Adult | Gender | Age | Secondary malignant neoplasm of female breast | Locally advanced breast cancer | Curative Surgery Unsuccessful | Therapeutic radiology procedure Curative Unsuccessful
Item
adult women (≥ 18 years of age) with metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy.
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0346993 (UMLS CUI [4])
C3495949 (UMLS CUI [5])
C1511562 (UMLS CUI [6,1])
C1272705 (UMLS CUI [6,2])
C1522449 (UMLS CUI [7,1])
C1276305 (UMLS CUI [7,2])
C1272705 (UMLS CUI [7,3])
Oestrogen receptor positive breast cancer
Item
histological or cytological confirmation of estrogen-receptor positive (er+) breast cancer
boolean
C2938924 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal women.
boolean
C0232970 (UMLS CUI [1])
Refractory Disease Non-Steroidal Aromatase Inhibitor
Item
disease refractory to non steroidal aromatase inhibitors (nsai),
boolean
C1514815 (UMLS CUI [1,1])
C1518386 (UMLS CUI [1,2])
Systemic therapy | Disease recurrence | Disease Progression
Item
radiological or clinical evidence of recurrence or progression on or after the last systemic therapy prior to randomization.
boolean
C1515119 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Measurable lesion Quantity | Bone lesion Associated with Absence of Measurable Disease
Item
patients must have at least one lesion that can be accurately measured or bone lesions in the absence of measurable disease as defined above.
boolean
C1513041 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0238792 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1513041 (UMLS CUI [2,4])
HER2 Overexpression
Item
her2-overexpressing patients
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
Non-Measurable Lesion only | Pleural effusion | Ascites | Exception Secondary malignant neoplasm of bone
Item
patients with only non-measurable lesions other than bone metastasis (e.g. pleural effusion, ascites etc.).
boolean
C1334988 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0032227 (UMLS CUI [2])
C0003962 (UMLS CUI [3])
C1705847 (UMLS CUI [4,1])
C0153690 (UMLS CUI [4,2])
Chemotherapy Quantity Advanced breast cancer
Item
patients who received more than one chemotherapy line for advanced breast cancer.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C3495917 (UMLS CUI [1,3])
exemestane | mTOR Inhibitor
Item
previous treatment with exemestane or mtor inhibitors.
boolean
C0851344 (UMLS CUI [1])
C2746052 (UMLS CUI [2])
Hypersensitivity mTOR Inhibitor | Hypersensitivity Sirolimus
Item
known hypersensitivity to mtor inhibitors, e.g. sirolimus (rapamycin).
boolean
C0020517 (UMLS CUI [1,1])
C2746052 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
radiotherapy within four weeks prior to randomization
boolean
C1522449 (UMLS CUI [1])
Hormone replacement therapy
Item
currently receiving hormone replacement therapy,
boolean
C0282402 (UMLS CUI [1])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])