Locally advanced breast cancer Estrogen receptor positive | Secondary malignant neoplasm of female breast Estrogen receptor positive | Postmenopausal state | Disease Progression | Aromatase Inhibitors | Locally advanced breast cancer PIK3CA Gene Mutation | Secondary malignant neoplasm of female breast PIK3CA Gene Mutation
Item
patients with er-positive locally advanced breast cancer or metastatic breast cancer (mbc). postmenopausal women with locally advanced breast cancer or metastatic breast cancer whose disease has progressed during or after treatment with an aromatase inhibitor. part ii: postmenopausal women with locally advanced pik3ca-mutant breast cancer or pik3ca-mutant mbc that has progressed during or after treatment with an ai.
boolean
C3495949 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0242656 (UMLS CUI [4])
C0593802 (UMLS CUI [5])
C3495949 (UMLS CUI [6,1])
C3272694 (UMLS CUI [6,2])
C0346993 (UMLS CUI [7,1])
C3272694 (UMLS CUI [7,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of 0 or 1
boolean
C1520224 (UMLS CUI [1])
Measurable Disease | Bone Disease only
Item
patients must have measurable disease by recist v1.1 or bone-only disease
boolean
C1513041 (UMLS CUI [1])
C0005940 (UMLS CUI [2,1])
C0205171 (UMLS CUI [2,2])
Hematologic function | Organ function
Item
adequate hematologic and end-organ function
boolean
C0221130 (UMLS CUI [1])
C0678852 (UMLS CUI [2])
Disease Estrogen receptor positive | Disease HER2 Negative
Item
estrogen receptor-positive disease and her2-negative disease
boolean
C0012634 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0012634 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
Prior Therapy Advanced breast cancer | Prior Therapy Secondary malignant neoplasm of female breast | fulvestrant | PI3K Inhibitor | mTOR Inhibitors
Item
prior treatment with fulvestrant, pi3k inhibitor, or mtor inhibitor for advanced breast cancer or mbc
boolean
C1514463 (UMLS CUI [1,1])
C3495917 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
C0935916 (UMLS CUI [3])
C1519050 (UMLS CUI [4])
C1515672 (UMLS CUI [5])
Cytotoxic Chemotherapy Quantity | Recurrent disease | Progressive Disease | Hormone Therapy Quantity Secondary malignant neoplasm of female breast
Item
prior treatment with > one cytotoxic chemotherapy regimens or experienced recurrent or progressive disease on > two endocrine therapies for metastatic breast cancer
boolean
C0677881 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0277556 (UMLS CUI [2])
C1335499 (UMLS CUI [3])
C0279025 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0346993 (UMLS CUI [4,3])
Malabsorption Syndrome | Condition Interferes with Absorption Enteral
Item
history of malabsorption syndrome or other condition that would interfere with enteral absorption
boolean
C0024523 (UMLS CUI [1])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C1304890 (UMLS CUI [2,4])
Cardiac dysfunction | Pulmonary Dysfunction
Item
history of clinically significant cardiac or pulmonary dysfunction
boolean
C3277906 (UMLS CUI [1])
C1709770 (UMLS CUI [2])
Liver disease
Item
clinically significant history of liver disease
boolean
C0023895 (UMLS CUI [1])
Autoimmune Disease Uncontrolled | Inflammatory disorder
Item
active uncontrolled autoimmune disease or active inflammatory disease
boolean
C0004364 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C1290884 (UMLS CUI [2])
Immunocompromised patient
Item
immunocompromised status
boolean
C0085393 (UMLS CUI [1])
Hypercalcemia Symptomatic
Item
symptomatic hypercalcemia
boolean
C0020437 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Patient need for Steroid therapy chronic
Item
need for current chronic corticosteroid therapy
boolean
C0686904 (UMLS CUI [1,1])
C0149783 (UMLS CUI [1,2])
C0205191 (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])
CNS metastases Untreated | CNS metastases | Eligibility Criteria Additional
Item
known untreated or active central nervous system (cns) metastases other protocol-defined inclusion/exclusion criteria may apply.
boolean
C0686377 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0686377 (UMLS CUI [2])
C1516637 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])