Eligibility Breast Cancer NCT01674062

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >=18 years of age, with histologically-confirmed her2-positive breast cancer
Beskrivning

Adult | Age | HER2-positive carcinoma of breast

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
UMLS CUI [3]
C1960398
metastatic breast cancer, with progression on herceptin-based therapy as last treatment for metastatic disease
Beskrivning

Secondary malignant neoplasm of female breast | Disease Progression | Therapeutic procedure Herceptin Based Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0338204
UMLS CUI [3,3]
C1705938
UMLS CUI [3,4]
C0027627
<=3 chemotherapy regimens prior to study entry
Beskrivning

Chemotherapy Regimen Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
last herceptin dose <=9 weeks before study entry for patients reciving pertuzumab +
Beskrivning

Herceptin Dose | pertuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0338204
UMLS CUI [1,2]
C0178602
UMLS CUI [2]
C1328025
herceptin, and >=4 weeks for patients receiving pertuzumab monotherapy
Beskrivning

Herceptin | pertuzumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0338204
UMLS CUI [2]
C1328025
lvef>= 55% at study entry
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with an anti-cancer vaccine or any targeted therapy other than herceptin
Beskrivning

Vaccines Against Malignant Neoplasms | Targeted Therapy | Herceptin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0521124
UMLS CUI [1,3]
C0006826
UMLS CUI [2]
C2985566
UMLS CUI [3]
C0338204
brain metastases
Beskrivning

Metastatic malignant neoplasm to brain

Datatyp

boolean

Alias
UMLS CUI [1]
C0220650
history of any cardiac ae related to herceptin therapy
Beskrivning

Adverse event cardiac Herceptin Related

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0338204
UMLS CUI [1,4]
C0439849
any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
Beskrivning

Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0007117
UMLS CUI [3]
C0851140

Similar models

Eligibility Breast Cancer NCT01674062

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age | HER2-positive carcinoma of breast
Item
adult patients, >=18 years of age, with histologically-confirmed her2-positive breast cancer
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C1960398 (UMLS CUI [3])
Secondary malignant neoplasm of female breast | Disease Progression | Therapeutic procedure Herceptin Based Neoplasm Metastasis
Item
metastatic breast cancer, with progression on herceptin-based therapy as last treatment for metastatic disease
boolean
C0346993 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
C0087111 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C1705938 (UMLS CUI [3,3])
C0027627 (UMLS CUI [3,4])
Chemotherapy Regimen Quantity
Item
<=3 chemotherapy regimens prior to study entry
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Herceptin Dose | pertuzumab
Item
last herceptin dose <=9 weeks before study entry for patients reciving pertuzumab +
boolean
C0338204 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C1328025 (UMLS CUI [2])
Herceptin | pertuzumab
Item
herceptin, and >=4 weeks for patients receiving pertuzumab monotherapy
boolean
C0338204 (UMLS CUI [1])
C1328025 (UMLS CUI [2])
Left ventricular ejection fraction
Item
lvef>= 55% at study entry
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Vaccines Against Malignant Neoplasms | Targeted Therapy | Herceptin
Item
previous treatment with an anti-cancer vaccine or any targeted therapy other than herceptin
boolean
C0042210 (UMLS CUI [1,1])
C0521124 (UMLS CUI [1,2])
C0006826 (UMLS CUI [1,3])
C2985566 (UMLS CUI [2])
C0338204 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Adverse event cardiac Herceptin Related
Item
history of any cardiac ae related to herceptin therapy
boolean
C0877248 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0338204 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
Malignant Neoplasms | Basal cell carcinoma | Carcinoma in situ of uterine cervix
Item
any other malignancy in the last 5 years, except for basal cell cancer or cancer in situ of the cervix
boolean
C0006826 (UMLS CUI [1])
C0007117 (UMLS CUI [2])
C0851140 (UMLS CUI [3])