ID

26845

Description

Extended Endocrine Therapy for Premenopausal Women With Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00903162

Link

https://clinicaltrials.gov/show/NCT00903162

Keywords

Versions (1)
  1. 10/25/17 10/25/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 25, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00903162

English

Eligibility Breast Cancer NCT00903162

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
women 18 years of age or older
Description

Gender | Age

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
history of invasive er+ or pr+ breast cancer treated with at least 4.5 years of tamoxifen
Description

Invasive carcinoma of breast Estrogen receptor positive | Invasive carcinoma of breast Progesterone receptor positive | Tamoxifen

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0279754
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0279759
UMLS CUI [3]
C0039286
no current evidence of recurrent invasive disease or metastatic disease. patients may have a history of bilateral breast cancer
Description

Recurrent disease Invasive Absent | Neoplasm Metastasis Absent | Bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0277556
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0332197
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0281267
premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28 days)
Description

Premenopausal state | Estradiol measurement Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C0337434
UMLS CUI [2,2]
C0232969
liver function tests and creatinine <2.5 times the upper limit of normal within the 28 days prior to enrollment
Description

Liver Function Tests | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0023901
UMLS CUI [2]
C0201976
ecog performance status 0-1
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
must agree to use non-hormonal contraception (condoms, diaphragm, iud, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped
Description

Contraceptive methods | Exception Hormonal contraception | Female Condoms | Vaginal contraceptive diaphragm | Intrauterine Devices | Female Sterilization | Sexual Abstinence | Hormone Therapy Absent | Letrozole Discontinued

Data type

boolean

Alias
UMLS CUI [1]
C0700589
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C2985296
UMLS CUI [3]
C0221829
UMLS CUI [4]
C0042241
UMLS CUI [5]
C0021900
UMLS CUI [6]
C0015787
UMLS CUI [7]
C0036899
UMLS CUI [8,1]
C0279025
UMLS CUI [8,2]
C0332197
UMLS CUI [9,1]
C0246421
UMLS CUI [9,2]
C1444662
negative pregnancy test within 14 days prior to enrollment
Description

Pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0427780
patient must be able to speak, read and write in english
Description

Able to speak English Language | Able to read English Language | Able to write English Language

Data type

boolean

Alias
UMLS CUI [1,1]
C0564215
UMLS CUI [1,2]
C0376245
UMLS CUI [2,1]
C0586740
UMLS CUI [2,2]
C0376245
UMLS CUI [3,1]
C0584993
UMLS CUI [3,2]
C0376245
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with an oral or iv bisphosphonate in the prior two years
Description

Diphosphonates Oral | Diphosphonates Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0012544
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0012544
UMLS CUI [2,2]
C1522726
history of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix
Description

Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
women with evidence of current local recurrence or metastatic breast cancer
Description

Breast cancer recurrent Local | Secondary malignant neoplasm of female breast

Data type

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C0205276
UMLS CUI [2]
C0346993
pregnant women
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
nursing women
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
women who are currently taking tamoxifen and are unwilling to stop this medication
Description

Tamoxifen | Tamoxifen Discontinue Unwilling

Data type

boolean

Alias
UMLS CUI [1]
C0039286
UMLS CUI [2,1]
C0039286
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C0558080
women with a known deleterious brca 1 or brca 2 mutation
Description

Gender | BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0376571
UMLS CUI [2,2]
C2985436
UMLS CUI [3,1]
C0598034
UMLS CUI [3,2]
C2985436
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Similar models

Eligibility Breast Cancer NCT00903162

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
women 18 years of age or older
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Invasive carcinoma of breast Estrogen receptor positive | Invasive carcinoma of breast Progesterone receptor positive | Tamoxifen
Item
history of invasive er+ or pr+ breast cancer treated with at least 4.5 years of tamoxifen
boolean
C0853879 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C0039286 (UMLS CUI [3])
Recurrent disease Invasive Absent | Neoplasm Metastasis Absent | Bilateral breast cancer
Item
no current evidence of recurrent invasive disease or metastatic disease. patients may have a history of bilateral breast cancer
boolean
C0277556 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0281267 (UMLS CUI [3])
Premenopausal state | Estradiol measurement Premenopausal state
Item
premenopausal (estradiol level in premenopausal range, >20pg/ml, within the prior 28 days)
boolean
C0232969 (UMLS CUI [1])
C0337434 (UMLS CUI [2,1])
C0232969 (UMLS CUI [2,2])
Liver Function Tests | Creatinine measurement, serum
Item
liver function tests and creatinine <2.5 times the upper limit of normal within the 28 days prior to enrollment
boolean
C0023901 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
ECOG performance status
Item
ecog performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Contraceptive methods | Exception Hormonal contraception | Female Condoms | Vaginal contraceptive diaphragm | Intrauterine Devices | Female Sterilization | Sexual Abstinence | Hormone Therapy Absent | Letrozole Discontinued
Item
must agree to use non-hormonal contraception (condoms, diaphragm, iud, sterilization, abstinence, etc) and no other hormonal therapy during trial and until 3 months after letrozole is stopped
boolean
C0700589 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
C0221829 (UMLS CUI [3])
C0042241 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0015787 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
C0279025 (UMLS CUI [8,1])
C0332197 (UMLS CUI [8,2])
C0246421 (UMLS CUI [9,1])
C1444662 (UMLS CUI [9,2])
Pregnancy test negative
Item
negative pregnancy test within 14 days prior to enrollment
boolean
C0427780 (UMLS CUI [1])
Able to speak English Language | Able to read English Language | Able to write English Language
Item
patient must be able to speak, read and write in english
boolean
C0564215 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C0586740 (UMLS CUI [2,1])
C0376245 (UMLS CUI [2,2])
C0584993 (UMLS CUI [3,1])
C0376245 (UMLS CUI [3,2])
Item Group
C0680251 (UMLS CUI)
Diphosphonates Oral | Diphosphonates Intravenous
Item
previous treatment with an oral or iv bisphosphonate in the prior two years
boolean
C0012544 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0012544 (UMLS CUI [2,1])
C1522726 (UMLS CUI [2,2])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix
Item
history of cancer other than breast cancer within 5 years excluding basal/squamous cell skin carcinoma in situ of the cervix
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Breast cancer recurrent Local | Secondary malignant neoplasm of female breast
Item
women with evidence of current local recurrence or metastatic breast cancer
boolean
C0278493 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
Pregnancy
Item
pregnant women
boolean
C0032961 (UMLS CUI [1])
Breast Feeding
Item
nursing women
boolean
C0006147 (UMLS CUI [1])
Tamoxifen | Tamoxifen Discontinue Unwilling
Item
women who are currently taking tamoxifen and are unwilling to stop this medication
boolean
C0039286 (UMLS CUI [1])
C0039286 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
Gender | BRCA1 gene Deleterious Mutation | BRCA2 gene Deleterious Mutation
Item
women with a known deleterious brca 1 or brca 2 mutation
boolean
C0079399 (UMLS CUI [1])
C0376571 (UMLS CUI [2,1])
C2985436 (UMLS CUI [2,2])
C0598034 (UMLS CUI [3,1])
C2985436 (UMLS CUI [3,2])
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