraction
Item
participants must have normal cardiac ejection fraction.
boolean
C3661818 (UMLS CUI [1])
Eligibility Part Number | Correlation HER2 Expression PET
Item
eligibility part 2 (correlation of her2 expression with pet uptake)
boolean
C1548635 (UMLS CUI [1,1])
C0449719 (UMLS CUI [1,2])
C0237753 (UMLS CUI [1,3])
C1707520 (UMLS CUI [2,1])
C0242957 (UMLS CUI [2,2])
C0017262 (UMLS CUI [2,3])
C0032743 (UMLS CUI [2,4])
Gender | Invasive carcinoma of breast metastatic | Neoplasm Metastasis Absent Primary tumor Region | Neoplasm Metastasis Absent Axilla Region | Biopsy Required | Secondary malignant neoplasm of lung | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of soft tissues | Secondary malignant neoplasm of 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 study. patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible).
boolean
C0079399 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C1522484 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0677930 (UMLS CUI [3,3])
C0205147 (UMLS CUI [3,4])
C0027627 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0004454 (UMLS CUI [4,3])
C0205147 (UMLS CUI [4,4])
C0005558 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
C0153676 (UMLS CUI [6])
C0494165 (UMLS CUI [7])
C0684686 (UMLS CUI [8])
C0153690 (UMLS CUI [9])
Metastasis Site Quantity Diameter | Exception Liver | In addition to Site Biopsy
Item
at least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied.
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1301886 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0023884 (UMLS CUI [2,2])
C0332287 (UMLS CUI [3,1])
C1515974 (UMLS CUI [3,2])
C0005558 (UMLS CUI [3,3])
HER2 Immunohistochemistry
Item
participants with her2 1+, 2+ and 3+ by ihc are eligible.
boolean
C0069515 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
Trastuzumab Adjuvant therapy | Trastuzumab Neoadjuvant Therapy | Trastuzumab Neoplasm Metastasis | Absence Trastuzumab Recently
Item
patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months.
boolean
C0728747 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C0600558 (UMLS CUI [2,2])
C0728747 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0728747 (UMLS CUI [4,2])
C0332185 (UMLS CUI [4,3])
Normal cardiac ejection fraction
Item
participants must have normal cardiac ejection fraction.
boolean
C3661818 (UMLS CUI [1])
Ineligibility
Item
ineligibility
boolean
C1512714 (UMLS CUI [1])
Trastuzumab Received Recently
Item
participants who have received trastuzumab within the prior 2 months
boolean
C0728747 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
Study Subject Inappropriate Trastuzumab
Item
participants who are not considered candidates for trastuzumab
boolean
C0681850 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
Neoplasm Metastasis Site Single
Item
metastatic disease in a single site
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
Neoplasm Metastasis Site Size
Item
no metastatic site greater than or equal to 2 cm
boolean
C0027627 (UMLS CUI [1,1])
C1515974 (UMLS CUI [1,2])
C0205171 (UMLS CUI [1,3])
Cancer Other | Exception Skin carcinoma
Item
concurrent malignancy other than skin cancer
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
Informed Consent Unable
Item
inability to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Pregnancy
Item
participants who are pregnant
boolean
C0032961 (UMLS CUI [1])
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