ID

37996

Description

Patients' Preference of Herceptin (Trastuzumab) Subcutaneous Versus Intravenous Administration in HER2-positive Early Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01401166

Link

https://clinicaltrials.gov/show/NCT01401166

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 NCT01401166

English

Eligibility Breast Cancer NCT01401166

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
her2-positive breast cancer.
Description

HER2-positive carcinoma of breast

Data type

boolean

Alias
UMLS CUI [1]
C1960398
no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant).
Description

Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Status post Operative Surgical Procedure Completion | Status post Neoadjuvant Chemotherapy Completion | Status post Adjuvant Chemotherapy Completion

Data type

boolean

Alias
UMLS CUI [1,1]
C0543478
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C1517927
UMLS CUI [2,3]
C0332197
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0543467
UMLS CUI [4,3]
C0205197
UMLS CUI [5,1]
C0231290
UMLS CUI [5,2]
C0600558
UMLS CUI [5,3]
C3665472
UMLS CUI [5,4]
C0205197
UMLS CUI [6,1]
C0231290
UMLS CUI [6,2]
C0085533
UMLS CUI [6,3]
C0205197
all adjuvant chemotherapy must be completed; adjuvant radiotherapy may be ongoing.
Description

Adjuvant Chemotherapy Completed | Radiotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0085533
UMLS CUI [1,2]
C0205197
UMLS CUI [2]
C0242939
patients who have already received intravenous herceptin must have at least 8 out of the total planned 18 3-week cycles remaining.
Description

Herceptin Intravenous Pre-existing | Requirement Course Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0338204
UMLS CUI [1,2]
C1522726
UMLS CUI [1,3]
C2347662
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0750729
UMLS CUI [2,3]
C1265611
eastern cooperative oncology group (ecog) performance status 0 or 1.
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix or basal cell carcinoma, or other curatively treated malignancies that have been disease-free for at least 5 years.
Description

Cancer Other | Exception DCIS | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007124
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007117
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1273390
UMLS CUI [5,3]
C1707251
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0012634
UMLS CUI [6,3]
C0332296
UMLS CUI [6,4]
C0449238
inadequate bone marrow function.
Description

Bone Marrow function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
impaired liver function.
Description

Liver Dysfunction

Data type

boolean

Alias
UMLS CUI [1]
C0086565
inadequate renal function.
Description

Renal function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0232804
UMLS CUI [1,2]
C0205412
serious cardiovascular disease.
Description

Cardiovascular Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0205404
human immunodeficiency virus (hiv) or hepatitis b (hbv) or c (hcv) infection.
Description

HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0019163
UMLS CUI [3]
C0019196
prior maximum cumulative dose of doxorubicin > 360 mg/m^2 or epirubicin > 720 mg/m^2 or equivalent.
Description

Doxorubicin Cumulative Dose Maximum | Epirubicin Cumulative Dose Maximum | Doxorubicin Dose Equivalent | Epirubicin Dose Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C0014582
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0806909
UMLS CUI [3,1]
C0013089
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205163
UMLS CUI [4,1]
C0014582
UMLS CUI [4,2]
C0178602
UMLS CUI [4,3]
C0205163
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Similar models

Eligibility Breast Cancer NCT01401166

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, ≥ 18 years of age.
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
HER2-positive carcinoma of breast
Item
her2-positive breast cancer.
boolean
C1960398 (UMLS CUI [1])
Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Status post Operative Surgical Procedure Completion | Status post Neoadjuvant Chemotherapy Completion | Status post Adjuvant Chemotherapy Completion
Item
no evidence of residual, locally recurrent, or metastatic disease after completion of surgery and chemotherapy (neoadjuvant or adjuvant).
boolean
C0543478 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0543467 (UMLS CUI [4,2])
C0205197 (UMLS CUI [4,3])
C0231290 (UMLS CUI [5,1])
C0600558 (UMLS CUI [5,2])
C3665472 (UMLS CUI [5,3])
C0205197 (UMLS CUI [5,4])
C0231290 (UMLS CUI [6,1])
C0085533 (UMLS CUI [6,2])
C0205197 (UMLS CUI [6,3])
Adjuvant Chemotherapy Completed | Radiotherapy, Adjuvant
Item
all adjuvant chemotherapy must be completed; adjuvant radiotherapy may be ongoing.
boolean
C0085533 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0242939 (UMLS CUI [2])
Herceptin Intravenous Pre-existing | Requirement Course Quantity
Item
patients who have already received intravenous herceptin must have at least 8 out of the total planned 18 3-week cycles remaining.
boolean
C0338204 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0750729 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer Other | Exception DCIS | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration
Item
history of other malignancy, except for ductal carcinoma in situ of the breast, curatively treated carcinoma in situ of the cervix or basal cell carcinoma, or other curatively treated malignancies that have been disease-free for at least 5 years.
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007124 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851140 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1273390 (UMLS CUI [5,2])
C1707251 (UMLS CUI [5,3])
C1705847 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
C0449238 (UMLS CUI [6,4])
Bone Marrow function Inadequate
Item
inadequate bone marrow function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
Liver Dysfunction
Item
impaired liver function.
boolean
C0086565 (UMLS CUI [1])
Renal function Inadequate
Item
inadequate renal function.
boolean
C0232804 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
Cardiovascular Disease Serious
Item
serious cardiovascular disease.
boolean
C0007222 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
HIV Infection | Hepatitis B | Hepatitis C
Item
human immunodeficiency virus (hiv) or hepatitis b (hbv) or c (hcv) infection.
boolean
C0019693 (UMLS CUI [1])
C0019163 (UMLS CUI [2])
C0019196 (UMLS CUI [3])
Doxorubicin Cumulative Dose Maximum | Epirubicin Cumulative Dose Maximum | Doxorubicin Dose Equivalent | Epirubicin Dose Equivalent
Item
prior maximum cumulative dose of doxorubicin > 360 mg/m^2 or epirubicin > 720 mg/m^2 or equivalent.
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0014582 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0013089 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205163 (UMLS CUI [3,3])
C0014582 (UMLS CUI [4,1])
C0178602 (UMLS CUI [4,2])
C0205163 (UMLS CUI [4,3])
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