ID

44573

Description

Overcoming Endocrine Resistance in Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02394496

Link

https://clinicaltrials.gov/show/NCT02394496

Keywords

Versions (2)
  1. 6/18/18 6/18/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

To request one please log in.

License

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT02394496

English

Eligibility Metastatic Breast Cancer NCT02394496

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. provision of written informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
2. histological/cytological confirmation of breast cancer
Description

Breast Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0678222
3. documented positive hormone receptor status (er+ve and/or pgr+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
Description

Estrogen receptor positive tumor | Neoplasm Metastasis Estrogen receptor positive | Progesterone receptor positive tumor | Neoplasm Metastasis Progesterone receptor positive

Data type

boolean

Alias
UMLS CUI [1]
C1562312
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0279754
UMLS CUI [3]
C1562928
UMLS CUI [4,1]
C0027627
UMLS CUI [4,2]
C0279759
4. postmenopausal women
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
5. confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
Description

Disease Progression | Status post Adjuvant therapy | Status post Therapeutic procedure Neoplasm Metastasis | Aromatase Inhibitors

Data type

boolean

Alias
UMLS CUI [1]
C0242656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0677850
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0087111
UMLS CUI [3,3]
C0027627
UMLS CUI [4]
C0593802
6. patients demonstrating prior response to ai therapy
Description

Aromatase Inhibitors | Disease Response Previous

Data type

boolean

Alias
UMLS CUI [1]
C0593802
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205156
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.
Description

Measurable Disease | Osteolytic lesion | Bone lesion Mixed | Bone lesion Sclerotic | Measurable Disease Absent

Data type

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C0302313
UMLS CUI [3,1]
C0238792
UMLS CUI [3,2]
C0205430
UMLS CUI [4,1]
C0238792
UMLS CUI [4,2]
C0334135
UMLS CUI [5,1]
C1513041
UMLS CUI [5,2]
C0332197
8. may have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
Description

Prior radiation therapy Primary tumor | Prior radiation therapy Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0677930
UMLS CUI [2,1]
C0279134
UMLS CUI [2,2]
C0027627
9. life expectancy of at least 8 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
10. who performance status 0, 1 or 2
Description

WHO performance status scale

Data type

boolean

Alias
UMLS CUI [1]
C1298650
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.
Description

Cancer Other | Disease Free of | Low Risk Recurrence

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0332296
UMLS CUI [3,1]
C3538919
UMLS CUI [3,2]
C2825055
12. are able to swallow and retain oral medication;
Description

Able to swallow Oral medication | Ability Retain Oral medication

Data type

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0175795
UMLS CUI [2,1]
C0085732
UMLS CUI [2,2]
C0333118
UMLS CUI [2,3]
C0175795
13. are able to complete all screening assessments as outlined in the protocol;
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
14. patients must have normal organ and marrow function
Description

Organ function | Bone Marrow function

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
15. left ventricular ejection fraction (lvef) within the institutional normal range
Description

Left ventricular ejection fraction Normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0205307
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. previous therapy with fulvestrant and/or lapatinib;
Description

fulvestrant | lapatinib

Data type

boolean

Alias
UMLS CUI [1]
C0935916
UMLS CUI [2]
C1506770
2. patients with her 2 overexpressing, either ihc 3+ or fish +;
Description

HER-2 protein overexpression Immunohistochemistry | HER-2 protein overexpression FISH

Data type

boolean

Alias
UMLS CUI [1,1]
C1515560
UMLS CUI [1,2]
C0021044
UMLS CUI [2,1]
C1515560
UMLS CUI [2,2]
C0162789
3. concurrent non study anti-cancer therapy (
Description

Clinical Trial Cancer treatment

Data type

boolean

Alias
UMLS CUI [1,1]
C0008976
UMLS CUI [1,2]
C0920425
4. have unresolved or unstable, serious toxicity from prior administration
Description

Toxicity Serious Without Resolution | Toxicity Serious Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0332288
UMLS CUI [1,4]
C1514893
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0205404
UMLS CUI [2,3]
C0443343
5. have malabsorption syndrome,
Description

Malabsorption Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0024523
6. have a concurrent disease or condition that would make the patient inappropriate for study participation,
Description

Comorbidity Study Subject Participation Status Inappropriate | Condition Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1548788
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C1548788
7. have an active or uncontrolled infection;
Description

Communicable Disease | Communicable Disease Uncontrolled

Data type

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205318
8. have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
Description

Dementia Informed Consent Excluded | Mental state altered Informed Consent Excluded | Mental condition Informed Consent Excluded

Data type

boolean

Alias
UMLS CUI [1,1]
C0497327
UMLS CUI [1,2]
C0021430
UMLS CUI [1,3]
C0332196
UMLS CUI [2,1]
C0278060
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0021430
UMLS CUI [2,4]
C0332196
UMLS CUI [3,1]
C3840291
UMLS CUI [3,2]
C0021430
UMLS CUI [3,3]
C0332196
9. have a known history of uncontrolled or symptomatic angina, arrhythmias, or chf;
Description

Angina Pectoris Uncontrolled | Angina Pectoris Symptomatic | Cardiac Arrhythmia Uncontrolled | ARRHYTHMIA SYMPTOMATIC | Congestive heart failure Uncontrolled | Symptomatic congestive heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0003811
UMLS CUI [3,2]
C0205318
UMLS CUI [4]
C0741212
UMLS CUI [5,1]
C0018802
UMLS CUI [5,2]
C0205318
UMLS CUI [6]
C0742758
10. receive concurrent treatment with an investigational agent or participate in another clinical trial;
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
11. receive concurrent treatment with prohibited medications
Description

Illicit Drugs Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0086190
UMLS CUI [1,2]
C0087111
12. used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
13. have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0013227
UMLS CUI [1,3]
C0935916
UMLS CUI [1,4]
C0439849
UMLS CUI [2,1]
C0231191
UMLS CUI [2,2]
C0013227
UMLS CUI [2,3]
C0935916
UMLS CUI [2,4]
C0439849
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C0013227
UMLS CUI [3,3]
C0593802
UMLS CUI [3,4]
C0439849
UMLS CUI [4,1]
C0231191
UMLS CUI [4,2]
C0013227
UMLS CUI [4,3]
C0593802
UMLS CUI [4,4]
C0439849
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0013227
UMLS CUI [5,3]
C1506770
UMLS CUI [5,4]
C0439849
UMLS CUI [6,1]
C0231191
UMLS CUI [6,2]
C0013227
UMLS CUI [6,3]
C1506770
UMLS CUI [6,4]
C0439849
UMLS CUI [7,1]
C0020517
UMLS CUI [7,2]
C0935916
UMLS CUI [7,3]
C0015237
UMLS CUI [8,1]
C0231191
UMLS CUI [8,2]
C0935916
UMLS CUI [8,3]
C0015237
UMLS CUI [9,1]
C0020517
UMLS CUI [9,2]
C0593802
UMLS CUI [9,3]
C0015237
UMLS CUI [10,1]
C0231191
UMLS CUI [10,2]
C0593802
UMLS CUI [10,3]
C0015237
UMLS CUI [11,1]
C0020517
UMLS CUI [11,2]
C1506770
UMLS CUI [11,3]
C0015237
UMLS CUI [12,1]
C0231191
UMLS CUI [12,2]
C1506770
UMLS CUI [12,3]
C0015237
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Similar models

Eligibility Metastatic Breast Cancer NCT02394496

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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])
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
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])
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