ID

39896

Descripción

Myocet + Cyclophosphamide + Metformin Vs Myocet + Cyclophosphamide in 1st Line Treatment of HER2 Neg. Metastatic Breast Cancer Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01885013

Link

https://clinicaltrials.gov/show/NCT01885013

Palabras clave

Versiones (1)
  1. 2/3/20 2/3/20 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de marzo de 2020

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Human Epidermal Growth Factor 2 Negative Carcinoma of Breast NCT01885013

Inglés

Eligibility Human Epidermal Growth Factor 2 Negative Carcinoma of Breast NCT01885013

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed breast cancer
Descripción

Breast Carcinoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678222
2. metastatic disease
Descripción

Neoplasm Metastasis

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0027627
3. her2 negative disease, as measured by ihc or fish
Descripción

Disease HER2 Negative Immunohistochemistry | Disease HER2 Negative FISH

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348908
UMLS CUI [1,3]
C0021044
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C2348908
UMLS CUI [2,3]
C0162789
4. non endocrine responsive disease (negative hormonal status or failure of endocrine therapy for mbc)
Descripción

Disease Unresponsive to Hormone Therapy | Status Hormonal Negative | Hormone Therapy failed Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0205269
UMLS CUI [1,3]
C0279025
UMLS CUI [2,1]
C0449438
UMLS CUI [2,2]
C0458083
UMLS CUI [2,3]
C1513916
UMLS CUI [3,1]
C0279025
UMLS CUI [3,2]
C0231175
UMLS CUI [3,3]
C0346993
5. patients with measurable and/or non-measurable disease according to recist criteria (version 1.1)
Descripción

Measurable Disease | Non-Measurable Lesion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
UMLS CUI [2]
C1334988
6. homa index calculated according to matthews' formula
Descripción

Homeostasis model assessment | Other Coding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1829779
UMLS CUI [2]
C3846158
7. prior endocrine therapy is allowed, in the adjuvant and/or metastatic setting
Descripción

Prior Hormone Therapy Adjuvant Setting | Prior Hormone Therapy Metastatic Setting

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514460
UMLS CUI [1,2]
C1514460
UMLS CUI [1,3]
C4085632
8. prior chemotherapy is allowed, only in adjuvant setting, provided it is terminated at least 12 months before study entry. adjuvant anthracyclines are allowed if prior cumulative dose does not exceed 360 mg/m2 in case of epirubicin and 280 mg/m2 in case of doxorubicin. adjuvant taxanes are allowed.
Descripción

Prior Chemotherapy Adjuvant Setting Completed | Anthracyclines Adjuvant | Epirubicin Cumulative Dose | Doxorubicin Cumulative Dose | Taxanes Adjuvant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C4084850
UMLS CUI [1,3]
C0205197
UMLS CUI [2,1]
C0282564
UMLS CUI [2,2]
C1522673
UMLS CUI [3,1]
C0014582
UMLS CUI [3,2]
C2986497
UMLS CUI [4,1]
C0013089
UMLS CUI [4,2]
C2986497
UMLS CUI [5,1]
C0796419
UMLS CUI [5,2]
C1522673
9. age 18-75 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
10. life expectancy of greater than 3 months
Descripción

Life Expectancy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023671
11. ecog performance status <2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
12. patients must have normal organ and marrow function:
Descripción

Organ function | Bone Marrow function

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
leukocytes >=3,000/μl
Descripción

White Blood Cell Count procedure

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count >=1,500/μl
Descripción

Absolute neutrophil count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0948762
platelets >=100,000/μl
Descripción

Platelet Count measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032181
total bilirubin within normal institutional limits
Descripción

Bilirubin total normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0860928
ast(sgot)/alt(sgpt) <=1.5 x institutional upper limit of normal
Descripción

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
creatinine within normal institutional limits
Descripción

Creatinine normal

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0860945
13. adequate cardiac function, i.e. left ventricular ejection fraction (lvef)>= 50%
Descripción

Cardiac function | Left ventricular ejection fraction

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0232164
UMLS CUI [2]
C0428772
14. the effects of liposomal doxorubicin on the developing human fetus at the recommended therapeutic dose are unknown. for this reason and because anthracyclines as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. all women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Descripción

Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C2985296
UMLS CUI [4]
C0004764
UMLS CUI [5]
C0036899
UMLS CUI [6,1]
C3831118
UMLS CUI [6,2]
C0430061
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0430057
15. ability to understand and the willingness to sign a written informed consent document
Descripción

Informed Consent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known diabetes (type 1 or 2)
Descripción

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
2. currently on metformin, sulfonylureas, thiazolidenediones or insulin for any reason (these drugs alter insulin levels)
Descripción

Metformin | Sulfonylureas | Thiazolidinediones | Insulin

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0025598
UMLS CUI [2]
C0038766
UMLS CUI [3]
C1257987
UMLS CUI [4]
C0021641
3. current or previous congestive heart failure, renal failure or liver failure; history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day
Descripción

Congestive heart failure | Kidney Failure | Liver Failure | Acidosis Type Any | Alcohol consumption Alcoholic Beverages U/day

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018802
UMLS CUI [2]
C0035078
UMLS CUI [3]
C0085605
UMLS CUI [4,1]
C0001122
UMLS CUI [4,2]
C0332307
UMLS CUI [4,3]
C1552551
UMLS CUI [5,1]
C0001948
UMLS CUI [5,2]
C0001967
UMLS CUI [5,3]
C0456683
4. creatinine above upper limit of normal for institution, ast above 1.5 times upper limit or normal for institution (to reduce risk of lactic acidosis)
Descripción

Serum creatinine raised | Aspartate aminotransferase increased

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0700225
UMLS CUI [2]
C0151904
5. hypersensitivity or allergy to metformin
Descripción

Metformin allergy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0571648
6. participation in another clinical trial with any investigational agents within 30 days prior to study screening
Descripción

Study Subject Participation Status | Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
7. patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
8. history of allergic reactions attributed to compounds of similar chemical or biologic composition to myocet or other agents used in the study
Descripción

Allergic Reaction Compound Myocet Similar | Allergic Reaction Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C1706082
UMLS CUI [1,3]
C1512062
UMLS CUI [1,4]
C2348205
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
9. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Descripción

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
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Similar models

Eligibility Human Epidermal Growth Factor 2 Negative Carcinoma of Breast NCT01885013

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma
Item
1. patients must have histologically or cytologically confirmed breast cancer
boolean
C0678222 (UMLS CUI [1])
Neoplasm Metastasis
Item
2. metastatic disease
boolean
C0027627 (UMLS CUI [1])
Disease HER2 Negative Immunohistochemistry | Disease HER2 Negative FISH
Item
3. her2 negative disease, as measured by ihc or fish
boolean
C0012634 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
C0021044 (UMLS CUI [1,3])
C0012634 (UMLS CUI [2,1])
C2348908 (UMLS CUI [2,2])
C0162789 (UMLS CUI [2,3])
Disease Unresponsive to Hormone Therapy | Status Hormonal Negative | Hormone Therapy failed Secondary malignant neoplasm of female breast
Item
4. non endocrine responsive disease (negative hormonal status or failure of endocrine therapy for mbc)
boolean
C0012634 (UMLS CUI [1,1])
C0205269 (UMLS CUI [1,2])
C0279025 (UMLS CUI [1,3])
C0449438 (UMLS CUI [2,1])
C0458083 (UMLS CUI [2,2])
C1513916 (UMLS CUI [2,3])
C0279025 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0346993 (UMLS CUI [3,3])
Measurable Disease | Non-Measurable Lesion
Item
5. patients with measurable and/or non-measurable disease according to recist criteria (version 1.1)
boolean
C1513041 (UMLS CUI [1])
C1334988 (UMLS CUI [2])
Homeostasis model assessment | Other Coding
Item
6. homa index calculated according to matthews' formula
boolean
C1829779 (UMLS CUI [1])
C3846158 (UMLS CUI [2])
Prior Hormone Therapy Adjuvant Setting | Prior Hormone Therapy Metastatic Setting
Item
7. prior endocrine therapy is allowed, in the adjuvant and/or metastatic setting
boolean
C1514460 (UMLS CUI [1,1])
C1514460 (UMLS CUI [1,2])
C4085632 (UMLS CUI [1,3])
Prior Chemotherapy Adjuvant Setting Completed | Anthracyclines Adjuvant | Epirubicin Cumulative Dose | Doxorubicin Cumulative Dose | Taxanes Adjuvant
Item
8. prior chemotherapy is allowed, only in adjuvant setting, provided it is terminated at least 12 months before study entry. adjuvant anthracyclines are allowed if prior cumulative dose does not exceed 360 mg/m2 in case of epirubicin and 280 mg/m2 in case of doxorubicin. adjuvant taxanes are allowed.
boolean
C1514457 (UMLS CUI [1,1])
C4084850 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0282564 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0014582 (UMLS CUI [3,1])
C2986497 (UMLS CUI [3,2])
C0013089 (UMLS CUI [4,1])
C2986497 (UMLS CUI [4,2])
C0796419 (UMLS CUI [5,1])
C1522673 (UMLS CUI [5,2])
Age
Item
9. age 18-75 years
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
10. life expectancy of greater than 3 months
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
11. ecog performance status <2
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function
Item
12. patients must have normal organ and marrow function:
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
White Blood Cell Count procedure
Item
leukocytes >=3,000/μl
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count >=1,500/μl
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets >=100,000/μl
boolean
C0032181 (UMLS CUI [1])
Bilirubin total normal
Item
total bilirubin within normal institutional limits
boolean
C0860928 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast(sgot)/alt(sgpt) <=1.5 x institutional upper limit of normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine normal
Item
creatinine within normal institutional limits
boolean
C0860945 (UMLS CUI [1])
Cardiac function | Left ventricular ejection fraction
Item
13. adequate cardiac function, i.e. left ventricular ejection fraction (lvef)>= 50%
boolean
C0232164 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence | Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
14. the effects of liposomal doxorubicin on the developing human fetus at the recommended therapeutic dose are unknown. for this reason and because anthracyclines as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. all women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to the start of study medication. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C2985296 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C0036899 (UMLS CUI [5])
C3831118 (UMLS CUI [6,1])
C0430061 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
Informed Consent
Item
15. ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent
Item
1. known diabetes (type 1 or 2)
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
Metformin | Sulfonylureas | Thiazolidinediones | Insulin
Item
2. currently on metformin, sulfonylureas, thiazolidenediones or insulin for any reason (these drugs alter insulin levels)
boolean
C0025598 (UMLS CUI [1])
C0038766 (UMLS CUI [2])
C1257987 (UMLS CUI [3])
C0021641 (UMLS CUI [4])
Congestive heart failure | Kidney Failure | Liver Failure | Acidosis Type Any | Alcohol consumption Alcoholic Beverages U/day
Item
3. current or previous congestive heart failure, renal failure or liver failure; history of acidosis of any type; habitual intake of 3 or more alcoholic beverages per day
boolean
C0018802 (UMLS CUI [1])
C0035078 (UMLS CUI [2])
C0085605 (UMLS CUI [3])
C0001122 (UMLS CUI [4,1])
C0332307 (UMLS CUI [4,2])
C1552551 (UMLS CUI [4,3])
C0001948 (UMLS CUI [5,1])
C0001967 (UMLS CUI [5,2])
C0456683 (UMLS CUI [5,3])
Serum creatinine raised | Aspartate aminotransferase increased
Item
4. creatinine above upper limit of normal for institution, ast above 1.5 times upper limit or normal for institution (to reduce risk of lactic acidosis)
boolean
C0700225 (UMLS CUI [1])
C0151904 (UMLS CUI [2])
Metformin allergy
Item
5. hypersensitivity or allergy to metformin
boolean
C0571648 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
6. participation in another clinical trial with any investigational agents within 30 days prior to study screening
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Metastatic malignant neoplasm to brain
Item
7. patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
boolean
C0220650 (UMLS CUI [1])
Allergic Reaction Compound Myocet Similar | Allergic Reaction Investigational New Drugs
Item
8. history of allergic reactions attributed to compounds of similar chemical or biologic composition to myocet or other agents used in the study
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C1512062 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
9. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
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