ID

14812

Beskrivning

Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Carboplatin in Triple Negative Breast Cancer (TNBC); ODM derived from: https://clinicaltrials.gov/show/NCT02341911

Länk

https://clinicaltrials.gov/show/NCT02341911

Nyckelord

Versioner (1)
  1. 2016-04-29 2016-04-29 -
Uppladdad den

29 april 2016

DOI

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Creative Commons BY 4.0
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Eligibility Breast Cancer NCT02341911

Engelsk

Eligibility Breast Cancer NCT02341911

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. histological proven unresectable recurrent or advanced breast cancer, including de novo stage iv disease.
Beskrivning

Breast Carcinoma unresectable | Carcinoma breast stage IV de novo

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C1519810
UMLS CUI [2,1]
C0278488
UMLS CUI [2,2]
C1515568
2. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er <1%, pr <1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator.
Beskrivning

Triple-Negative Breast Cancer Finding | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Immunohistochemistry | Human epidermal growth factor 2 negative carcinoma of breast | Human epidermal growth factor 2 gene amplification negative | Fluorescent in Situ Hybridization

Datatyp

boolean

Alias
UMLS CUI [1]
C2348819
UMLS CUI [2]
C2919271
UMLS CUI [3]
C2919590
UMLS CUI [4]
C0069515
UMLS CUI [5]
C0021044
UMLS CUI [6]
C2316304
UMLS CUI [7]
C3874302
UMLS CUI [8]
C0162789
3. no prior chemotherapy for metastatic breast cancer is permitted. prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
Beskrivning

Prior Chemotherapy Carcinoma breast stage IV | Adjuvant therapy | Neoadjuvant Therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0278488
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0600558
4. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1)
Beskrivning

Measurable Disease Response Evaluation Criteria in Solid Tumors

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1513041
UMLS CUI [1,2]
C1709926
5. performance status no more than 1
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
6. all patients enrolled are required to have adequate hematologic, hepatic, and renal function
Beskrivning

Hematologic function | Liver function | Renal function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
7. life expectancy longer than 12 weeks
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
8. no serious medical history of heart, lung, liver and kidney
Beskrivning

Heart Diseases | Lung diseases | Liver diseases | Kidney Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0018799
UMLS CUI [2]
C0024115
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0022658
9. be able to understand the study procedures and sign informed consent.
Beskrivning

Comprehension Study Protocol Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0021430
10. patients with good compliance
Beskrivning

Compliance behavior Good

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0205170
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative Ultrasonics (sound)

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [3,3]
C1456803
2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
Beskrivning

Childbearing Potential | Unwilling Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118
UMLS CUI [2,1]
C0558080
UMLS CUI [2,2]
C0700589
3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
Beskrivning

Therapeutic radiology procedure Entire axial skeleton | Toxic effect Prior radiation therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1522449
UMLS CUI [1,2]
C1321508
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0279134
4. treatment with an investigational product within 4 weeks before the first treatment
Beskrivning

Therapeutic procedure Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0013230
5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration
Beskrivning

CNS metastases | Metastatic malignant neoplasm to brain | Cranial Irradiation | Measurable Disease | Therapeutic radiology procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0686377
UMLS CUI [2]
C0220650
UMLS CUI [3]
C0079172
UMLS CUI [4]
C1513041
UMLS CUI [5]
C1522449
6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
Beskrivning

Malignant Neoplasms | Hematologic Neoplasms | Skin carcinoma | Cervical Intraepithelial Neoplasia

Datatyp

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0376545
UMLS CUI [3]
C0699893
UMLS CUI [4]
C0206708
7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
Beskrivning

Cardiovascular Diseases | Liver diseases | Respiration Disorders | Kidney Diseases | Abnormality of blood and blood-forming tissues | Abnormality of the endocrine system | nervous system disorder | Mental disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0007222
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0035204
UMLS CUI [4]
C0022658
UMLS CUI [5]
C0850715
UMLS CUI [6]
C4025823
UMLS CUI [7]
C0027765
UMLS CUI [8]
C0004936
8. uncontrolled serious infection
Beskrivning

Communicable Diseases Uncontrolled

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
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Similar models

Eligibility Breast Cancer NCT02341911

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma unresectable | Carcinoma breast stage IV de novo
Item
1. histological proven unresectable recurrent or advanced breast cancer, including de novo stage iv disease.
boolean
C0678222 (UMLS CUI [1,1])
C1519810 (UMLS CUI [1,2])
C0278488 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
Triple-Negative Breast Cancer Finding | Status of estrogen receptors of neoplasm | Status of progesterone receptors of neoplasm | erbB-2 Receptor | Immunohistochemistry | Human epidermal growth factor 2 negative carcinoma of breast | Human epidermal growth factor 2 gene amplification negative | Fluorescent in Situ Hybridization
Item
2. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er <1%, pr <1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator.
boolean
C2348819 (UMLS CUI [1])
C2919271 (UMLS CUI [2])
C2919590 (UMLS CUI [3])
C0069515 (UMLS CUI [4])
C0021044 (UMLS CUI [5])
C2316304 (UMLS CUI [6])
C3874302 (UMLS CUI [7])
C0162789 (UMLS CUI [8])
Prior Chemotherapy Carcinoma breast stage IV | Adjuvant therapy | Neoadjuvant Therapy
Item
3. no prior chemotherapy for metastatic breast cancer is permitted. prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment.
boolean
C1514457 (UMLS CUI [1,1])
C0278488 (UMLS CUI [1,2])
C0677850 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
Measurable Disease Response Evaluation Criteria in Solid Tumors
Item
4. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1)
boolean
C1513041 (UMLS CUI [1,1])
C1709926 (UMLS CUI [1,2])
ECOG performance status
Item
5. performance status no more than 1
boolean
C1520224 (UMLS CUI [1])
Hematologic function | Liver function | Renal function
Item
6. all patients enrolled are required to have adequate hematologic, hepatic, and renal function
boolean
C0221130 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Life Expectancy
Item
7. life expectancy longer than 12 weeks
boolean
C0023671 (UMLS CUI [1])
Heart Diseases | Lung diseases | Liver diseases | Kidney Diseases
Item
8. no serious medical history of heart, lung, liver and kidney
boolean
C0018799 (UMLS CUI [1])
C0024115 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
Comprehension Study Protocol Informed Consent
Item
9. be able to understand the study procedures and sign informed consent.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Compliance behavior Good
Item
10. patients with good compliance
boolean
C1321605 (UMLS CUI [1,1])
C0205170 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative Ultrasonics (sound)
Item
1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound)
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C1456803 (UMLS CUI [3,3])
Childbearing Potential | Unwilling Contraceptive methods
Item
2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study
boolean
C3831118 (UMLS CUI [1])
C0558080 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Therapeutic radiology procedure Entire axial skeleton | Toxic effect Prior radiation therapy
Item
3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy
boolean
C1522449 (UMLS CUI [1,1])
C1321508 (UMLS CUI [1,2])
C0600688 (UMLS CUI [2,1])
C0279134 (UMLS CUI [2,2])
Therapeutic procedure Investigational New Drugs
Item
4. treatment with an investigational product within 4 weeks before the first treatment
boolean
C0087111 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
CNS metastases | Metastatic malignant neoplasm to brain | Cranial Irradiation | Measurable Disease | Therapeutic radiology procedure
Item
5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C0079172 (UMLS CUI [3])
C1513041 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
Malignant Neoplasms | Hematologic Neoplasms | Skin carcinoma | Cervical Intraepithelial Neoplasia
Item
6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.
boolean
C0006826 (UMLS CUI [1])
C0376545 (UMLS CUI [2])
C0699893 (UMLS CUI [3])
C0206708 (UMLS CUI [4])
Cardiovascular Diseases | Liver diseases | Respiration Disorders | Kidney Diseases | Abnormality of blood and blood-forming tissues | Abnormality of the endocrine system | nervous system disorder | Mental disorders
Item
7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions
boolean
C0007222 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0035204 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0850715 (UMLS CUI [5])
C4025823 (UMLS CUI [6])
C0027765 (UMLS CUI [7])
C0004936 (UMLS CUI [8])
Communicable Diseases Uncontrolled
Item
8. uncontrolled serious infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
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