ID

40428

Description

Phase Ib/II Trial of BEZ235 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01495247

Link

https://clinicaltrials.gov/show/NCT01495247

Keywords

Versions (1)
  1. 4/20/20 4/20/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 20, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Inoperable Locally Advanced Breast Cancer NCT01495247

English

Eligibility Inoperable Locally Advanced Breast Cancer NCT01495247

1 forms  
Criteria
Description

Criteria

females with breast cancer that is histologically or cytologically confirmed, her2 negative and locally advanced or metastatic as confirmed by radiology
Description

Gender | Breast Carcinoma HER2 Negative Advanced Locally | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C2348908
UMLS CUI [2,3]
C0205179
UMLS CUI [2,4]
C1517927
UMLS CUI [3]
C0346993
ecog performance status 0 and 1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
adequate bone marrow and organ function
Description

Bone Marrow function | Organ function

Data type

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
exclusion criteria (phase lb):
Description

Exclusion Criteria

Data type

boolean

Alias
UMLS CUI [1]
C0680251
previous treatment with pi3k and/or mtor inhibitors
Description

PI3K Inhibitor | mTOR Inhibitor

Data type

boolean

Alias
UMLS CUI [1]
C1519050
UMLS CUI [2]
C2746052
symptomatic central nervous system (cns) metastases
Description

CNS metastases Symptomatic

Data type

boolean

Alias
UMLS CUI [1,1]
C0686377
UMLS CUI [1,2]
C0231220
concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
Description

Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0006826
wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
Description

Therapeutic radiology procedure Field Wide | Palliative course of radiotherapy Field Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1882536
UMLS CUI [1,3]
C0332464
UMLS CUI [2,1]
C0475092
UMLS CUI [2,2]
C1882536
UMLS CUI [2,3]
C0439801
active cardiac disease (e.g. lvef less than institutional lower limit of normal, qtcf > 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
Description

Heart Disease | Left ventricular ejection fraction | QTcF Prolongation | Angina, Unstable | Ventricular arrhythmia | Supraventricular arrhythmia | Nodal rhythm disorder

Data type

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0428772
UMLS CUI [3]
C3828431
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0085612
UMLS CUI [6]
C0428974
UMLS CUI [7]
C0264893
inadequately controlled hypertension
Description

Poor hypertension control

Data type

boolean

Alias
UMLS CUI [1]
C0421190
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235 and/or paclitaxel
Description

Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption BEZ235 | Gastrointestinal Disease Changing Absorption Paclitaxel

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]
C2347425
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0392747
UMLS CUI [3,3]
C0237442
UMLS CUI [3,4]
C0144576
treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists
Description

Pharmaceutical Preparations At risk Torsades de Pointes | CYP3A4 Inhibitors Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Moderate | CYP3A4 Inducers Strong | Warfarin Analogue | Coumadin Analogue | Luteinizing Hormone-releasing Hormone Agonist

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C1444641
UMLS CUI [1,3]
C0040479
UMLS CUI [2,1]
C3850053
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C3850053
UMLS CUI [3,2]
C0442821
UMLS CUI [4,1]
C3850041
UMLS CUI [4,2]
C0205081
UMLS CUI [5,1]
C3850041
UMLS CUI [5,2]
C0442821
UMLS CUI [6,1]
C0043031
UMLS CUI [6,2]
C0243071
UMLS CUI [7,1]
C0699129
UMLS CUI [7,2]
C0243071
UMLS CUI [8]
C1518041
sensitivity to paclitaxel treatment
Description

Paclitaxel allergy

Data type

boolean

Alias
UMLS CUI [1]
C0570707
uncontrolled diabetes mellitus
Description

Diabetic - poor control

Data type

boolean

Alias
UMLS CUI [1]
C0421258
pregnant or nursing (lactating) woman
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
other protocol-defined inclusion/exclusion criteria may apply
Description

Eligibility Criteria Additional

Data type

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Similar models

Eligibility Inoperable Locally Advanced Breast Cancer NCT01495247

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Gender | Breast Carcinoma HER2 Negative Advanced Locally | Secondary malignant neoplasm of female breast
Item
females with breast cancer that is histologically or cytologically confirmed, her2 negative and locally advanced or metastatic as confirmed by radiology
boolean
C0079399 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0205179 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C0346993 (UMLS CUI [3])
ECOG performance status
Item
ecog performance status 0 and 1
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Organ function
Item
adequate bone marrow and organ function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Exclusion Criteria
Item
exclusion criteria (phase lb):
boolean
C0680251 (UMLS CUI [1])
PI3K Inhibitor | mTOR Inhibitor
Item
previous treatment with pi3k and/or mtor inhibitors
boolean
C1519050 (UMLS CUI [1])
C2746052 (UMLS CUI [2])
CNS metastases Symptomatic
Item
symptomatic central nervous system (cns) metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Malignant Neoplasms
Item
concurrent malignancy or malignancy in the last 5 years prior to start of study treatment
boolean
C0006826 (UMLS CUI [1])
Therapeutic radiology procedure Field Wide | Palliative course of radiotherapy Field Limited
Item
wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug
boolean
C1522449 (UMLS CUI [1,1])
C1882536 (UMLS CUI [1,2])
C0332464 (UMLS CUI [1,3])
C0475092 (UMLS CUI [2,1])
C1882536 (UMLS CUI [2,2])
C0439801 (UMLS CUI [2,3])
Heart Disease | Left ventricular ejection fraction | QTcF Prolongation | Angina, Unstable | Ventricular arrhythmia | Supraventricular arrhythmia | Nodal rhythm disorder
Item
active cardiac disease (e.g. lvef less than institutional lower limit of normal, qtcf > 480 msec, unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)
boolean
C0018799 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
C3828431 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0085612 (UMLS CUI [5])
C0428974 (UMLS CUI [6])
C0264893 (UMLS CUI [7])
Poor hypertension control
Item
inadequately controlled hypertension
boolean
C0421190 (UMLS CUI [1])
Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption BEZ235 | Gastrointestinal Disease Changing Absorption Paclitaxel
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of bez235 and/or paclitaxel
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C2347425 (UMLS CUI [2,4])
C0017178 (UMLS CUI [3,1])
C0392747 (UMLS CUI [3,2])
C0237442 (UMLS CUI [3,3])
C0144576 (UMLS CUI [3,4])
Pharmaceutical Preparations At risk Torsades de Pointes | CYP3A4 Inhibitors Moderate | CYP3A4 Inhibitors Strong | CYP3A4 Inducers Moderate | CYP3A4 Inducers Strong | Warfarin Analogue | Coumadin Analogue | Luteinizing Hormone-releasing Hormone Agonist
Item
treatment at start of study treatment with drugs with a known risk to induce torsades de pointes, moderate and strong inhibitors or inducers of isoenzyme cyp3a4, warfarin and coumadin analogues, lhrh agonists
boolean
C0013227 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C0040479 (UMLS CUI [1,3])
C3850053 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C3850053 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C3850041 (UMLS CUI [4,1])
C0205081 (UMLS CUI [4,2])
C3850041 (UMLS CUI [5,1])
C0442821 (UMLS CUI [5,2])
C0043031 (UMLS CUI [6,1])
C0243071 (UMLS CUI [6,2])
C0699129 (UMLS CUI [7,1])
C0243071 (UMLS CUI [7,2])
C1518041 (UMLS CUI [8])
Paclitaxel allergy
Item
sensitivity to paclitaxel treatment
boolean
C0570707 (UMLS CUI [1])
Diabetic - poor control
Item
uncontrolled diabetes mellitus
boolean
C0421258 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or nursing (lactating) woman
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Eligibility Criteria Additional
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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