Invasive carcinoma of breast | Recurrent disease Locally | Neoplasm Metastasis Radiology | Recurrent disease Inappropriate Excision Curative
Item
histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease. locally recurrent disease must not be amenable to resection with curative intent.
boolean
C0853879 (UMLS CUI [1])
C0277556 (UMLS CUI [2,1])
C1517927 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0043299 (UMLS CUI [3,2])
C0277556 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C0728940 (UMLS CUI [4,3])
C1276305 (UMLS CUI [4,4])
HER2/Neu Positive Immunohistochemistry | Staining method Positive | Fluorescent in situ hybridisation positive
Item
her2+ status defined as ihc 3+ staining or in situ hybridization positive
boolean
C2348909 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C0487602 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C3495875 (UMLS CUI [3])
Trastuzumab Resistance
Item
patients with resistance to trastuzumab
boolean
C0728747 (UMLS CUI [1,1])
C1514892 (UMLS CUI [1,2])
Taxane
Item
prior taxane therapy
boolean
C0215136 (UMLS CUI [1])
ECOG performance status
Item
patients with an ecog performance status of 0 - 2
boolean
C1520224 (UMLS CUI [1])
Measurable Disease
Item
patients with measurable disease as per recist criteria
boolean
C1513041 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative | Premenopausal state Sexually active Contraceptive methods | Estrogen Contraceptive Agents Excluded
Item
documentation of negative pregnancy test for patients of child bearing potential prior to enrollment within 7 days prior to randomization. sexually active pre-menopausal women must use adequate contraceptive measures, excluding estrogen containing contraceptives, while on study;
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009907 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Laboratory Criteria Fulfill
Item
patients must meet laboratory criteria defined in the study within 21 days prior to randomization
boolean
C0022877 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
mTOR Inhibitors Cancer treatment | Vinca Alkaloids Cancer treatment
Item
prior mtor inhibitors or vinca alkaloid agents for the treatment of cancer
boolean
C1515672 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
C0042672 (UMLS CUI [2,1])
C0920425 (UMLS CUI [2,2])
Chemotherapy Quantity Advanced disease
Item
more than three prior chemotherapy lines for advanced disease.
boolean
C0392920 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0679246 (UMLS CUI [1,3])
CNS metastases Symptomatic | Leptomeningeal disease
Item
symptomatic cns metastases or evidence of leptomeningeal disease. previously treated asymptomatic cns metastases are allowed provided that the last treatment for cns metastases was completed >8 weeks prior to randomization
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0751297 (UMLS CUI [2])
Gastrointestinal function Impaired | Gastrointestinal Disease Changing Absorption Everolimus Oral Product
Item
impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral everolimus
boolean
C0516983 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C3218081 (UMLS CUI [2,4])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy ≥ grade 2 at randomization
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Heart Disease
Item
active cardiac disease
boolean
C0018799 (UMLS CUI [1])
Cardiac dysfunction
Item
history of cardiac dysfunction
boolean
C3277906 (UMLS CUI [1])
Malignant Neoplasms | Exception Carcinoma in situ of uterine cervix Treated | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma Treated | Exception Skin carcinoma Treated
Item
any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0007117 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0007137 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0699893 (UMLS CUI [5,2])
C1522326 (UMLS CUI [5,3])
Hypersensitivity Investigational New Drugs
Item
known hypersensitivity to any study medication
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Breast Feeding | Pregnancy
Item
breastfeeding or pregnant
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may ap
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])