Age | Gender | Secondary malignant neoplasm of female breast
Item
1. >18 years old women with metastatic breast cancer
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0346993 (UMLS CUI [3])
Hormone receptor positive malignant neoplasm of breast | Estrogen receptor positive Percentage | Progesterone receptor positive Percentage | HER2 Negative Immunohistochemistry | HER2 Negative FISH
Item
2. histological confirmation of hormone-receptor positive (defined as at least 10% of estrogen receptor (er) and/or progesterone receptor (pgr) positivity) and human epidermal growth factor receptor 2 (her2) negative (score 0-1+ in immunohistochemistry or fish negativity) breast cancer
boolean
C1562029 (UMLS CUI [1])
C0279754 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0279759 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
C2348908 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
C2348908 (UMLS CUI [5,1])
C0162789 (UMLS CUI [5,2])
Postmenopausal state
Item
3. postmenopausal status
boolean
C0232970 (UMLS CUI [1])
Line of Chemotherapy Quantity Neoplasm Metastasis | Chemotherapy cycle Quantity Minimum | Disease Controlled | In complete remission | Partial response | Stable Disease
Item
4. one line of chemotherapy for metastatic disease; patients must have received a minimum of 6 cycles of chemotherapy in order to be eligible, and must have obtained disease control (cr or pr od sd)
boolean
C4524693 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,4])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
C2911690 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
C1521726 (UMLS CUI [5])
C0677946 (UMLS CUI [6])
ECOG performance status
Item
5. eastern cooperative oncology group (ecog) performance status < 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow Function | Blood coagulation Function
Item
6. adequate bone marrow and coagulation function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0005778 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Liver function
Item
7. adequate liver function
boolean
C0232741 (UMLS CUI [1])
Renal function
Item
8. adequate renal function
boolean
C0232804 (UMLS CUI [1])
Fasting cholesterol level | Serum fasting triglyceride measurement
Item
9. fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/l and fasting triglycerides ≤ 2.5
boolean
C1282513 (UMLS CUI [1])
C0582824 (UMLS CUI [2])
Upper Limit of Normal Out of range Statin therapy | Upper Limit of Normal Out of range Hypolipidemic Agents | Fibrates
Item
× upper limit of normal (uln). in case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy or other lipid lowering drugs (eg fibrates), and when the above mentioned values have been achieved
boolean
C1519815 (UMLS CUI [1,1])
C3845292 (UMLS CUI [1,2])
C1278454 (UMLS CUI [1,3])
C1519815 (UMLS CUI [2,1])
C3845292 (UMLS CUI [2,2])
C0086440 (UMLS CUI [2,3])
C1449704 (UMLS CUI [3])
Glucose measurement, fasting
Item
10. fasting glucose < 1.5 × uln
boolean
C0202045 (UMLS CUI [1])
Informed Consent
Item
11. written informed consent obtained before any screening procedure and according to local guidelines.
boolean
C0021430 (UMLS CUI [1])
HER2 Protein Overexpression Immunohistochemistry
Item
1. her2-overexpressing patients by local laboratory testing (immunohistochemistry 3+
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
HER2 Protein Overexpression Staining | HER2 Protein Overexpression In Situ Hybridization
Item
staining or in situ hybridization positive)
boolean
C1515560 (UMLS CUI [1,1])
C0487602 (UMLS CUI [1,2])
C1515560 (UMLS CUI [2,1])
C0162788 (UMLS CUI [2,2])
mTOR Inhibitors
Item
2. previous treatment with mammalian target of rapamycin (mtor) inhibitors
boolean
C1515672 (UMLS CUI [1])
Hypersensitivity mTOR Inhibitors | Hypersensitivity Sirolimus
Item
3. 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])
Line of Chemotherapy Quantity Neoplasm Metastasis
Item
4. more than one chemotherapy line for metastatic disease
boolean
C4524693 (UMLS CUI [1,1])
C3665472 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0027627 (UMLS CUI [1,4])
Compound Angiogenic Maintenance therapy | bevacizumab
Item
5. treatment with angiogenetic compounds as maintenance therapy (eg. bevacizumab)
boolean
C1706082 (UMLS CUI [1,1])
C0302600 (UMLS CUI [1,2])
C0677908 (UMLS CUI [1,3])
C0796392 (UMLS CUI [2])
Therapeutic radiology procedure | Toxicity due to radiotherapy Patient recovered
Item
6. radiotherapy within four weeks prior to enrollment except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. patients must have recovered from radiotherapy toxicities prior to enrollment
boolean
C1522449 (UMLS CUI [1])
C1302210 (UMLS CUI [2,1])
C1115804 (UMLS CUI [2,2])
CNS metastases Symptomatic
Item
7. symptomatic central nervous system metastases
boolean
C0686377 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
HIV Seropositivity
Item
8. patients with a known history of hiv positivity
boolean
C0019699 (UMLS CUI [1])
Bleeding tendency | Vitamin K Antagonist Oral | Exception Warfarin Low dose | Exception Aspirin Low Dose | Exception Equivalent | Relationship International Normalized Ratio
Item
9. active, bleeding diathesis, or on oral anti-vitamin k medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the international normalized ratio (inr) is ≤ 2.0)
boolean
C1458140 (UMLS CUI [1])
C2267235 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0043031 (UMLS CUI [3,2])
C0445550 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C2608320 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0205163 (UMLS CUI [5,2])
C0439849 (UMLS CUI [6,1])
C0525032 (UMLS CUI [6,2])
Medical condition Severe | Medical condition Uncontrolled
Item
10. any severe and / or uncontrolled medical conditions such as:
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3843040 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Angina, Unstable | Symptomatic congestive heart failure | Myocardial Infarction | Cardiac Arrhythmia Uncontrolled
Item
unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
boolean
C0002965 (UMLS CUI [1])
C0742758 (UMLS CUI [2])
C0027051 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
DIABETES MELLITUS UNCONTROLLED | Serum fasting glucose measurement
Item
uncontrolled diabetes as defined by fasting serum glucose > 1.5 × uln
boolean
C0743131 (UMLS CUI [1])
C0583334 (UMLS CUI [2])
Communicable Diseases | Chronic infectious disease | Illness Non-Malignant Uncontrolled | Complications Due to Investigational Therapy
Item
acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0221423 (UMLS CUI [3,1])
C1518371 (UMLS CUI [3,2])
C0205318 (UMLS CUI [3,3])
C0009566 (UMLS CUI [4,1])
C0678226 (UMLS CUI [4,2])
C0949266 (UMLS CUI [4,3])
Abnormal digestive tract function | Gastrointestinal Disease Changing Absorption Investigational New Drugs | Ulcer | Nausea Uncontrolled | Vomiting | Diarrhea | Malabsorption Syndrome
Item
impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome)
boolean
C0232459 (UMLS CUI [1])
C0017178 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0237442 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])
C0041582 (UMLS CUI [3])
C0027497 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0042963 (UMLS CUI [5])
C0011991 (UMLS CUI [6])
C0024523 (UMLS CUI [7])
Deterioration of lung function Symptomatic | Indication Pulmonary function tests | Indication Lung Volume Measurements predicted | Carbon Monoxide Diffusing Capability Test | Oxygen saturation measurement At rest On room air | Restrictive pulmonary disease Excluded | Pneumonitis Excluded | Pulmonary Infiltrates Excluded
Item
significant symptomatic deterioration of lung function. if clinically indicated, pulmonary function tests including measures of predicted lung volumes, diffusion capacity of lung for carbon monoxide (dlco) and o2 saturation at rest on room air should be considered to exclude restrictive pulmonary disease, pneumonitis or pulmonary infiltrates.
boolean
C4014536 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C0024119 (UMLS CUI [2,2])
C3146298 (UMLS CUI [3,1])
C0024129 (UMLS CUI [3,2])
C0681842 (UMLS CUI [3,3])
C1516251 (UMLS CUI [4])
C0523807 (UMLS CUI [5,1])
C0443144 (UMLS CUI [5,2])
C2709070 (UMLS CUI [5,3])
C0877013 (UMLS CUI [6,1])
C0332196 (UMLS CUI [6,2])
C3714636 (UMLS CUI [7,1])
C0332196 (UMLS CUI [7,2])
C0235896 (UMLS CUI [8,1])
C0332196 (UMLS CUI [8,2])
Hepatitis B positive | Hepatitis C positive
Item
11. patients who test positive for hepatitis b or c (patients who test negative for hepatitis b virus (hbv)-dna, hbsag, and hbcab but positive for hbsab with prior history of vaccination against hepatitis b will be eligible)
boolean
C0856706 (UMLS CUI [1])
C1112419 (UMLS CUI [2])
CYP3A Inhibitors Strong | CYP3A Inducers Strong | Rifabutin | Rifampin | Clarithromycin | Ketoconazole | Itraconazole | voriconazole | Ritonavir | telithromycin
Item
12. patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cytochrome p3a (rifabutin, rifampicin, clarithromycin, ketoconazole, itraconazole, voriconazole, ritonavir, telithromycin) within the last 5 days prior to enrollment
boolean
C3850056 (UMLS CUI [1,1])
C0442821 (UMLS CUI [1,2])
C3850044 (UMLS CUI [2,1])
C0442821 (UMLS CUI [2,2])
C0140575 (UMLS CUI [3])
C0035608 (UMLS CUI [4])
C0055856 (UMLS CUI [5])
C0022625 (UMLS CUI [6])
C0064113 (UMLS CUI [7])
C0393080 (UMLS CUI [8])
C0292818 (UMLS CUI [9])
C0907410 (UMLS CUI [10])
Compliance Lacking Therapy
Item
13. history of non-compliance to medical regimens
boolean
C1321605 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
14. patients unwilling to or unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])