ID

26084

Beschreibung

A Trial of Panobinostat and Trastuzumab for Adult Female Patients With HER2 Positive Metastatic Breast Cancer Whose Disease Has Progressed on or After Trastuzumab; ODM derived from: https://clinicaltrials.gov/show/NCT00567879

Link

https://clinicaltrials.gov/show/NCT00567879

Stichworte

Versionen (1)
  1. 09.10.17 09.10.17 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

9. Oktober 2017

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00567879

Englisch

Eligibility Breast Cancer NCT00567879

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 year old
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
confirmed her2+ ve metastatic breast cancer
Beschreibung

Secondary malignant neoplasm of female breast HER2/Neu Positive

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0346993
UMLS CUI [1,2]
C2348909
prior treatment and progression on trastuzumab
Beschreibung

Trastuzumab | Disease Progression

Datentyp

boolean

Alias
UMLS CUI [1]
C0728747
UMLS CUI [2]
C0242656
patients must have adequate laboratory values
Beschreibung

Normal Laboratory Test Result

Datentyp

boolean

Alias
UMLS CUI [1]
C0438214
eastern cooperative oncology group (ecog) performance status of <2
Beschreibung

ECOG performance status

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients with active central nervous system (cns) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
Beschreibung

CNS disorder | Metastatic malignant neoplasm to brain | Exception Prior Therapy | Exception Stable status

Datentyp

boolean

Alias
UMLS CUI [1]
C0007682
UMLS CUI [2]
C0220650
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1514463
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0205360
impaired heart function or clinically significant heart disease
Beschreibung

Cardiac function Impaired | Heart Disease

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0221099
UMLS CUI [2]
C0018799
impairment of gastrointestinal (gi) function, or gi disease that may significantly alter the absorption of lbh589
Beschreibung

Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption LBH589

Datentyp

boolean

Alias
UMLS CUI [1]
C0232459
UMLS CUI [2,1]
C0017178
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1566164
ongoing diarrhea
Beschreibung

Diarrhea

Datentyp

boolean

Alias
UMLS CUI [1]
C0011991
liver or renal disease with impaired hepatic or renal functions
Beschreibung

Liver disease | Kidney Disease | Liver Dysfunction | Renal Insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0086565
UMLS CUI [4]
C1565489
concomitant use of any anti-cancer therapy or certain drugs
Beschreibung

Cancer treatment | Antineoplastic Agents

Datentyp

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0003392
female patients who are pregnant or breast feeding
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
patients not willing to use an effective method of birth control
Beschreibung

Contraceptive methods Unwilling

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
other protocol-defined inclusion/exclusion criteria may apply
Beschreibung

Clinical Trial Eligibility Criteria Study Protocol

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Ähnliche Modelle

Eligibility Breast Cancer NCT00567879

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age > 18 year old
boolean
C0001779 (UMLS CUI [1])
Secondary malignant neoplasm of female breast HER2/Neu Positive
Item
confirmed her2+ ve metastatic breast cancer
boolean
C0346993 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Trastuzumab | Disease Progression
Item
prior treatment and progression on trastuzumab
boolean
C0728747 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Normal Laboratory Test Result
Item
patients must have adequate laboratory values
boolean
C0438214 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of <2
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
CNS disorder | Metastatic malignant neoplasm to brain | Exception Prior Therapy | Exception Stable status
Item
patients with active central nervous system (cns) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months.
boolean
C0007682 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C1514463 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0205360 (UMLS CUI [4,2])
Cardiac function Impaired | Heart Disease
Item
impaired heart function or clinically significant heart disease
boolean
C0232164 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption LBH589
Item
impairment of gastrointestinal (gi) function, or gi disease that may significantly alter the absorption of lbh589
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1566164 (UMLS CUI [2,4])
Diarrhea
Item
ongoing diarrhea
boolean
C0011991 (UMLS CUI [1])
Liver disease | Kidney Disease | Liver Dysfunction | Renal Insufficiency
Item
liver or renal disease with impaired hepatic or renal functions
boolean
C0023895 (UMLS CUI [1])
C0022658 (UMLS CUI [2])
C0086565 (UMLS CUI [3])
C1565489 (UMLS CUI [4])
Cancer treatment | Antineoplastic Agents
Item
concomitant use of any anti-cancer therapy or certain drugs
boolean
C0920425 (UMLS CUI [1])
C0003392 (UMLS CUI [2])
Pregnancy | Breast Feeding
Item
female patients who are pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Contraceptive methods Unwilling
Item
patients not willing to use an effective method of birth control
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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