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])
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])