Informed Consent
Item
1. provision of written informed consent
boolean
C0021430 (UMLS CUI [1])
Breast Carcinoma
Item
2. histological/cytological confirmation of breast cancer
boolean
C0678222 (UMLS CUI [1])
Estrogen receptor positive tumor | Neoplasm Metastasis Estrogen receptor positive | Progesterone receptor positive tumor | Neoplasm Metastasis Progesterone receptor positive
Item
3. documented positive hormone receptor status (er+ve and/or pgr+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
boolean
C1562312 (UMLS CUI [1])
C0027627 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C1562928 (UMLS CUI [3])
C0027627 (UMLS CUI [4,1])
C0279759 (UMLS CUI [4,2])
Postmenopausal state
Item
4. postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Disease Progression | Status post Adjuvant therapy | Status post Therapeutic procedure Neoplasm Metastasis | Aromatase Inhibitors
Item
5. confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
boolean
C0242656 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C0027627 (UMLS CUI [3,3])
C0593802 (UMLS CUI [4])
Aromatase Inhibitors | Disease Response Previous
Item
6. patients demonstrating prior response to ai therapy
boolean
C0593802 (UMLS CUI [1])
C1704632 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Measurable Disease | Osteolytic lesion | Bone lesion Mixed | Bone lesion Sclerotic | Measurable Disease Absent
Item
7. patients with measurable disease as per recist criteria /patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by recist criteria.
boolean
C1513041 (UMLS CUI [1])
C0302313 (UMLS CUI [2])
C0238792 (UMLS CUI [3,1])
C0205430 (UMLS CUI [3,2])
C0238792 (UMLS CUI [4,1])
C0334135 (UMLS CUI [4,2])
C1513041 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
Prior radiation therapy Primary tumor | Prior radiation therapy Neoplasm Metastasis
Item
8. may have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
boolean
C0279134 (UMLS CUI [1,1])
C0677930 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
Life Expectancy
Item
9. life expectancy of at least 8 months
boolean
C0023671 (UMLS CUI [1])
WHO performance status scale
Item
10. who performance status 0, 1 or 2
boolean
C1298650 (UMLS CUI [1])
Cancer Other | Disease Free of | Low Risk Recurrence
Item
11. patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence.
boolean
C1707251 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
C3538919 (UMLS CUI [3,1])
C2825055 (UMLS CUI [3,2])
Able to swallow Oral medication | Ability Retain Oral medication
Item
12. are able to swallow and retain oral medication;
boolean
C2712086 (UMLS CUI [1,1])
C0175795 (UMLS CUI [1,2])
C0085732 (UMLS CUI [2,1])
C0333118 (UMLS CUI [2,2])
C0175795 (UMLS CUI [2,3])
Protocol Compliance
Item
13. are able to complete all screening assessments as outlined in the protocol;
boolean
C0525058 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
14. patients must have normal organ and marrow function
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Left ventricular ejection fraction Normal
Item
15. left ventricular ejection fraction (lvef) within the institutional normal range
boolean
C0428772 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
fulvestrant | lapatinib
Item
1. previous therapy with fulvestrant and/or lapatinib;
boolean
C0935916 (UMLS CUI [1])
C1506770 (UMLS CUI [2])
HER-2 protein overexpression Immunohistochemistry | HER-2 protein overexpression FISH
Item
2. patients with her 2 overexpressing, either ihc 3+ or fish +;
boolean
C1515560 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C1515560 (UMLS CUI [2,1])
C0162789 (UMLS CUI [2,2])
Clinical Trial Cancer treatment
Item
3. concurrent non study anti-cancer therapy (
boolean
C0008976 (UMLS CUI [1,1])
C0920425 (UMLS CUI [1,2])
Toxicity Serious Without Resolution | Toxicity Serious Unstable
Item
4. have unresolved or unstable, serious toxicity from prior administration
boolean
C0600688 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0332288 (UMLS CUI [1,3])
C1514893 (UMLS CUI [1,4])
C0600688 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0443343 (UMLS CUI [2,3])
Malabsorption Syndrome
Item
5. have malabsorption syndrome,
boolean
C0024523 (UMLS CUI [1])
Comorbidity Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate
Item
6. have a concurrent disease or condition that would make the patient inappropriate for study participation,
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1548788 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
Communicable Disease | Communicable Disease Uncontrolled
Item
7. have an active or uncontrolled infection;
boolean
C0009450 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
Dementia Informed Consent Excluded | Mental state altered Informed Consent Excluded | Mental condition Informed Consent Excluded
Item
8. have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
boolean
C0497327 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0278060 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
C3840291 (UMLS CUI [3,1])
C0021430 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure Uncontrolled | Symptomatic congestive heart failure
Item
9. have a known history of uncontrolled or symptomatic angina, arrhythmias, or chf;
boolean
C0002962 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0003811 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0741212 (UMLS CUI [4])
C0018802 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0742758 (UMLS CUI [6])
Study Subject Participation Status | Investigational New Drugs
Item
10. receive concurrent treatment with an investigational agent or participate in another clinical trial;
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Illicit Drugs Therapeutic procedure
Item
11. receive concurrent treatment with prohibited medications
boolean
C0086190 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
Investigational New Drugs
Item
12. used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
boolean
C0013230 (UMLS CUI [1])
Hypersensitivity Pharmaceutical Preparations Fulvestrant Related | Idiosyncrasy Pharmaceutical Preparations Fulvestrant Related | Hypersensitivity Pharmaceutical Preparations Aromatase Inhibitors Related | Idiosyncrasy Pharmaceutical Preparations Aromatase Inhibitors Related | Hypersensitivity Pharmaceutical Preparations Lapatinib Related | Idiosyncrasy Pharmaceutical Preparations Lapatinib Related | Hypersensitivity Fulvestrant Excipient | Idiosyncrasy Fulvestrant Excipient | Hypersensitivity Aromatase Inhibitors Excipient | Idiosyncrasy Aromatase Inhibitors Excipient | Hypersensitivity Lapatinib Excipient | Idiosyncrasy Lapatinib Excipient
Item
13. have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.
boolean
C0020517 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0935916 (UMLS CUI [1,3])
C0439849 (UMLS CUI [1,4])
C0231191 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
C0935916 (UMLS CUI [2,3])
C0439849 (UMLS CUI [2,4])
C0020517 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
C0593802 (UMLS CUI [3,3])
C0439849 (UMLS CUI [3,4])
C0231191 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C0593802 (UMLS CUI [4,3])
C0439849 (UMLS CUI [4,4])
C0020517 (UMLS CUI [5,1])
C0013227 (UMLS CUI [5,2])
C1506770 (UMLS CUI [5,3])
C0439849 (UMLS CUI [5,4])
C0231191 (UMLS CUI [6,1])
C0013227 (UMLS CUI [6,2])
C1506770 (UMLS CUI [6,3])
C0439849 (UMLS CUI [6,4])
C0020517 (UMLS CUI [7,1])
C0935916 (UMLS CUI [7,2])
C0015237 (UMLS CUI [7,3])
C0231191 (UMLS CUI [8,1])
C0935916 (UMLS CUI [8,2])
C0015237 (UMLS CUI [8,3])
C0020517 (UMLS CUI [9,1])
C0593802 (UMLS CUI [9,2])
C0015237 (UMLS CUI [9,3])
C0231191 (UMLS CUI [10,1])
C0593802 (UMLS CUI [10,2])
C0015237 (UMLS CUI [10,3])
C0020517 (UMLS CUI [11,1])
C1506770 (UMLS CUI [11,2])
C0015237 (UMLS CUI [11,3])
C0231191 (UMLS CUI [12,1])
C1506770 (UMLS CUI [12,2])
C0015237 (UMLS CUI [12,3])