Informed Consent
Item
1. written informed consent to participate in the trial
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Oestrogen receptor positive breast cancer
Item
3. histologically confirmed er +ve breast cancer (allred ≥ 3)
boolean
C2938924 (UMLS CUI [1])
HER2 Status Any
Item
4. any her2 status
boolean
C1512413 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Neoplasm Longest Diameter Ultrasonography
Item
5. tumour measuring ≥ 15mm in longest diameter on ultrasound (us) examination
boolean
C0027651 (UMLS CUI [1,1])
C0552406 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,3])
Postmenopausal state
Item
6. postmenopausal women as defined by any one of the following criteria:
boolean
C0232970 (UMLS CUI [1])
Amenorrhea Duration | Uterus Intact
Item
amenorrhoea > 12 months at the time of diagnosis and an intact uterus or,
boolean
C0002453 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0042149 (UMLS CUI [2,1])
C0205266 (UMLS CUI [2,2])
Bilateral oophorectomy
Item
prior bilateral oophorectomy or,
boolean
C0278321 (UMLS CUI [1])
Follicle stimulating hormone measurement Consistent with Postmenopausal state | Gender | Age | Hysterectomy
Item
fsh levels within the postmenopausal range (as per local practice) in women aged < 55years who have undergone hysterectomy or,
boolean
C0202022 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
Follicle stimulating hormone measurement Consistent with Postmenopausal state | Gender | Age | Hormone replacement therapy
Item
fsh levels within the postmenopausal range (as per local practice) in women aged < 55 years who have been on hormone replacement therapy (hrt) within the last 12 months and are therefore not amenorrhoeic
boolean
C0202022 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0232970 (UMLS CUI [1,3])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0282402 (UMLS CUI [4])
ECOG performance status
Item
7. eastern cooperative oncology group (ecog) performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
Bone Marrow function | Hemoglobin measurement | White Blood Cell Count procedure | Platelet Count measurement | Renal function | Creatinine measurement, serum | Liver function | Serum total bilirubin measurement | Exception Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement | Alkaline phosphatase measurement
Item
8. adequate bone marrow function defined by hb ≥ 10 g/dl, wbc ≥ 3.0 x109, plt ≥ 100 x109/l. adequate renal function defined by a serum creatinine ≤ 1.5 x uln. adequate liver function defined by total bilirubin ≤ 1.5 uln (patients with gilbert's syndrome exempted), either alt or ast ≤ 1.5 uln and alp ≤ 1.5 uln
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0518015 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0232804 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0232741 (UMLS CUI [7])
C1278039 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0017551 (UMLS CUI [9,2])
C0201836 (UMLS CUI [10])
C0201899 (UMLS CUI [11])
C0201850 (UMLS CUI [12])
Locally advanced breast cancer Inoperable
Item
1. locally advanced/inoperable breast cancer
boolean
C3495949 (UMLS CUI [1,1])
C0205187 (UMLS CUI [1,2])
Neoplasm Metastasis
Item
2. clinical evidence of metastatic disease
boolean
C0027627 (UMLS CUI [1])
Diffuse tumor configuration | Inflammatory carcinoma
Item
3. diffuse or inflammatory tumours
boolean
C1276429 (UMLS CUI [1])
C0334385 (UMLS CUI [2])
Invasive cancer | Exception Basal cell carcinoma Treated | Exception Squamous cell carcinoma of skin Treated | Exception Carcinoma in situ of uterine cervix Treated
Item
4. any history of invasive malignancy within 5 years of starting study treatment (other than adequately treated basal cell carcinoma or squamous cell carcinoma of the skin and cervical carcinoma in situ)
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
Bleeding tendency | Activated Partial Thromboplastin Time measurement | Prothrombin time assay
Item
5. evidence of bleeding diathesis and ptt and pt ≤ 1.5 x upper limit of normal
boolean
C1458140 (UMLS CUI [1])
C0030605 (UMLS CUI [2])
C0033707 (UMLS CUI [3])
Hormone replacement therapy | Pharmaceutical Preparations Containing Estrogens | Supplements Containing Estrogens | Vaginal estrogens | Phytoestrogens
Item
6. concomitant use (defined as use within 4 weeks prior to entry) of hrt or any other oestrogen-containing medication or supplement (including vaginal oestrogens and phytoestrogens)
boolean
C0282402 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0014939 (UMLS CUI [2,3])
C0242295 (UMLS CUI [3,1])
C0332256 (UMLS CUI [3,2])
C0014939 (UMLS CUI [3,3])
C1875126 (UMLS CUI [4])
C0071011 (UMLS CUI [5])
Estrogen implants
Item
7. previous use of oestrogen implants at any time.
boolean
C0848157 (UMLS CUI [1])
Use of
Item
8. concomitant use of:
boolean
C1524063 (UMLS CUI [1])
Rifampin | CYP2C Inducer | CYP3A Inducers | Rifabutin | rifapentine | Carbamazepine | Phenobarbital | Phenytoin | ST. JOHN'S WORT EXTRACT
Item
rifampicin and other cyp2c and 3a inducers such as rifabutin, rifapentine, carbamazepine, phenobarbital, phenytoin and st. john's wort
boolean
C0035608 (UMLS CUI [1])
C0910126 (UMLS CUI [2,1])
C3898767 (UMLS CUI [2,2])
C3850044 (UMLS CUI [3])
C0140575 (UMLS CUI [4])
C0073372 (UMLS CUI [5])
C0006949 (UMLS CUI [6])
C0031412 (UMLS CUI [7])
C0031507 (UMLS CUI [8])
C0813171 (UMLS CUI [9])
Carbonic Anhydrase Inhibitors Systemic
Item
systemic carbonic anhydrase inhibitors
boolean
C0007036 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Criteria cardiac
Item
9. any of the following cardiac criteria:
boolean
C0243161 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
QTcF Resting mean | ECG Quantity
Item
mean resting corrected qt interval (qtcf) > 450 ms obtained from 3 electrocardiograms (ecgs)
boolean
C1882513 (UMLS CUI [1,1])
C0035253 (UMLS CUI [1,2])
C0444504 (UMLS CUI [1,3])
C0013798 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Resting ECG Changes Abnormal | ECG complete left bundle branch block | Complete atrioventricular block
Item
any clinically important abnormalities in rhythm, conduction or morphology of resting ecg e.g. complete left bundle branch block, third degree heart block
boolean
C3897699 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C4518442 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
Factor At risk Prolonged QTc interval | Factor At risk Cardiac Arrhythmia | Heart failure | Hypokalemia | Congenital long QT syndrome | Unexplained sudden death Relationship Age | Pharmaceutical Preparations Causing Prolonged QT interval
Item
any factors that increase the risk of qtc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long qt syndrome, family history of long qt syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the qt interval
boolean
C1521761 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1560305 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C0003811 (UMLS CUI [2,3])
C0018801 (UMLS CUI [3])
C0020621 (UMLS CUI [4])
C1141890 (UMLS CUI [5])
C0520806 (UMLS CUI [6,1])
C0439849 (UMLS CUI [6,2])
C0001779 (UMLS CUI [6,3])
C0013227 (UMLS CUI [7,1])
C0678227 (UMLS CUI [7,2])
C0151878 (UMLS CUI [7,3])
Abnormality Uncontrolled Serum potassium measurement | Abnormality Uncontrolled Sodium measurement | Abnormality Uncontrolled Calcium measurement | Abnormality Uncontrolled Magnesium measurement
Item
10. uncontrolled abnormalities of serum potassium, sodium, calcium or magnesium levels
boolean
C1704258 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0302353 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0337443 (UMLS CUI [2,3])
C1704258 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0201925 (UMLS CUI [3,3])
C1704258 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0373675 (UMLS CUI [4,3])
Communicable Disease Uncontrolled
Item
11. evidence of uncontrolled active infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Medical condition Study Subject Participation Status Unfavorable | Laboratory test finding Study Subject Participation Status Unfavorable
Item
12. evidence of significant medical condition or laboratory finding which, in the opinion of the investigator, makes it undesirable for the patient to participate in the trial
boolean
C3843040 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C3640815 (UMLS CUI [1,3])
C0587081 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C3640815 (UMLS CUI [2,3])
ID.30
Item
13. subjects unable to lie flat or fit into the scanner
boolean
ID.31
Item
14. patients on occupational monitoring for radiation exposure
boolean