ID

30650

Description

A Study of PI3-Kinase Inhibitor GDC-0941 in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, in Patients With Locally Recurrent Or Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00960960

Link

https://clinicaltrials.gov/show/NCT00960960

Keywords

Versions (1)
  1. 6/19/18 6/19/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 19, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer, Locally Advanced Breast Cancer NCT00960960

English

Eligibility Metastatic Breast Cancer, Locally Advanced Breast Cancer NCT00960960

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
Description

Breast adenocarcinoma | Recurrent disease Local | Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1]
C0858252
UMLS CUI [2,1]
C0277556
UMLS CUI [2,2]
C0205276
UMLS CUI [3]
C0027627
adequate organ and bone marrow function as assessed by laboratory tests
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
Description

Evaluable Disease | Measurable Disease

Data type

boolean

Alias
UMLS CUI [1]
C1516986
UMLS CUI [2]
C1513041
agreement to use an effective form of contraception for the duration of the study
Description

Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of grade >/= 3 fasting hyperglycemia
Description

Fasting hyperglycaemia CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C2609269
UMLS CUI [1,2]
C1516728
history of diabetes requiring regular medication
Description

Diabetes Mellitus Requirement Pharmaceutical Preparations Regular

Data type

boolean

Alias
UMLS CUI [1,1]
C0011849
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
UMLS CUI [1,4]
C0205272
history of malabsorption syndrome or other condition that would interfere with enteral absorption
Description

Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral

Data type

boolean

Alias
UMLS CUI [1,1]
C0024523
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C1304890
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0237442
UMLS CUI [2,4]
C1304890
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
Description

Condition Requirement Anticoagulants | Warfarin | Heparin | Thrombolytic Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0003280
UMLS CUI [2]
C0043031
UMLS CUI [3]
C0019134
UMLS CUI [4]
C0016018
prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
Description

Cancer treatment Previous | Chemotherapy | Biological treatment | Hormone Therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0392920
UMLS CUI [3]
C1531518
UMLS CUI [4]
C0279025
uncontrolled current illness
Description

Illness Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0221423
UMLS CUI [1,2]
C0205318
active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
Description

Autoimmune Diseases | Requirement Equivalent Prednisone U/day

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0205163
UMLS CUI [2,3]
C0032952
UMLS CUI [2,4]
C0456683
clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hiv, hepatitis b virus, or hepatitis c virus
Description

Liver diseases | Liver Cirrhosis | Alcohol abuse | HIV Infection | Hepatitis B | Hepatitis C

Data type

boolean

Alias
UMLS CUI [1]
C0023895
UMLS CUI [2]
C0023890
UMLS CUI [3]
C0085762
UMLS CUI [4]
C0019693
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
known hiv infection
Description

HIV Infection

Data type

boolean

Alias
UMLS CUI [1]
C0019693
new york heart association (nyha) class ii or greater congestive heart failure
Description

Congestive heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018802
UMLS CUI [1,2]
C1275491
active ventricular arrhythmia requiring medication
Description

Ventricular arrhythmia Requirement Pharmaceutical Preparations

Data type

boolean

Alias
UMLS CUI [1,1]
C0085612
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0013227
pregnancy, lactation, or breastfeeding
Description

Pregnancy | Lactation | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0022925
UMLS CUI [3]
C0006147
known significant hypersensitivity to study drugs or excipients
Description

Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient

Data type

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]
C0015237
history of arterial thromboembolic disease within 6 months of first study treatment
Description

Thromboembolism Arterial

Data type

boolean

Alias
UMLS CUI [1,1]
C0040038
UMLS CUI [1,2]
C0221464
no more than two prior chemotherapy regimens for metastatic disease
Description

Chemotherapy Regimen Quantity Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0027627
no prior taxane therapy for metastatic disease
Description

Taxane Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0215136
UMLS CUI [1,2]
C0027627
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Similar models

Eligibility Metastatic Breast Cancer, Locally Advanced Breast Cancer NCT00960960

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast adenocarcinoma | Recurrent disease Local | Neoplasm Metastasis
Item
confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease
boolean
C0858252 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C0205276 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
Organ function | Bone Marrow function
Item
adequate organ and bone marrow function as assessed by laboratory tests
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Evaluable Disease | Measurable Disease
Item
evaluable disease or disease measurable per response evaluation criteria in solid tumors (recist)
boolean
C1516986 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Contraceptive methods
Item
agreement to use an effective form of contraception for the duration of the study
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Fasting hyperglycaemia CTCAE Grades
Item
history of grade >/= 3 fasting hyperglycemia
boolean
C2609269 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Diabetes Mellitus Requirement Pharmaceutical Preparations Regular
Item
history of diabetes requiring regular medication
boolean
C0011849 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0205272 (UMLS CUI [1,4])
Malabsorption Syndrome Interferes with Absorption Enteral | Condition Interferes with Absorption Enteral
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C1304890 (UMLS CUI [1,4])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Condition Requirement Anticoagulants | Warfarin | Heparin | Thrombolytic Agents
Item
any condition requiring full-dose anticoagulants, such as warfarin, heparin, or thrombolytic agents
boolean
C0348080 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0003280 (UMLS CUI [1,3])
C0043031 (UMLS CUI [2])
C0019134 (UMLS CUI [3])
C0016018 (UMLS CUI [4])
Cancer treatment Previous | Chemotherapy | Biological treatment | Hormone Therapy
Item
prior anti-cancer therapy (e.g., chemotherapy, biologic therapy, or hormonal therapy) within a specified timeframe of the first dose of study treatment
boolean
C0920425 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2])
C1531518 (UMLS CUI [3])
C0279025 (UMLS CUI [4])
Illness Uncontrolled
Item
uncontrolled current illness
boolean
C0221423 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Autoimmune Diseases | Requirement Equivalent Prednisone U/day
Item
active autoimmune disease requiring the equivalent of >10 mg/day of prednisone
boolean
C0004364 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C0032952 (UMLS CUI [2,3])
C0456683 (UMLS CUI [2,4])
Liver diseases | Liver Cirrhosis | Alcohol abuse | HIV Infection | Hepatitis B | Hepatitis C
Item
clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with hiv, hepatitis b virus, or hepatitis c virus
boolean
C0023895 (UMLS CUI [1])
C0023890 (UMLS CUI [2])
C0085762 (UMLS CUI [3])
C0019693 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
HIV Infection
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])
Congestive heart failure New York Heart Association Classification
Item
new york heart association (nyha) class ii or greater congestive heart failure
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Ventricular arrhythmia Requirement Pharmaceutical Preparations
Item
active ventricular arrhythmia requiring medication
boolean
C0085612 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
Pregnancy | Lactation | Breast Feeding
Item
pregnancy, lactation, or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0022925 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drugs Excipient
Item
known significant hypersensitivity to study drugs or excipients
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
Thromboembolism Arterial
Item
history of arterial thromboembolic disease within 6 months of first study treatment
boolean
C0040038 (UMLS CUI [1,1])
C0221464 (UMLS CUI [1,2])
Chemotherapy Regimen Quantity Neoplasm Metastasis
Item
no more than two prior chemotherapy regimens for metastatic disease
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Taxane Neoplasm Metastasis
Item
no prior taxane therapy for metastatic disease
boolean
C0215136 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
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