ID

35865

Beskrivning

Identification of the Molecular Alterations Associated With Resistance to Endocrine Therapy and Impacting Treatment With mTOR Inhibitor of HR+ Metastatic Breast Cancer in Post-menopausal Women; ODM derived from: https://clinicaltrials.gov/show/NCT02444390

Länk

https://clinicaltrials.gov/show/NCT02444390

Nyckelord

Versioner (1)
  1. 2019-03-29 2019-03-29 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

29 mars 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Estrogen Hormone Receptor-positive Metastatic Breast Cancer NCT02444390

Engelsk

Eligibility Estrogen Hormone Receptor-positive Metastatic Breast Cancer NCT02444390

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
eligible for everolimus+exemestane treatment as required by the marketing authorisation conditions
Beskrivning

Eligible Everolimus | Eligible Exemestane

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0541315
UMLS CUI [2,1]
C1548635
UMLS CUI [2,2]
C0851344
1. women (or men) with histologically-proven er+ and/or pr+ /her2- metastatic breast adenocarcinoma or locally advanced disease who cannot be treated with surgery and/or radiation therapy
Beskrivning

Gender | Breast adenocarcinoma metastatic Estrogen receptor positive | Breast adenocarcinoma metastatic Progesterone receptor positive HER2 Negative | Advanced disease Locally | Operative Surgical Procedures Unsuccessful | Therapeutic radiology procedure Unsuccessful

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C1697918
UMLS CUI [2,2]
C0279754
UMLS CUI [3,1]
C1697918
UMLS CUI [3,2]
C0279759
UMLS CUI [3,3]
C2348908
UMLS CUI [4,1]
C0679246
UMLS CUI [4,2]
C1517927
UMLS CUI [5,1]
C0543467
UMLS CUI [5,2]
C1272705
UMLS CUI [6,1]
C1522449
UMLS CUI [6,2]
C1272705
2. postmenopausal women
Beskrivning

Postmenopausal state

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
3. asymptomatic if visceral disease
Beskrivning

Disease Visceral Asymptomatic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0442045
UMLS CUI [1,3]
C0231221
4. second line hormonotherapy or more for metastatic or locally advanced disease after recurrence or progression following a non-steroidal aromatase inhibitor (in adjuvant or metastatic setting)
Beskrivning

Second line Hormone Therapy Neoplasm Metastasis | Second line Hormone Therapy Advanced disease Locally | Status post Recurrence | Status post Disease Progression | Non-Steroidal Aromatase Inhibitor | Adjuvant therapy | Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1710038
UMLS CUI [1,2]
C0279025
UMLS CUI [1,3]
C0027627
UMLS CUI [2,1]
C1710038
UMLS CUI [2,2]
C0279025
UMLS CUI [2,3]
C0679246
UMLS CUI [2,4]
C1517927
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0034897
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0242656
UMLS CUI [5]
C1518386
UMLS CUI [6]
C0677850
UMLS CUI [7]
C0027627
eligible for the biopsy
Beskrivning

Eligible Biopsy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1548635
UMLS CUI [1,2]
C0005558
5. progressive disease under endocrine therapy at the time of inclusion
Beskrivning

Hormone Therapy Progressive Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1335499
6. treatment with everolimus and exemestane not yet started
Beskrivning

Treatment Start Absent Everolimus | Treatment Start Absent Exemestane

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0541315
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0439659
UMLS CUI [2,3]
C0332197
UMLS CUI [2,4]
C0851344
7. patients with metastases that can be biopsied, except bone metastases
Beskrivning

Neoplasm Metastasis Biopsy | Exception Secondary malignant neoplasm of bone

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027627
UMLS CUI [1,2]
C0005558
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0153690
8. measurable or evaluable disease
Beskrivning

Measurable Disease | Evaluable Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1516986
9. age ≥ 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
10. who performance status 0/1
Beskrivning

WHO performance status scale

Datatyp

boolean

Alias
UMLS CUI [1]
C1298650
11. provision of signed and dated, written informed consent prior to any protocol specific procedure, including biopsy
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
12. patient with social insurance coverage
Beskrivning

Social insurance Coverage

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0037435
UMLS CUI [1,2]
C0376629
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. contraindications for everolimus+exemestane treatment 2. previous treatment with an anti-mtor therapy 3. more than 1 previous line of chemotherapy in metastatic setting 4. life expectancy <3 months, 5. spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
Beskrivning

Medical contraindication Everolimus | Medical contraindication Exemestane | mTOR Inhibitors | Chemotherapy Regime Quantity Neoplasm Metastasis | Life Expectancy | Compression of spinal cord | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Progressive | Exception Metastatic malignant neoplasm to brain Asymptomatic | Exception Metastatic malignant neoplasm to brain Treated | Exception Steroids Absent Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0541315
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0851344
UMLS CUI [3]
C1515672
UMLS CUI [4,1]
C0392920
UMLS CUI [4,2]
C1265611
UMLS CUI [4,3]
C0027627
UMLS CUI [5]
C0023671
UMLS CUI [6]
C0037926
UMLS CUI [7,1]
C0220650
UMLS CUI [7,2]
C0231220
UMLS CUI [8,1]
C0220650
UMLS CUI [8,2]
C0205329
UMLS CUI [9,1]
C1705847
UMLS CUI [9,2]
C0220650
UMLS CUI [9,3]
C0231221
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0220650
UMLS CUI [10,3]
C1522326
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0038317
UMLS CUI [11,3]
C0332197
UMLS CUI [11,4]
C0205360
6. haematopoietic function or organ impairment as shown by the following criteria:
Beskrivning

Function Hematopoietic Impairment | Organ Impairment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031843
UMLS CUI [1,2]
C0229601
UMLS CUI [1,3]
C0221099
UMLS CUI [2,1]
C0178784
UMLS CUI [2,2]
C0221099
polynuclear neutrophils < 1.5 x 109/l
Beskrivning

Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
platelets < 100 x 109/l
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
haemoglobin < 90 g/l
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
alat/asat > 2.5x uln in the absence of or > 5x uln in the presence of liver metastases
Beskrivning

Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of liver Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0151905
UMLS CUI [2]
C0151904
UMLS CUI [3]
C0494165
UMLS CUI [4,1]
C0494165
UMLS CUI [4,2]
C0332197
bilirubin > 1.5xuln
Beskrivning

Elevated total bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C0741494
creatinine clearance ≤50 ml/min (measured or calculated by cockroft and gault formula)
Beskrivning

Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1]
C0373595
UMLS CUI [2]
C2711451
calcium and phosphate > uln 7. abnormal coagulation or any other medical situation contraindicating biopsy 8. bone metastases when this is the only site of biopsiable disease 9. any condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
Beskrivning

Serum calcium increased | Phosphate increased | Abnormality of coagulation | Other medical condition Biopsy Contraindicated | Secondary malignant neoplasm of bone | Condition Study Subject Participation Status Unfavorable | Condition compromises Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1]
C0595928
UMLS CUI [2]
C0860988
UMLS CUI [3]
C1846821
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0005558
UMLS CUI [4,3]
C1444657
UMLS CUI [5]
C0153690
UMLS CUI [6,1]
C0348080
UMLS CUI [6,2]
C2348568
UMLS CUI [6,3]
C3640815
UMLS CUI [7,1]
C0348080
UMLS CUI [7,2]
C2945640
UMLS CUI [7,3]
C0525058
10. individuals deprived of liberty or placed under the authority of a tutor.
Beskrivning

Freedom Deprivation | Guardianship

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0016694
UMLS CUI [1,2]
C0871712
UMLS CUI [2]
C0870627
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Similar models

Eligibility Estrogen Hormone Receptor-positive Metastatic Breast Cancer NCT02444390

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Eligible Everolimus | Eligible Exemestane
Item
eligible for everolimus+exemestane treatment as required by the marketing authorisation conditions
boolean
C1548635 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
C1548635 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
Gender | Breast adenocarcinoma metastatic Estrogen receptor positive | Breast adenocarcinoma metastatic Progesterone receptor positive HER2 Negative | Advanced disease Locally | Operative Surgical Procedures Unsuccessful | Therapeutic radiology procedure Unsuccessful
Item
1. women (or men) with histologically-proven er+ and/or pr+ /her2- metastatic breast adenocarcinoma or locally advanced disease who cannot be treated with surgery and/or radiation therapy
boolean
C0079399 (UMLS CUI [1])
C1697918 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C1697918 (UMLS CUI [3,1])
C0279759 (UMLS CUI [3,2])
C2348908 (UMLS CUI [3,3])
C0679246 (UMLS CUI [4,1])
C1517927 (UMLS CUI [4,2])
C0543467 (UMLS CUI [5,1])
C1272705 (UMLS CUI [5,2])
C1522449 (UMLS CUI [6,1])
C1272705 (UMLS CUI [6,2])
Postmenopausal state
Item
2. postmenopausal women
boolean
C0232970 (UMLS CUI [1])
Disease Visceral Asymptomatic
Item
3. asymptomatic if visceral disease
boolean
C0012634 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C0231221 (UMLS CUI [1,3])
Second line Hormone Therapy Neoplasm Metastasis | Second line Hormone Therapy Advanced disease Locally | Status post Recurrence | Status post Disease Progression | Non-Steroidal Aromatase Inhibitor | Adjuvant therapy | Neoplasm Metastasis
Item
4. second line hormonotherapy or more for metastatic or locally advanced disease after recurrence or progression following a non-steroidal aromatase inhibitor (in adjuvant or metastatic setting)
boolean
C1710038 (UMLS CUI [1,1])
C0279025 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C1710038 (UMLS CUI [2,1])
C0279025 (UMLS CUI [2,2])
C0679246 (UMLS CUI [2,3])
C1517927 (UMLS CUI [2,4])
C0231290 (UMLS CUI [3,1])
C0034897 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0242656 (UMLS CUI [4,2])
C1518386 (UMLS CUI [5])
C0677850 (UMLS CUI [6])
C0027627 (UMLS CUI [7])
Eligible Biopsy
Item
eligible for the biopsy
boolean
C1548635 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
Hormone Therapy Progressive Disease
Item
5. progressive disease under endocrine therapy at the time of inclusion
boolean
C0279025 (UMLS CUI [1,1])
C1335499 (UMLS CUI [1,2])
Treatment Start Absent Everolimus | Treatment Start Absent Exemestane
Item
6. treatment with everolimus and exemestane not yet started
boolean
C0087111 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0541315 (UMLS CUI [1,4])
C0087111 (UMLS CUI [2,1])
C0439659 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C0851344 (UMLS CUI [2,4])
Neoplasm Metastasis Biopsy | Exception Secondary malignant neoplasm of bone
Item
7. patients with metastases that can be biopsied, except bone metastases
boolean
C0027627 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
Measurable Disease | Evaluable Disease
Item
8. measurable or evaluable disease
boolean
C1513041 (UMLS CUI [1])
C1516986 (UMLS CUI [2])
Age
Item
9. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
WHO performance status scale
Item
10. who performance status 0/1
boolean
C1298650 (UMLS CUI [1])
Informed Consent
Item
11. provision of signed and dated, written informed consent prior to any protocol specific procedure, including biopsy
boolean
C0021430 (UMLS CUI [1])
Social insurance Coverage
Item
12. patient with social insurance coverage
boolean
C0037435 (UMLS CUI [1,1])
C0376629 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Medical contraindication Everolimus | Medical contraindication Exemestane | mTOR Inhibitors | Chemotherapy Regime Quantity Neoplasm Metastasis | Life Expectancy | Compression of spinal cord | Metastatic malignant neoplasm to brain Symptomatic | Metastatic malignant neoplasm to brain Progressive | Exception Metastatic malignant neoplasm to brain Asymptomatic | Exception Metastatic malignant neoplasm to brain Treated | Exception Steroids Absent Stable
Item
1. contraindications for everolimus+exemestane treatment 2. previous treatment with an anti-mtor therapy 3. more than 1 previous line of chemotherapy in metastatic setting 4. life expectancy <3 months, 5. spinal cord compression and/or symptomatic or progressive brain metastases (unless asymptomatic or treated and stable off steroids for at least 30 days prior to start of study drug).
boolean
C1301624 (UMLS CUI [1,1])
C0541315 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
C1515672 (UMLS CUI [3])
C0392920 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0027627 (UMLS CUI [4,3])
C0023671 (UMLS CUI [5])
C0037926 (UMLS CUI [6])
C0220650 (UMLS CUI [7,1])
C0231220 (UMLS CUI [7,2])
C0220650 (UMLS CUI [8,1])
C0205329 (UMLS CUI [8,2])
C1705847 (UMLS CUI [9,1])
C0220650 (UMLS CUI [9,2])
C0231221 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0220650 (UMLS CUI [10,2])
C1522326 (UMLS CUI [10,3])
C1705847 (UMLS CUI [11,1])
C0038317 (UMLS CUI [11,2])
C0332197 (UMLS CUI [11,3])
C0205360 (UMLS CUI [11,4])
Function Hematopoietic Impairment | Organ Impairment
Item
6. haematopoietic function or organ impairment as shown by the following criteria:
boolean
C0031843 (UMLS CUI [1,1])
C0229601 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0178784 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Neutrophil count
Item
polynuclear neutrophils < 1.5 x 109/l
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelets < 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
haemoglobin < 90 g/l
boolean
C0518015 (UMLS CUI [1])
Alanine aminotransferase increased | Aspartate aminotransferase increased | Secondary malignant neoplasm of liver | Secondary malignant neoplasm of liver Absent
Item
alat/asat > 2.5x uln in the absence of or > 5x uln in the presence of liver metastases
boolean
C0151905 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
C0494165 (UMLS CUI [3])
C0494165 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Elevated total bilirubin
Item
bilirubin > 1.5xuln
boolean
C0741494 (UMLS CUI [1])
Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
creatinine clearance ≤50 ml/min (measured or calculated by cockroft and gault formula)
boolean
C0373595 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Serum calcium increased | Phosphate increased | Abnormality of coagulation | Other medical condition Biopsy Contraindicated | Secondary malignant neoplasm of bone | Condition Study Subject Participation Status Unfavorable | Condition compromises Protocol Compliance
Item
calcium and phosphate > uln 7. abnormal coagulation or any other medical situation contraindicating biopsy 8. bone metastases when this is the only site of biopsiable disease 9. any condition which in the investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
boolean
C0595928 (UMLS CUI [1])
C0860988 (UMLS CUI [2])
C1846821 (UMLS CUI [3])
C3843040 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
C1444657 (UMLS CUI [4,3])
C0153690 (UMLS CUI [5])
C0348080 (UMLS CUI [6,1])
C2348568 (UMLS CUI [6,2])
C3640815 (UMLS CUI [6,3])
C0348080 (UMLS CUI [7,1])
C2945640 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Freedom Deprivation | Guardianship
Item
10. individuals deprived of liberty or placed under the authority of a tutor.
boolean
C0016694 (UMLS CUI [1,1])
C0871712 (UMLS CUI [1,2])
C0870627 (UMLS CUI [2])
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