Eligibility Metastatic Breast Cancer NCT02394496

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StudyEvent: Eligibility
1. Eligibility Metastatic Breast Cancer NCT02394496

Name

Typ

Description | Question | Decode (Coded Value)

Datatyp

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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

C3888504 (UMLS CUI [1,1])
C0021044 (UMLS CUI [1,2])
C3888504 (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])

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])

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Eligibility Metastatic Breast Cancer NCT02394496