ID

38128

Description

A Study of Patient Preference for Subcutaneous Versus Intravenous Herceptin (Trastuzumab) in Patients With HER2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Herceptin for at Least 3 Years; ODM derived from: https://clinicaltrials.gov/show/NCT01810393

Link

https://clinicaltrials.gov/show/NCT01810393

Keywords

Versions (1)
  1. 9/20/19 9/20/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01810393

English

Eligibility Breast Cancer NCT01810393

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
histologically or cytologically confirmed her2-positive metastatic breast cancer
Description

Secondary malignant neoplasm of female breast HER2 Positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C2348909
on treatment with first-line herceptin iv and free of disease progression for at least 3 years
Description

First line treatment Herceptin Intravenous | Free of Disease Progression

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C0338204
UMLS CUI [1,3]
C1522726
UMLS CUI [2,1]
C0332296
UMLS CUI [2,2]
C0242656
left ventricular ejection fraction (lvef) of >/= 50%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
hormonal therapy will be allowed
Description

Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1]
C0279025
prior use of anti-her2 therapy will be allowed
Description

HER2 Targeted Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C2985566
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
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 who have been disease-free for at least 5 years; patients with previous ductal carcinoma in situ of the breast are also eligible
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 DCIS

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]
C0007124
patients with severe dyspnea at rest or requiring supplementary oxygen therapy
Description

Resting Dyspnea Severe | Requirement Oxygen supplementation

Data type

boolean

Alias
UMLS CUI [1,1]
C0743330
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0919655
serious cardiac illness or medical conditions that would preclude the use of herceptin
Description

Heart Disease Serious | Medical condition Excludes Herceptin

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C0338204
hepatitis b, hepatitis c or hiv infection
Description

Hepatitis B | Hepatitis C | HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
pregnant or lactating women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
concurrent enrolment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Description

Study Subject Participation Status | Clinical Trial | Cancer treatment Investigational | Hormone Therapy | Diphosphonates | Immunotherapy

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
UMLS CUI [3,1]
C0920425
UMLS CUI [3,2]
C1517586
UMLS CUI [4]
C0279025
UMLS CUI [5]
C0012544
UMLS CUI [6]
C0021083
known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
Description

Hypersensitivity Trastuzumab | Hypersensitivity Murine protein | Hypersensitivity Herceptin Excipient | Hyaluronidase allergy | Hypersensitivity Adhesive Device subcutaneous | Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0728747
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1699668
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0338204
UMLS CUI [3,3]
C0015237
UMLS CUI [4]
C0572015
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0001516
UMLS CUI [5,3]
C0025080
UMLS CUI [5,4]
C0443315
UMLS CUI [6]
C2220378
UMLS CUI [7,1]
C0301873
UMLS CUI [7,2]
C0205082
UMLS CUI [8,1]
C0332218
UMLS CUI [8,2]
C0004096
UMLS CUI [8,3]
C2587213
central nervous system (cns) metastases unless they have been treated and have been stable for at least 3 months
Description

CNS metastases | Exception CNS metastases Treated | Exception CNS metastases Stable

Data type

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0686377
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0686377
UMLS CUI [3,3]
C0205360
inadequate organ function
Description

Organ function Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0678852
UMLS CUI [1,2]
C0205412
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Similar models

Eligibility Breast Cancer NCT01810393

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Secondary malignant neoplasm of female breast HER2 Positive
Item
histologically or cytologically confirmed her2-positive metastatic breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
First line treatment Herceptin Intravenous | Free of Disease Progression
Item
on treatment with first-line herceptin iv and free of disease progression for at least 3 years
boolean
C1708063 (UMLS CUI [1,1])
C0338204 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])
C0332296 (UMLS CUI [2,1])
C0242656 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) of >/= 50%
boolean
C0428772 (UMLS CUI [1])
Hormone Therapy
Item
hormonal therapy will be allowed
boolean
C0279025 (UMLS CUI [1])
HER2 Targeted Therapy
Item
prior use of anti-her2 therapy will be allowed
boolean
C0069515 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
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 DCIS
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 who have been disease-free for at least 5 years; patients with previous ductal carcinoma in situ of the breast are also eligible
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])
C0007124 (UMLS CUI [6,2])
Resting Dyspnea Severe | Requirement Oxygen supplementation
Item
patients with severe dyspnea at rest or requiring supplementary oxygen therapy
boolean
C0743330 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0919655 (UMLS CUI [2,2])
Heart Disease Serious | Medical condition Excludes Herceptin
Item
serious cardiac illness or medical conditions that would preclude the use of herceptin
boolean
C0018799 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C0338204 (UMLS CUI [2,3])
Hepatitis B | Hepatitis C | HIV Infection
Item
hepatitis b, hepatitis c or hiv infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
pregnant or lactating women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial | Cancer treatment Investigational | Hormone Therapy | Diphosphonates | Immunotherapy
Item
concurrent enrolment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0920425 (UMLS CUI [3,1])
C1517586 (UMLS CUI [3,2])
C0279025 (UMLS CUI [4])
C0012544 (UMLS CUI [5])
C0021083 (UMLS CUI [6])
Hypersensitivity Trastuzumab | Hypersensitivity Murine protein | Hypersensitivity Herceptin Excipient | Hyaluronidase allergy | Hypersensitivity Adhesive Device subcutaneous | Severe allergic reaction | Immunologic reaction Severe | Difficulty with Asthma Control
Item
known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma
boolean
C0020517 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1699668 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C0338204 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0572015 (UMLS CUI [4])
C0020517 (UMLS CUI [5,1])
C0001516 (UMLS CUI [5,2])
C0025080 (UMLS CUI [5,3])
C0443315 (UMLS CUI [5,4])
C2220378 (UMLS CUI [6])
C0301873 (UMLS CUI [7,1])
C0205082 (UMLS CUI [7,2])
C0332218 (UMLS CUI [8,1])
C0004096 (UMLS CUI [8,2])
C2587213 (UMLS CUI [8,3])
CNS metastases | Exception CNS metastases Treated | Exception CNS metastases Stable
Item
central nervous system (cns) metastases unless they have been treated and have been stable for at least 3 months
boolean
C0686377 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0686377 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0686377 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Organ function Inadequate
Item
inadequate organ function
boolean
C0678852 (UMLS CUI [1,1])
C0205412 (UMLS CUI [1,2])
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