ID

38055

Description

A Safety and Tolerability Study of Assisted- and Self-Administered Subcutaneous Herceptin (Trastuzumab) as Adjuvant Therapy in Patients With Early HER2-Positive Breast Cancer (SafeHer); ODM derived from: https://clinicaltrials.gov/show/NCT01566721

Link

https://clinicaltrials.gov/show/NCT01566721

Keywords

Versions (1)
  1. 9/12/19 9/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 12, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01566721

English

Eligibility Breast Cancer NCT01566721

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult male or female patients, >/= 18 years of age
Description

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically confirmed early invasive her2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage i to iiic that is eligible for adjuvant treatment with trastuzumab
Description

Invasive carcinoma of breast HER2 Positive Early | Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Disease TNM Breast tumor staging | Eligibility Trastuzumab Adjuvant therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C2348909
UMLS CUI [1,3]
C1279919
UMLS CUI [2,1]
C0543478
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0277556
UMLS CUI [3,2]
C1517927
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0012634
UMLS CUI [5,2]
C0474926
UMLS CUI [6,1]
C1548635
UMLS CUI [6,2]
C0728747
UMLS CUI [6,3]
C0677850
eastern cooperative oncology group (ecog) performance status 0 or 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
screening left ventricular ejection fraction (lvef) >/= 55%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-her2 agent
Description

Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational

Data type

boolean

Alias
UMLS CUI [1,1]
C0600558
UMLS CUI [1,2]
C0678222
UMLS CUI [2,1]
C0677850
UMLS CUI [2,2]
C0678222
UMLS CUI [3]
C2267079
UMLS CUI [4,1]
C2267079
UMLS CUI [4,2]
C1517586
history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0007117
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C1707251
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0678222
past history of ductal carcinoma in situ that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops
Description

DCIS | Systemic therapy | Radiotherapy to breast Ipsilateral | Invasive cancer Progressing

Data type

boolean

Alias
UMLS CUI [1]
C0007124
UMLS CUI [2]
C1515119
UMLS CUI [3,1]
C0948310
UMLS CUI [3,2]
C0441989
UMLS CUI [4,1]
C0677898
UMLS CUI [4,2]
C0205329
metastatic disease
Description

Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0027627
inadequate bone marrow, hepatic or renal function
Description

Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205412
serious cardiac or cardiovascular disease
Description

Heart Disease Serious | Cardiovascular Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0007222
UMLS CUI [2,2]
C0205404
uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy
Description

Uncontrolled hypertension | Hypertensive crisis | Hypertensive Encephalopathy

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0020546
UMLS CUI [3]
C0151620
history of severe allergic or immunological reactions, e.g. difficult to control asthma
Description

Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control

Data type

boolean

Alias
UMLS CUI [1]
C2220378
UMLS CUI [2,1]
C0301873
UMLS CUI [2,2]
C0205082
UMLS CUI [3,1]
C0332218
UMLS CUI [3,2]
C0004096
UMLS CUI [3,3]
C2587213
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Breast Cancer NCT01566721

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult male or female patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast HER2 Positive Early | Residual disease Absent | Recurrent disease Locally Absent | Neoplasm Metastasis Absent | Disease TNM Breast tumor staging | Eligibility Trastuzumab Adjuvant therapy
Item
histologically confirmed early invasive her2-positive carcinoma of the breast with no evidence of residual, locally recurrent or metastatic disease and defined as clinical stage i to iiic that is eligible for adjuvant treatment with trastuzumab
boolean
C0853879 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C1279919 (UMLS CUI [1,3])
C0543478 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0277556 (UMLS CUI [3,1])
C1517927 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0027627 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0012634 (UMLS CUI [5,1])
C0474926 (UMLS CUI [5,2])
C1548635 (UMLS CUI [6,1])
C0728747 (UMLS CUI [6,2])
C0677850 (UMLS CUI [6,3])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction
Item
screening left ventricular ejection fraction (lvef) >/= 55%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | HER2 Receptor Antagonist | HER2 Receptor Antagonist Investigational
Item
previous neoadjuvant or adjuvant breast cancer treatment with an approved or investigational anti-her2 agent
boolean
C0600558 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C2267079 (UMLS CUI [3])
C2267079 (UMLS CUI [4,1])
C1517586 (UMLS CUI [4,2])
Cancer Other | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Basal cell carcinoma | Exception Curative treatment Cancer Other | Exception Disease Free Duration | Exception Breast Carcinoma
Item
history of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and patients with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0007117 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C1707251 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
C1705847 (UMLS CUI [6,1])
C0678222 (UMLS CUI [6,2])
DCIS | Systemic therapy | Radiotherapy to breast Ipsilateral | Invasive cancer Progressing
Item
past history of ductal carcinoma in situ that has been treated with any systemic therapy or with radiation therapy to the ipsilateral breast where the invasive cancer subsequently develops
boolean
C0007124 (UMLS CUI [1])
C1515119 (UMLS CUI [2])
C0948310 (UMLS CUI [3,1])
C0441989 (UMLS CUI [3,2])
C0677898 (UMLS CUI [4,1])
C0205329 (UMLS CUI [4,2])
Neoplasm Metastasis
Item
metastatic disease
boolean
C0027627 (UMLS CUI [1])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, hepatic or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
Heart Disease Serious | Cardiovascular Disease Serious
Item
serious cardiac or cardiovascular disease
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Uncontrolled hypertension | Hypertensive crisis | Hypertensive Encephalopathy
Item
uncontrolled hypertension, or history of hypertensive crisis or hypertensive encephalopathy
boolean
C1868885 (UMLS CUI [1])
C0020546 (UMLS CUI [2])
C0151620 (UMLS CUI [3])
Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control
Item
history of severe allergic or immunological reactions, e.g. difficult to control asthma
boolean
C2220378 (UMLS CUI [1])
C0301873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332218 (UMLS CUI [3,1])
C0004096 (UMLS CUI [3,2])
C2587213 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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