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])