ID

26084

Description

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

Keywords

Versions (1)
  1. 10/9/17 10/9/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 9, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00567879

English

Eligibility Breast Cancer NCT00567879

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age > 18 year old
Description

Age

Data type

boolean

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

Secondary malignant neoplasm of female breast HER2/Neu Positive

Data type

boolean

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

Trastuzumab | Disease Progression

Data type

boolean

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

Normal Laboratory Test Result

Data type

boolean

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

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

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.
Description

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

Data type

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
Description

Cardiac function Impaired | Heart Disease

Data type

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
Description

Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption LBH589

Data type

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
Description

Diarrhea

Data type

boolean

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

Liver disease | Kidney Disease | Liver Dysfunction | Renal Insufficiency

Data type

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
Description

Cancer treatment | Antineoplastic Agents

Data type

boolean

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

Pregnancy | Breast Feeding

Data type

boolean

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

Contraceptive methods Unwilling

Data type

boolean

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

Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Breast Cancer NCT00567879

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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