Locally advanced breast cancer | Secondary malignant neoplasm of female breast
Item
locally advanced or metastatic breast cancer
boolean
C3495949 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
HER2 Negative | Hormone Receptor Positive | Breast Carcinoma Classification Tests
Item
her2-negative and hormone receptor-positive status (common breast cancer classification tests)
boolean
C2348908 (UMLS CUI [1])
C0019929 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0678222 (UMLS CUI [3,1])
C0008902 (UMLS CUI [3,2])
C0392366 (UMLS CUI [3,3])
Postmenopausal state
Item
postmenopausal woman
boolean
C0232970 (UMLS CUI [1])
Availability of Tumor tissue sample | Biomarker Identification | PI-3K Activation
Item
a tumor sample must be shipped to a novartis designated laboratory for identification of biomarkers (pi3k activation status)
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0005516 (UMLS CUI [2,1])
C0205396 (UMLS CUI [2,2])
C2936824 (UMLS CUI [3,1])
C1879547 (UMLS CUI [3,2])
Progression Breast Carcinoma | Breast cancer recurrent | Aromatase Inhibitors
Item
progression or recurrence of breast cancer while on or after aromatase inhibitor treatment
boolean
C0449258 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0278493 (UMLS CUI [2])
C0593802 (UMLS CUI [3])
Measurable Disease | Non-Measurable Lesion | Bone lesion Measurable Disease Absent
Item
measurable disease or non measurable disease bone lesions in the absence of measurable disease as per recist 1.1
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
C0238792 (UMLS CUI [3,1])
C1513041 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Bone Marrow function Definition Laboratory Results | Organ function Definition Laboratory Results
Item
adequate bone marrow and organ function defined by laboratory values
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C1704788 (UMLS CUI [1,3])
C1254595 (UMLS CUI [1,4])
C0678852 (UMLS CUI [2,1])
C1704788 (UMLS CUI [2,2])
C1254595 (UMLS CUI [2,3])
Prior Therapy | PI3K Inhibitor | AKT inhibitors | mTOR Inhibitors | fulvestrant
Item
previous treatment with pi3k inhibitors, akt inhibitors, mtor inhibitor or fulvestrant
boolean
C1514463 (UMLS CUI [1])
C1519050 (UMLS CUI [2])
C0812228 (UMLS CUI [3,1])
C0243077 (UMLS CUI [3,2])
C1515672 (UMLS CUI [4])
C0935916 (UMLS CUI [5])
Prior Chemotherapy Quantity Neoplasm Metastasis
Item
more than one prior chemotherapy line for metastatic disease
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Metastatic malignant neoplasm to brain Symptomatic
Item
symptomatic brain metastases
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Adrenal Cortex Hormones Increasing | Adrenal Cortex Hormones chronic | Immunosuppressive Agents Increasing | Immunosuppressive Agents chronic
Item
increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
boolean
C0001617 (UMLS CUI [1,1])
C0442808 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0021081 (UMLS CUI [3,1])
C0442808 (UMLS CUI [3,2])
C0021081 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
Heart Disease
Item
active heart (cardiac) disease as defined in the protocol
boolean
C0018799 (UMLS CUI [1])
Anxiety Questionnaire Score | Depressed mood Questionnaire Score
Item
certain scores on an anxiety and depression mood questionnaires
boolean
C0003467 (UMLS CUI [1,1])
C0034394 (UMLS CUI [1,2])
C0449820 (UMLS CUI [1,3])
C0344315 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0449820 (UMLS CUI [2,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])