ID

35867

Description

Hydroxychloroquine in Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Hormonal Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02414776

Link

https://clinicaltrials.gov/show/NCT02414776

Keywords

Versions (1)
  1. 3/30/19 3/30/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 30, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Estrogen Receptor Positive Breast Cancer NCT02414776

English

Eligibility Estrogen Receptor Positive Breast Cancer NCT02414776

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients ≥ 18 years of age with histologically confirmed, metastatic er + breast cancer with clinical progression of disease (including radiographically stable disease with at least 50% increment of an elevated tumor marker by two measurements at least 2 weeks apart (this particular tumor marker will be used for disease status assessment in the study) on current hormonal therapy with pfs for at least 3 months.
Description

Age | Secondary malignant neoplasm of female breast Estrogen receptor positive | Disease Progression | Stable Disease Radiography | TUMOR MARKER LEVEL ELEVATED | Hormone Therapy | Progression-Free Survival

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0346993
UMLS CUI [2,2]
C0279754
UMLS CUI [3]
C0242656
UMLS CUI [4,1]
C0677946
UMLS CUI [4,2]
C0034571
UMLS CUI [5]
C0749735
UMLS CUI [6]
C0279025
UMLS CUI [7]
C0242792
2. karnofsky performance status (kps) ≥70% and a life expectancy >3 months.
Description

Karnofsky Performance Status | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0206065
UMLS CUI [2]
C0023671
3. participants must have at least one target visceral lesion that allows for evaluation of tumor response or in the case of bone-only metastases, patients need to have a positive imaging study such as bone scan, magnetic resonance imaging (mri) or positron emission tomography-computed tomography (pet-ct) or ct, and an elevated tumor marker at least twice as high as upper limit.
Description

Target Lesion Visceral Quantity | Evaluation Tumor Response | Secondary malignant neoplasm of bone Imaging study Positive | Bone scan | Magnetic Resonance Imaging | PET/CT scan | CT | Tumour marker increased

Data type

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0027651
UMLS CUI [2,3]
C1704632
UMLS CUI [3,1]
C0153690
UMLS CUI [3,2]
C1881134
UMLS CUI [3,3]
C1514241
UMLS CUI [4]
C0203668
UMLS CUI [5]
C0024485
UMLS CUI [6]
C1699633
UMLS CUI [7]
C0040405
UMLS CUI [8]
C0876999
4. absolute neutrophil count > 1500 mm3, platelet count ≥ 80×109 l, hemoglobin ≥ 8.5 g/dl
Description

Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0518015
5. creatinine clearance ≥ 30 ml/min, total bilirubin ≤ 2 mg/dl, ast/alt ≤ 3 times the upper limit of normal range
Description

Creatinine clearance measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
6. no remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the principal investigator
Description

Absence Toxicity Remaining CTCAE Grades | Cancer treatment Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0332197
UMLS CUI [1,2]
C0600688
UMLS CUI [1,3]
C1527428
UMLS CUI [1,4]
C1516728
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205156
7. at least two (2) weeks from prior major surgery
Description

Major surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
8. willingness to provide permission to biopsy one of the lesions if applicable before the study (all the patients are encouraged to have post-therapy biopsy upon progression of disease, but it is optional) as well as blood samples for pertinent laboratory studies
Description

Permission Biopsy lesion | Permission Collection of blood specimen for laboratory procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0521104
UMLS CUI [1,2]
C0940828
UMLS CUI [2,1]
C0521104
UMLS CUI [2,2]
C0005834
9. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable non-hormonal contraceptive method (abstinence, or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial -
Description

Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization | Sexual Abstinence | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2]
C0232969
UMLS CUI [3]
C0015787
UMLS CUI [4]
C0036899
UMLS CUI [5,1]
C0004764
UMLS CUI [5,2]
C0205173
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430057
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430061
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. on combination hormonal therapy with everolimus or any other investigational agent
Description

Combined Modality Therapy | Hormone Therapy | everolimus | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0009429
UMLS CUI [2]
C0279025
UMLS CUI [3]
C0541315
UMLS CUI [4]
C0013230
2. patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid 18jul2014 protocol v3: abc 01 anti-autophagy for met breast cancer page 4 of 16
Description

Metastatic malignant neoplasm to brain Symptomatic Untreated | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic Untreated | Metastatic malignant neoplasm to brain Symptomatic Treated | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic Treated | Steroids Required

Data type

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0332155
UMLS CUI [2,1]
C1704231
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0332155
UMLS CUI [3,1]
C0220650
UMLS CUI [3,2]
C0231220
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1704231
UMLS CUI [4,2]
C0231220
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C0038317
UMLS CUI [5,2]
C1514873
3. lymphangitic carcinomatosis involving ≥ 50% of the lungs; evidence of metastases involving more than one third of the liver on sonogram or computed tomography
Description

Lymphangitis carcinomatosa Involving Lung Percentage | Neoplasm Metastasis Involving Liver Third | Ultrasonography | Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0238258
UMLS CUI [1,2]
C1314939
UMLS CUI [1,3]
C0024109
UMLS CUI [1,4]
C0439165
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C1314939
UMLS CUI [2,3]
C0023884
UMLS CUI [2,4]
C0442047
UMLS CUI [3]
C0041618
UMLS CUI [4]
C0040405
4. lactating females
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
5. uncontrolled cardiac disease, congestive heart failure, angina or hypertension
Description

Heart Disease Uncontrolled | Congestive heart failure | Angina Pectoris | Hypertensive disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0018802
UMLS CUI [3]
C0002962
UMLS CUI [4]
C0020538
6. myocardial infarction or unstable angina within 2 months of treatment
Description

Myocardial Infarction | Angina, Unstable

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
7. known human immunodeficiency virus (hiv) infection or chronic active hepatitis b or c (patients are not required to be tested for the presence of such viruses prior to therapy on this protocol)
Description

HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2]
C0524909
UMLS CUI [3]
C0524910
8. active clinically serious infection > ctcae (version 4.03) grade 2
Description

Communicable Disease Serious CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C1516728
9. serious non-healing wound, ulcer, or bone fracture
Description

Wound, non-healed | Ulcer | Fracture

Data type

boolean

Alias
UMLS CUI [1]
C0750433
UMLS CUI [2]
C0041582
UMLS CUI [3]
C0016658
10. concurrent psychiatric illness/social situations that would limit safety and compliance with study requirements
Description

Mental disorders Limiting Safety | Mental disorders Limiting Protocol Compliance | Social situation Limiting Safety | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0036043
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0439801
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0748872
UMLS CUI [3,2]
C0439801
UMLS CUI [3,3]
C0036043
UMLS CUI [4,1]
C0748872
UMLS CUI [4,2]
C0439801
UMLS CUI [4,3]
C0525058
11. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
Description

Informed Consent Unable | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
12. currently receiving any other investigational therapeutic agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
13. patients with known glucose-6-phosphate dehydrogenase deficiency, porphyria, cirrhosis or any other conditions with potential significant known risks
Description

Deficiency of glucose-6-phosphate dehydrogenase | Porphyria | Liver Cirrhosis | Condition At risk

Data type

boolean

Alias
UMLS CUI [1]
C2939465
UMLS CUI [2]
C3463940
UMLS CUI [3]
C0023890
UMLS CUI [4,1]
C0348080
UMLS CUI [4,2]
C1444641
14. patients with history of retinal damage
Description

Retinal damage

Data type

boolean

Alias
UMLS CUI [1]
C0235272
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Similar models

Eligibility Estrogen Receptor Positive Breast Cancer NCT02414776

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Secondary malignant neoplasm of female breast Estrogen receptor positive | Disease Progression | Stable Disease Radiography | TUMOR MARKER LEVEL ELEVATED | Hormone Therapy | Progression-Free Survival
Item
1. patients ≥ 18 years of age with histologically confirmed, metastatic er + breast cancer with clinical progression of disease (including radiographically stable disease with at least 50% increment of an elevated tumor marker by two measurements at least 2 weeks apart (this particular tumor marker will be used for disease status assessment in the study) on current hormonal therapy with pfs for at least 3 months.
boolean
C0001779 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C0677946 (UMLS CUI [4,1])
C0034571 (UMLS CUI [4,2])
C0749735 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C0242792 (UMLS CUI [7])
Karnofsky Performance Status | Life Expectancy
Item
2. karnofsky performance status (kps) ≥70% and a life expectancy >3 months.
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Target Lesion Visceral Quantity | Evaluation Tumor Response | Secondary malignant neoplasm of bone Imaging study Positive | Bone scan | Magnetic Resonance Imaging | PET/CT scan | CT | Tumour marker increased
Item
3. participants must have at least one target visceral lesion that allows for evaluation of tumor response or in the case of bone-only metastases, patients need to have a positive imaging study such as bone scan, magnetic resonance imaging (mri) or positron emission tomography-computed tomography (pet-ct) or ct, and an elevated tumor marker at least twice as high as upper limit.
boolean
C2986546 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1261322 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C0153690 (UMLS CUI [3,1])
C1881134 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0203668 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C1699633 (UMLS CUI [6])
C0040405 (UMLS CUI [7])
C0876999 (UMLS CUI [8])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
4. absolute neutrophil count > 1500 mm3, platelet count ≥ 80×109 l, hemoglobin ≥ 8.5 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Creatinine clearance measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
5. creatinine clearance ≥ 30 ml/min, total bilirubin ≤ 2 mg/dl, ast/alt ≤ 3 times the upper limit of normal range
boolean
C0373595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Absence Toxicity Remaining CTCAE Grades | Cancer treatment Previous
Item
6. no remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the principal investigator
boolean
C0332197 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0920425 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Major surgery
Item
7. at least two (2) weeks from prior major surgery
boolean
C0679637 (UMLS CUI [1])
Permission Biopsy lesion | Permission Collection of blood specimen for laboratory procedure
Item
8. willingness to provide permission to biopsy one of the lesions if applicable before the study (all the patients are encouraged to have post-therapy biopsy upon progression of disease, but it is optional) as well as blood samples for pertinent laboratory studies
boolean
C0521104 (UMLS CUI [1,1])
C0940828 (UMLS CUI [1,2])
C0521104 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization | Sexual Abstinence | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
9. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable non-hormonal contraceptive method (abstinence, or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial -
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430061 (UMLS CUI [7,2])
Item Group
C0680251 (UMLS CUI)
Combined Modality Therapy | Hormone Therapy | everolimus | Investigational New Drugs
Item
1. on combination hormonal therapy with everolimus or any other investigational agent
boolean
C0009429 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0541315 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Symptomatic Untreated | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic Untreated | Metastatic malignant neoplasm to brain Symptomatic Treated | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic Treated | Steroids Required
Item
2. patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid 18jul2014 protocol v3: abc 01 anti-autophagy for met breast cancer page 4 of 16
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C1704231 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0220650 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1704231 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C0038317 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
Lymphangitis carcinomatosa Involving Lung Percentage | Neoplasm Metastasis Involving Liver Third | Ultrasonography | Computed Tomography
Item
3. lymphangitic carcinomatosis involving ≥ 50% of the lungs; evidence of metastases involving more than one third of the liver on sonogram or computed tomography
boolean
C0238258 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0027627 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C0442047 (UMLS CUI [2,4])
C0041618 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
Breast Feeding
Item
4. lactating females
boolean
C0006147 (UMLS CUI [1])
Heart Disease Uncontrolled | Congestive heart failure | Angina Pectoris | Hypertensive disease
Item
5. uncontrolled cardiac disease, congestive heart failure, angina or hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
Myocardial Infarction | Angina, Unstable
Item
6. myocardial infarction or unstable angina within 2 months of treatment
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
7. known human immunodeficiency virus (hiv) infection or chronic active hepatitis b or c (patients are not required to be tested for the presence of such viruses prior to therapy on this protocol)
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Communicable Disease Serious CTCAE Grades
Item
8. active clinically serious infection > ctcae (version 4.03) grade 2
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Wound, non-healed | Ulcer | Fracture
Item
9. serious non-healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Mental disorders Limiting Safety | Mental disorders Limiting Protocol Compliance | Social situation Limiting Safety | Social situation Limiting Protocol Compliance
Item
10. concurrent psychiatric illness/social situations that would limit safety and compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0748872 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Informed Consent Unable | Protocol Compliance Unable
Item
11. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Investigational New Drugs
Item
12. currently receiving any other investigational therapeutic agents
boolean
C0013230 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase | Porphyria | Liver Cirrhosis | Condition At risk
Item
13. patients with known glucose-6-phosphate dehydrogenase deficiency, porphyria, cirrhosis or any other conditions with potential significant known risks
boolean
C2939465 (UMLS CUI [1])
C3463940 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
Retinal damage
Item
14. patients with history of retinal damage
boolean
C0235272 (UMLS CUI [1])
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