ID

26874

Description

Letrozole or Tamoxifen Citrate in Treating Older Postmenopausal Women Undergoing Surgery for Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00949598

Link

https://clinicaltrials.gov/show/NCT00949598

Keywords

Versions (1)
  1. 10/27/17 10/27/17 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 27, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT00949598

English

Eligibility Breast Cancer NCT00949598

1 forms  
Criteria
Description

Criteria

histologically confirmed invasive breast adenocarcinoma
Description

Breast adenocarcinoma Invasive

Data type

boolean

Alias
UMLS CUI [1,1]
C0858252
UMLS CUI [1,2]
C0205281
clinically t2 tumor and/or > 1 cm by echography
Description

TNM Breast tumor staging Ultrasonography | Tumor size Ultrasonography

Data type

boolean

Alias
UMLS CUI [1,1]
C0474926
UMLS CUI [1,2]
C0041618
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0041618
estrogen receptor (er)-positive and > 10% of the tumor cells positive
Description

Estrogen receptor positive | Neoplastic Cell Positive Percentage

Data type

boolean

Alias
UMLS CUI [1]
C0279754
UMLS CUI [2,1]
C0597032
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0439165
no er-negative disease
Description

Exclusion | Disease Estrogen receptor negative

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0279756
no prior breast cancer
Description

Exclusion | Breast Carcinoma Previous

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205156
no metastatic or inflammatory breast adenocarcinoma
Description

Exclusion Criteria | Breast adenocarcinoma metastatic | Breast adenocarcinoma inflammatory

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C1697918
UMLS CUI [3,1]
C0858252
UMLS CUI [3,2]
C0333348
patient characteristics:
Description

Client Characteristics

Data type

boolean

Alias
UMLS CUI [1]
C0815172
postmenopausal
Description

Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232970
no cardiac function that could contraindicate surgery or medical treatment (e.g., radiotherapy and/or chemotherapy)
Description

Exclusion Criteria | Cardiac function Contraindicated Operative Surgical Procedures | Cardiac function Contraindicated Therapeutic procedure | Therapeutic radiology procedure | Chemotherapy

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C1444657
UMLS CUI [2,3]
C0543467
UMLS CUI [3,1]
C0232164
UMLS CUI [3,2]
C1444657
UMLS CUI [3,3]
C0087111
UMLS CUI [4]
C1522449
UMLS CUI [5]
C0392920
no prior malignancies within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix
Description

Exclusion | Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2]
C0006826
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0699893
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0851140
no mental incapacitation that would preclude consent
Description

Exclusion | Mental handicap Preventing Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C1306341
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0021430
no contraindication to tamoxifen citrate or letrozole
Description

Exclusion Criteria | Medical contraindication Tamoxifen Citrate | Medical contraindication letrozole

Data type

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0079589
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0246421
prior concurrent therapy:
Description

Therapeutic procedure

Data type

boolean

Alias
UMLS CUI [1]
C0087111
more than 8 days since prior hormone-replacement therapy or other treatment (i.e., phytoestrogen) for menopause
Description

Hormone replacement therapy | Therapeutic procedure Menopause | phytoestrogen therapy

Data type

boolean

Alias
UMLS CUI [1]
C0282402
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0025320
UMLS CUI [3]
C1541283
no concurrent therapy that would modify the expression of the genes regulated by estrogen
Description

Exclusion | Therapeutic procedure Changing Estrogen Gene Expression Regulation

Data type

boolean

Alias
UMLS CUI [1]
C2828389
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0014939
UMLS CUI [2,4]
C0017263
no concurrent participation in another clinical study
Description

Study Subject Participation Status | Exclusion

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2828389
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Similar models

Eligibility Breast Cancer NCT00949598

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Breast adenocarcinoma Invasive
Item
histologically confirmed invasive breast adenocarcinoma
boolean
C0858252 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
TNM Breast tumor staging Ultrasonography | Tumor size Ultrasonography
Item
clinically t2 tumor and/or > 1 cm by echography
boolean
C0474926 (UMLS CUI [1,1])
C0041618 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0041618 (UMLS CUI [2,2])
Estrogen receptor positive | Neoplastic Cell Positive Percentage
Item
estrogen receptor (er)-positive and > 10% of the tumor cells positive
boolean
C0279754 (UMLS CUI [1])
C0597032 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0439165 (UMLS CUI [2,3])
Exclusion | Disease Estrogen receptor negative
Item
no er-negative disease
boolean
C2828389 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0279756 (UMLS CUI [2,2])
Exclusion | Breast Carcinoma Previous
Item
no prior breast cancer
boolean
C2828389 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Exclusion Criteria | Breast adenocarcinoma metastatic | Breast adenocarcinoma inflammatory
Item
no metastatic or inflammatory breast adenocarcinoma
boolean
C0680251 (UMLS CUI [1])
C1697918 (UMLS CUI [2])
C0858252 (UMLS CUI [3,1])
C0333348 (UMLS CUI [3,2])
Client Characteristics
Item
patient characteristics:
boolean
C0815172 (UMLS CUI [1])
Postmenopausal state
Item
postmenopausal
boolean
C0232970 (UMLS CUI [1])
Exclusion Criteria | Cardiac function Contraindicated Operative Surgical Procedures | Cardiac function Contraindicated Therapeutic procedure | Therapeutic radiology procedure | Chemotherapy
Item
no cardiac function that could contraindicate surgery or medical treatment (e.g., radiotherapy and/or chemotherapy)
boolean
C0680251 (UMLS CUI [1])
C0232164 (UMLS CUI [2,1])
C1444657 (UMLS CUI [2,2])
C0543467 (UMLS CUI [2,3])
C0232164 (UMLS CUI [3,1])
C1444657 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C1522449 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
Exclusion | Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix
Item
no prior malignancies within the past 5 years except for nonmelanoma skin cancer or carcinoma in situ of the cervix
boolean
C2828389 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Exclusion | Mental handicap Preventing Informed Consent
Item
no mental incapacitation that would preclude consent
boolean
C2828389 (UMLS CUI [1])
C1306341 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
Exclusion Criteria | Medical contraindication Tamoxifen Citrate | Medical contraindication letrozole
Item
no contraindication to tamoxifen citrate or letrozole
boolean
C0680251 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0079589 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0246421 (UMLS CUI [3,2])
Therapeutic procedure
Item
prior concurrent therapy:
boolean
C0087111 (UMLS CUI [1])
Hormone replacement therapy | Therapeutic procedure Menopause | phytoestrogen therapy
Item
more than 8 days since prior hormone-replacement therapy or other treatment (i.e., phytoestrogen) for menopause
boolean
C0282402 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0025320 (UMLS CUI [2,2])
C1541283 (UMLS CUI [3])
Exclusion | Therapeutic procedure Changing Estrogen Gene Expression Regulation
Item
no concurrent therapy that would modify the expression of the genes regulated by estrogen
boolean
C2828389 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0014939 (UMLS CUI [2,3])
C0017263 (UMLS CUI [2,4])
Study Subject Participation Status | Exclusion
Item
no concurrent participation in another clinical study
boolean
C2348568 (UMLS CUI [1])
C2828389 (UMLS CUI [2])
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