ID

36381

Beskrivning

Eribulin Plus Gemcitabine (EG) vs Paclitaxel Plus Gemcitabine (PG) in HER2-Negative Metastatic Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02263495

Länk

https://clinicaltrials.gov/show/NCT02263495

Nyckelord

Versioner (1)
  1. 2019-05-08 2019-05-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 maj 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Metastatic Breast Cancer NCT02263495

Engelsk

Eligibility Metastatic Breast Cancer NCT02263495

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histologically confirmed metastatic, or recurrent breast cancer
Beskrivning

Secondary malignant neoplasm of female breast | Breast cancer recurrent

Datatyp

boolean

Alias
UMLS CUI [1]
C0346993
UMLS CUI [2]
C0278493
2. her2-negative breast cancer
Beskrivning

Breast Carcinoma HER2 Negative

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C2348908
3. age > 18 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
4. ecog performance status 0 - 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
5. pre- or postmenopausal breast cancer patients with measurable or non-measurable lesions, who are candidates for chemotherapy
Beskrivning

Premenopausal breast cancer | Breast Carcinoma Postmenopausal | Measurable Disease | Non-Measurable Lesion | Patients Appropriate Chemotherapy

Datatyp

boolean

Alias
UMLS CUI [1]
C0741682
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0232970
UMLS CUI [3]
C1513041
UMLS CUI [4]
C1334988
UMLS CUI [5,1]
C0030705
UMLS CUI [5,2]
C1548787
UMLS CUI [5,3]
C0392920
6. life expectancy ≥ 3 months
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
7. no prior history of chemotherapy for metastatic, recurrent breast cancer
Beskrivning

Prior Chemotherapy Absent Secondary malignant neoplasm of female breast | Prior Chemotherapy Absent Breast cancer recurrent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C0346993
UMLS CUI [2,1]
C1514457
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0278493
8. patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it has been 12 months since completion of regimen.
Beskrivning

Taxane Neoadjuvant Therapy Completed | Taxane Adjuvant therapy Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0215136
UMLS CUI [1,2]
C0600558
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0215136
UMLS CUI [2,2]
C0677850
UMLS CUI [2,3]
C0205197
9. patients either may or may not have a prior anthracycline containing regimen.
Beskrivning

Prior Therapy Anthracyclines | Absence Prior Therapy Anthracyclines

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0282564
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C1514463
UMLS CUI [2,3]
C0282564
10. prior hormonal therapy as a treatment of metastatic disease is allowed. but antitumoral hormonal therapy must be terminated prior to enrollment(up to the date of randomization)
Beskrivning

Prior Hormone Therapy Neoplasm Metastasis | Hormone Therapy Completed Against Tumor

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C0027627
UMLS CUI [2,1]
C0279025
UMLS CUI [2,2]
C0205197
UMLS CUI [2,3]
C0521124
UMLS CUI [2,4]
C0027651
11. prior radiation therapy allowed as long as < 25% of the bone marrow has been treated, and the patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed 2 weeks before study entry.
Beskrivning

Prior radiation therapy Bone Marrow Percentage | Toxic effects Due to Therapeutic procedure | Patient recovered | Absence Prior radiation therapy Whole Pelvis | Prior radiation therapy Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0279134
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C0439165
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0087111
UMLS CUI [3]
C1115804
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0279134
UMLS CUI [4,3]
C3827467
UMLS CUI [5,1]
C0279134
UMLS CUI [5,2]
C0205197
12. bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of randomized therapy. it must be initiated prior to day of treatment (cycle 1, day 1). patients may continue on bisphosphonates who already established on bisphosphonate therapy for bone metastases
Beskrivning

Diphosphonates | Therapy Secondary malignant neoplasm of bone

Datatyp

boolean

Alias
UMLS CUI [1]
C0012544
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0153690
13. adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul, ≥ hemoglobin 9.0 g/dl)
Beskrivning

Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0032181
UMLS CUI [4]
C0518015
14. adequate renal function (≤ serum creatinine 1.5 mg/dl or ccr ≥ 50 ml/min)
Beskrivning

Renal function | Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0373595
15. adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ ast & altx3 upper normal limit or ast and alt ≤ 5.0xuln if judged by the investigator to be related to liver metastases)
Beskrivning

Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C1278039
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5,1]
C0439849
UMLS CUI [5,2]
C0494165
16. written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. serious uncontrolled intercurrent infections
Beskrivning

Communicable Diseases Serious Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
UMLS CUI [1,3]
C0205318
2. serious intercurrent medical or psychiatric illness, including active cardiac disease
Beskrivning

Comorbidity Serious | Mental disorders Serious | Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C0018799
3. pregnancy or breast feeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
4. second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
Beskrivning

Second Primary Cancer | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma Treated | Exception Cancer Other Treated | Exception Recurrence Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0751623
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1707251
UMLS CUI [4,3]
C1522326
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0034897
UMLS CUI [5,3]
C0332197
5. documented parenchymal or leptomeningeal brain metastasis
Beskrivning

Metastatic malignant neoplasm to brain Parenchymal | Metastatic malignant neoplasm to brain Leptomeningeal

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0220650
UMLS CUI [1,2]
C4277702
UMLS CUI [2,1]
C0220650
UMLS CUI [2,2]
C0521401
6. peripheral neuropathy ≥ grade 2
Beskrivning

Peripheral Neuropathy CTCAE Grades

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C1516728
7. prior treatment with gemcitabine will not be allowed.
Beskrivning

gemcitabine

Datatyp

boolean

Alias
UMLS CUI [1]
C0045093
8. her-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed
Beskrivning

Breast Carcinoma HER2 Protein Overexpression Plus Trastuzumab

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1515560
UMLS CUI [1,3]
C0332287
UMLS CUI [1,4]
C0728747
9. women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial
Beskrivning

Childbearing Potential Contraceptive methods Unwilling

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [1,3]
C0558080
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Similar models

Eligibility Metastatic Breast Cancer NCT02263495

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Secondary malignant neoplasm of female breast | Breast cancer recurrent
Item
1. histologically confirmed metastatic, or recurrent breast cancer
boolean
C0346993 (UMLS CUI [1])
C0278493 (UMLS CUI [2])
Breast Carcinoma HER2 Negative
Item
2. her2-negative breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
Age
Item
3. age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Premenopausal breast cancer | Breast Carcinoma Postmenopausal | Measurable Disease | Non-Measurable Lesion | Patients Appropriate Chemotherapy
Item
5. pre- or postmenopausal breast cancer patients with measurable or non-measurable lesions, who are candidates for chemotherapy
boolean
C0741682 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3])
C1334988 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
Life Expectancy
Item
6. life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Prior Chemotherapy Absent Secondary malignant neoplasm of female breast | Prior Chemotherapy Absent Breast cancer recurrent
Item
7. no prior history of chemotherapy for metastatic, recurrent breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278493 (UMLS CUI [2,3])
Taxane Neoadjuvant Therapy Completed | Taxane Adjuvant therapy Completed
Item
8. patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it has been 12 months since completion of regimen.
boolean
C0215136 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0215136 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Prior Therapy Anthracyclines | Absence Prior Therapy Anthracyclines
Item
9. patients either may or may not have a prior anthracycline containing regimen.
boolean
C1514463 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0282564 (UMLS CUI [2,3])
Prior Hormone Therapy Neoplasm Metastasis | Hormone Therapy Completed Against Tumor
Item
10. prior hormonal therapy as a treatment of metastatic disease is allowed. but antitumoral hormonal therapy must be terminated prior to enrollment(up to the date of randomization)
boolean
C1514460 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0027651 (UMLS CUI [2,4])
Prior radiation therapy Bone Marrow Percentage | Toxic effects Due to Therapeutic procedure | Patient recovered | Absence Prior radiation therapy Whole Pelvis | Prior radiation therapy Completed
Item
11. prior radiation therapy allowed as long as < 25% of the bone marrow has been treated, and the patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed 2 weeks before study entry.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C0279134 (UMLS CUI [4,2])
C3827467 (UMLS CUI [4,3])
C0279134 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
Diphosphonates | Therapy Secondary malignant neoplasm of bone
Item
12. bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of randomized therapy. it must be initiated prior to day of treatment (cycle 1, day 1). patients may continue on bisphosphonates who already established on bisphosphonate therapy for bone metastases
boolean
C0012544 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
13. adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul, ≥ hemoglobin 9.0 g/dl)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
14. adequate renal function (≤ serum creatinine 1.5 mg/dl or ccr ≥ 50 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
15. adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ ast & altx3 upper normal limit or ast and alt ≤ 5.0xuln if judged by the investigator to be related to liver metastases)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
Informed Consent
Item
16. written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Communicable Diseases Serious Uncontrolled
Item
1. serious uncontrolled intercurrent infections
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Comorbidity Serious | Mental disorders Serious | Heart Disease
Item
2. serious intercurrent medical or psychiatric illness, including active cardiac disease
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
3. pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Second Primary Cancer | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma Treated | Exception Cancer Other Treated | Exception Recurrence Absent
Item
4. second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0034897 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Metastatic malignant neoplasm to brain Parenchymal | Metastatic malignant neoplasm to brain Leptomeningeal
Item
5. documented parenchymal or leptomeningeal brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0521401 (UMLS CUI [2,2])
Peripheral Neuropathy CTCAE Grades
Item
6. peripheral neuropathy ≥ grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
gemcitabine
Item
7. prior treatment with gemcitabine will not be allowed.
boolean
C0045093 (UMLS CUI [1])
Breast Carcinoma HER2 Protein Overexpression Plus Trastuzumab
Item
8. her-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed
boolean
C0678222 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C0728747 (UMLS CUI [1,4])
Childbearing Potential Contraceptive methods Unwilling
Item
9. women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
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