ID

26305

Beschreibung

Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Patients With HER2-Positive Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00712881

Link

https://clinicaltrials.gov/show/NCT00712881

Stichworte

Versionen (1)
  1. 16.10.17 16.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

16. Oktober 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00712881

Englisch

Eligibility Breast Cancer NCT00712881

1 Formulare  
Criteria
Beschreibung

Criteria

treatment-naive patients with stage ii or iii invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of human epidermal growth factor receptor 2 (her2).
Beschreibung

Therapy naive | Invasive carcinoma of breast TNM Breast tumor staging | erbB-2 Receptor Overexpression Tests

Datentyp

boolean

Alias
UMLS CUI [1]
C0919936
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0474926
UMLS CUI [3,1]
C0069515
UMLS CUI [3,2]
C1514559
UMLS CUI [3,3]
C0022885
patients have at least one bidimensionally measurable lesion according to the who criteria.
Beschreibung

Measurable lesion 2-Dimensional Quantity

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1705052
UMLS CUI [1,3]
C1265611
the patient has an eastern cooperative oncology group (ecog) performance status of 0 or 1.
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
the patient has an lvef of at least 55% as assessed by multiple-gated acquisition (muga) scan (preferred) or echocardiography.
Beschreibung

Left ventricular ejection fraction Multiple gated acquisition scanning | Left ventricular ejection fraction Echocardiography

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0521317
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
the patient has hematology and serum chemistry laboratory test results within specific protocol-defined ranges.
Beschreibung

Hematology finding | Serum Chemistry Measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0474523
UMLS CUI [2]
C1883010
women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug.
Beschreibung

Childbearing Potential Contraceptive methods

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
main exclusion criteria:
Beschreibung

Exclusion Criteria Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
the patient:
Beschreibung

Client Characteristics

Datentyp

boolean

Alias
UMLS CUI [1]
C0815172
has received previous cancer therapy for breast cancer.
Beschreibung

Cancer treatment Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0678222
has any history of chf, angina pectoris, or myocardial infarction.
Beschreibung

Congestive heart failure | Angina Pectoris | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0002962
UMLS CUI [3]
C0027051
has uncontrolled hypertension.
Beschreibung

Uncontrolled hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C1868885
has infection, peptic ulcer, or unstable diabetes mellitus.
Beschreibung

Communicable Disease | Peptic Ulcer | Brittle diabetes

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0030920
UMLS CUI [3]
C0342302
has been treated with live virus vaccines within 8 weeks before the first administration of study drug.
Beschreibung

Vaccines, Attenuated

Datentyp

boolean

Alias
UMLS CUI [1]
C0042211
has impaired hepatic or renal function.
Beschreibung

Liver Dysfunction | Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0086565
UMLS CUI [2]
C1565489
is a pregnant or lactating woman. (any women becoming pregnant during the study will be withdrawn from the study.)
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
has used an investigational drug within one month before the screening visit.
Beschreibung

Investigational New Drugs

Datentyp

boolean

Alias
UMLS CUI [1]
C0013230
has a known hypersensitivity to any of the study drugs or to their active ingredients.
Beschreibung

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Active ingredient

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013230
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0013230
UMLS CUI [2,3]
C1372955
has an inflammatory breast cancer.
Beschreibung

Inflammatory Breast Carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0278601
has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
Beschreibung

Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0007117
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0553723
UMLS CUI [4,3]
C1522326
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Ähnliche Modelle

Eligibility Breast Cancer NCT00712881

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Therapy naive | Invasive carcinoma of breast TNM Breast tumor staging | erbB-2 Receptor Overexpression Tests
Item
treatment-naive patients with stage ii or iii invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of human epidermal growth factor receptor 2 (her2).
boolean
C0919936 (UMLS CUI [1])
C0853879 (UMLS CUI [2,1])
C0474926 (UMLS CUI [2,2])
C0069515 (UMLS CUI [3,1])
C1514559 (UMLS CUI [3,2])
C0022885 (UMLS CUI [3,3])
Measurable lesion 2-Dimensional Quantity
Item
patients have at least one bidimensionally measurable lesion according to the who criteria.
boolean
C1513041 (UMLS CUI [1,1])
C1705052 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
ECOG performance status
Item
the patient has an eastern cooperative oncology group (ecog) performance status of 0 or 1.
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Multiple gated acquisition scanning | Left ventricular ejection fraction Echocardiography
Item
the patient has an lvef of at least 55% as assessed by multiple-gated acquisition (muga) scan (preferred) or echocardiography.
boolean
C0428772 (UMLS CUI [1,1])
C0521317 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
Hematology finding | Serum Chemistry Measurement
Item
the patient has hematology and serum chemistry laboratory test results within specific protocol-defined ranges.
boolean
C0474523 (UMLS CUI [1])
C1883010 (UMLS CUI [2])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
main exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Client Characteristics
Item
the patient:
boolean
C0815172 (UMLS CUI [1])
Cancer treatment Breast Carcinoma
Item
has received previous cancer therapy for breast cancer.
boolean
C0920425 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
Congestive heart failure | Angina Pectoris | Myocardial Infarction
Item
has any history of chf, angina pectoris, or myocardial infarction.
boolean
C0018802 (UMLS CUI [1])
C0002962 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
Uncontrolled hypertension
Item
has uncontrolled hypertension.
boolean
C1868885 (UMLS CUI [1])
Communicable Disease | Peptic Ulcer | Brittle diabetes
Item
has infection, peptic ulcer, or unstable diabetes mellitus.
boolean
C0009450 (UMLS CUI [1])
C0030920 (UMLS CUI [2])
C0342302 (UMLS CUI [3])
Vaccines, Attenuated
Item
has been treated with live virus vaccines within 8 weeks before the first administration of study drug.
boolean
C0042211 (UMLS CUI [1])
Liver Dysfunction | Renal Insufficiency
Item
has impaired hepatic or renal function.
boolean
C0086565 (UMLS CUI [1])
C1565489 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
is a pregnant or lactating woman. (any women becoming pregnant during the study will be withdrawn from the study.)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
has used an investigational drug within one month before the screening visit.
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Active ingredient
Item
has a known hypersensitivity to any of the study drugs or to their active ingredients.
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1372955 (UMLS CUI [2,3])
Inflammatory Breast Carcinoma
Item
has an inflammatory breast cancer.
boolean
C0278601 (UMLS CUI [1])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated
Item
has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
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