Eligible Everolimus | Eligible Exemestane
Item
eligible for everolimus+exemestane treatment as required by the marketing authorisation conditions
boolean
C1548635 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
Gender | Breast adenocarcinoma metastatic Estrogen receptor positive | Breast adenocarcinoma metastatic Progesterone receptor positive HER2 Negative | Advanced disease Locally | Operative Surgical Procedures Unsuccessful | Therapeutic radiology procedure Unsuccessful
Item
1. women (or men) with histologically-proven er+ and/or pr+ /her2- metastatic breast adenocarcinoma or locally advanced disease who cannot be treated with surgery and/or radiation therapy
boolean
C0079399 (UMLS CUI [1])
C1697918 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C1697918 (UMLS CUI [3,1])
C0279759 (UMLS CUI [3,2])
C2348908 (UMLS CUI [3,3])
C0679246 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
C0543467 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C1272705 (UMLS CUI [6,2])
Postmenopausal state
Item
2. postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Disease Visceral Asymptomatic
Item
3. asymptomatic if visceral disease
boolean
C0012634 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0231221 (UMLS CUI [1,3])
Second line Hormone Therapy Neoplasm Metastasis | Second line Hormone Therapy Advanced disease Locally | Status post Recurrence | Status post Disease Progression | Non-Steroidal Aromatase Inhibitor | Adjuvant therapy | Neoplasm Metastasis
Item
4. second line hormonotherapy or more for metastatic or locally advanced disease after recurrence or progression following a non-steroidal aromatase inhibitor (in adjuvant or metastatic setting)
boolean
C1710038 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1710038 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0034897 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C1518386 (UMLS CUI [5])
C0677850 (UMLS CUI [6])
C0027627 (UMLS CUI [7])
Eligible Biopsy
Item
eligible for the biopsy
boolean
C1548635 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Hormone Therapy Progressive Disease
Item
5. progressive disease under endocrine therapy at the time of inclusion
boolean
C0279025 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
Treatment Start Absent Everolimus | Treatment Start Absent Exemestane
Item
6. treatment with everolimus and exemestane not yet started
boolean
C0087111 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0541315 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0851344 (UMLS CUI [2,4])
Neoplasm Metastasis Biopsy | Exception Secondary malignant neoplasm of bone
Item
7. patients with metastases that can be biopsied, except bone metastases
boolean
C0027627 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease
Item
8. measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Age
Item
9. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
10. who performance status 0/1
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
11. provision of signed and dated, written informed consent prior to any protocol specific procedure, including biopsy
boolean
C0021430 (UMLS CUI [1])
Social insurance Coverage
Item
12. patient with social insurance coverage
boolean
C0037435 (UMLS CUI [1,1])
C0376629 (UMLS CUI [1,2])
Medical contraindication Everolimus | Medical contraindication Exemestane | mTOR Inhibitors | Chemotherapy Regime Quantity Neoplasm Metastasis | Life Expectancy | Compression of spinal cord | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Progressive | Exception Metastatic malignant neoplasm to brain Asymptomatic | Exception Metastatic malignant neoplasm to brain Treated | Exception Steroids Absent Stable
Item
1. contraindications for everolimus+exemestane treatment 2. previous treatment with an anti-mtor therapy 3. more than 1 previous line of chemotherapy in metastatic setting 4. life expectancy <3 months, 5. spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
boolean
C1301624 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
C1515672 (UMLS CUI [3])
C0392920 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0023671 (UMLS CUI [5])
C0037926 (UMLS CUI [6])
C0220650 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0220650 (UMLS CUI [8,1])
C0205329 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0220650 (UMLS CUI [9,2])
C0231221 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0220650 (UMLS CUI [10,2])
C1522326 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0038317 (UMLS CUI [11,2])
C0332197 (UMLS CUI [11,3])
C0205360 (UMLS CUI [11,4])
Function Hematopoietic Impairment | Organ Impairment
Item
6. haematopoietic function or organ impairment as shown by the following criteria:
boolean
C0031843 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0178784 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Neutrophil count
Item
polynuclear neutrophils < 1.5 x 109/l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelets < 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin < 90 g/l
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of liver Absent
Item
alat/asat > 2.5x uln in the absence of or > 5x uln in the presence of liver metastases
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Elevated total bilirubin
Item
bilirubin > 1.5xuln
boolean
C0741494 (UMLS CUI [1])
Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance ≤50 ml/min (measured or calculated by cockroft and gault formula)
boolean
C0373595 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum calcium increased | Phosphate increased | Abnormality of coagulation | Other medical condition Biopsy Contraindicated | Secondary malignant neoplasm of bone | Condition Study Subject Participation Status Unfavorable | Condition compromises Protocol Compliance
Item
calcium and phosphate > uln 7. abnormal coagulation or any other medical situation contraindicating biopsy 8. bone metastases when this is the only site of biopsiable disease 9. any condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
boolean
C0595928 (UMLS CUI [1])
C0860988 (UMLS CUI [2])
C1846821 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C1444657 (UMLS CUI [4,3])
C0153690 (UMLS CUI [5])
C0348080 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C3640815 (UMLS CUI [6,3])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Freedom Deprivation | Guardianship
Item
10. individuals deprived of liberty or placed under the authority of a tutor.
boolean
C0016694 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0870627 (UMLS CUI [2])