Age
Item
patients 18 years old or greater
boolean
C0001779 (UMLS CUI [1])
Secondary malignant neoplasm of female breast unresectable | Locally advanced breast cancer unresectable | Secondary malignant neoplasm of female breast Inappropriate Curative Surgery | Locally advanced breast cancer Inappropriate Curative Surgery | Secondary malignant neoplasm of female breast Inappropriate Therapeutic radiology procedure Curative | Locally advanced breast cancer Inappropriate Therapeutic radiology procedure Curative
Item
patients with metastatic or locally advanced, unresectable breast cancer not amenable to curative treatment by surgery or radiotherapy
boolean
C0346993 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C3495949 (UMLS CUI [2,1])
C1519810 (UMLS CUI [2,2])
C0346993 (UMLS CUI [3,1])
C1548788 (UMLS CUI [3,2])
C1511562 (UMLS CUI [3,3])
C3495949 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1511562 (UMLS CUI [4,3])
C0346993 (UMLS CUI [5,1])
C1548788 (UMLS CUI [5,2])
C1522449 (UMLS CUI [5,3])
C1276305 (UMLS CUI [5,4])
C3495949 (UMLS CUI [6,1])
C1548788 (UMLS CUI [6,2])
C1522449 (UMLS CUI [6,3])
C1276305 (UMLS CUI [6,4])
Breast Carcinoma Estrogen receptor positive HER2 Negative
Item
histological or cytological confirmation of estrogen-receptor positive (er+) human epidermal growth factor receptor 2 negative (her2-) breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C2348908 (UMLS CUI [1,3])
Postmenopausal state
Item
postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Prior Therapy Absent Secondary malignant neoplasm of female breast
Item
no prior treatment for metastatic breast cancer
boolean
C1514463 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
Non-Measurable Lesion | Exception Secondary malignant neoplasm of bone | Pleural effusion | Ascites
Item
patients with only non-measurable lesions other than bone metastases (e.g., pleural effusion, ascites, etc)
boolean
C1334988 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
C0032227 (UMLS CUI [3])
C0003962 (UMLS CUI [4])
Prior Hormone Therapy Secondary malignant neoplasm of female breast | Systemic therapy Secondary malignant neoplasm of female breast
Item
patients who have received prior hormonal or any other systemic therapy for metastatic breast cancer.
boolean
C1514460 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
C1515119 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Hormone Therapy Neoadjuvant allowed | Prior adjuvant endocrine therapy allowed | NSAID Neoadjuvant Treatment completed | NSAID Adjuvant Treatment completed | Letrozole Treatment completed | Anastrozole Treatment completed
Item
patients may have received prior neoadjuvant or adjuvant endocrine therapy. in the case of neoadjuvant or adjuvant nsai (letrozole/anastrozole) therapy patients must have completed therapy at least 1 year prior to study enrollment.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0281266 (UMLS CUI [2,1])
C0683607 (UMLS CUI [2,2])
C0003211 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0580352 (UMLS CUI [3,3])
C0003211 (UMLS CUI [4,1])
C1522673 (UMLS CUI [4,2])
C0580352 (UMLS CUI [4,3])
C0246421 (UMLS CUI [5,1])
C0580352 (UMLS CUI [5,2])
C0290883 (UMLS CUI [6,1])
C0580352 (UMLS CUI [6,2])
mTOR Inhibitors
Item
previous treatment with mtor inhibitors.
boolean
C1515672 (UMLS CUI [1])
Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus
Item
known hypersensitivity to mtor inhibitors, e.g., sirolimus (rapamycin).
boolean
C0020517 (UMLS CUI [1,1])
C1515672 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0072980 (UMLS CUI [2,2])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])