ID

29825

Description

A Trial l of Panobinostat Given in Combination With Trastuzumab and Paclitaxel in Adult Female Patients With HER2 Positive Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00788931

Link

https://clinicaltrials.gov/show/NCT00788931

Keywords

Versions (1)
  1. 4/22/18 4/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility HER-2 Positive Breast Cancer NCT00788931

English

Eligibility HER-2 Positive Breast Cancer NCT00788931

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+ 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 organ functions
Description

Organ function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
eastern cooperative oncology group (ecog) performance status of ≤ 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have had surgery within last 2 weeks prior to starting the treatment
Description

Operative Surgical Procedures

Data type

boolean

Alias
UMLS CUI [1]
C0543467
patients who receive concurrent therapy for brain metastases
Description

Therapeutic procedure Metastatic malignant neoplasm to brain

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0220650
impaired heart function or clinically significant heart disease
Description

Decreased cardiac function | Heart Disease

Data type

boolean

Alias
UMLS CUI [1]
C0232166
UMLS CUI [2]
C0018799
ongoing diarrhea
Description

Diarrhea

Data type

boolean

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

Liver diseases | Kidney Diseases | 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 other protocol-defined inclusion/exclusion criteria may apply
Description

Contraceptive methods Unwilling | Clinical Trial Eligibility Criteria Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0700589
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C1516637
UMLS CUI [2,2]
C2348563
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Similar models

Eligibility HER-2 Positive Breast Cancer NCT00788931

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+ 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])
Organ function
Item
patients must have adequate organ functions
boolean
C0678852 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 1
boolean
C1520224 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Operative Surgical Procedures
Item
patients who have had surgery within last 2 weeks prior to starting the treatment
boolean
C0543467 (UMLS CUI [1])
Therapeutic procedure Metastatic malignant neoplasm to brain
Item
patients who receive concurrent therapy for brain metastases
boolean
C0087111 (UMLS CUI [1,1])
C0220650 (UMLS CUI [1,2])
Decreased cardiac function | Heart Disease
Item
impaired heart function or clinically significant heart disease
boolean
C0232166 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
Diarrhea
Item
ongoing diarrhea
boolean
C0011991 (UMLS CUI [1])
Liver diseases | Kidney Diseases | 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 | Clinical Trial Eligibility Criteria Study Protocol
Item
patients not willing to use an effective method of birth control other protocol-defined inclusion/exclusion criteria may apply
boolean
C0700589 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C1516637 (UMLS CUI [2,1])
C2348563 (UMLS CUI [2,2])
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